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Log Reference # Summary of Issue

S 1. Introduction

S 765.CSD1 Needs expansion 1. Introduction

S 763.CSD1 Numbering

Spec or Metadata or OWL Location in Committee Spec

Draft docs

work group assigned

Public Review Comments begin with first listed below, prior #s are pre-public review

https://lists.oasis-open.org/archives/etmf-comment/201407/maillist.html#00002

11.CSD1 (ETMF-11)

Applicability to eTMF only or Clinical Trials domain

1.2 Normative - 1.3 Non-Normative References - Crossing list style

S 761.CSD1 1.2 Normative References

S 762.CSD1 OWL Citation - Bad Link 1.2 Normative References

S 764.CSD1 Formatting broken

S 514.CSD1 Source referenced 1.3 Non-Normative References

Normative Reference - bad reference

1.2 Normative References

S 121.CSD1 Contributions by participant 1.3 Non-Normative References

S 1.3 Non-Normative References

S 214.CSD1 Non-Norm Reference Usage 1.3 Non-Normative References

S 74.CSD1 Reference to TMF RM 1.3 Non-Normative References

S 769.CSD1 404 Reference

12.CSD1 (ETMF-12)

Include TMF Reference Model as a non-normative reference

1.3 Non-Normative References

S 163.CSD1 Cross-model Mapping 2. Problem Definition

S 2. Problem Definition

S 243.CSD1 General 2. Problem Definition

S 759.CSD1

S 2.1 Background

13.CSD1 (EMTF -13)

Focus Problem Addressed on content exchange between systems

Normative/Non-Normative references

2. Problem Definition

17.CSD1 (ETMF-17)

Clarify "...Preparing for regulatory submissions.."

S 2.1 Background

S 2.1 Background

S Document/Content formats 2.1 Background

16.CSD1 (ETMF-16)

Clarify definition used as "Archive"

14.CSD1 (ETMF-14)

Clinical Trial Content vs. eTMF Content

18.CSD1 (EMTF-18)

S Export formats requirement 2.1 Background

S References to EDMS are unclear 2.1 Background

S 20.CSD1 Use of CT Domain vs TMF Domain 2.1 Background

S 758.CSD1

S 244.CSD1 General

S 82.CSD1 eSubmissions 3.1 Oasis eTMF Standard Benefits

S 45.CSD1 Information exchange scope 3.1 Oasis eTMF Standard Benefits

19.CSD1 (ETMF-19)

15.CSD1 (ETMF-15)

Normative/Non-Normative references

3. Objective

3.1 OASIS eTMF Standard Benefits

S 46.CSD1 3.1 Oasis eTMF Standard Benefits

S 83.CSD1 Data exchange

S 746.CSD1

s 309.CSD1 Naming conventions 4. Core Technology Architecture

Reconsider reference to compliance

3.1 Oasis eTMF Standard Benefits (fourth bullet)

Normative and Non-Normative Text

4 Core Technology Architecture

S 756.CSD1

S 42.CSD1

S 41.CSD1

S 245.CSD1 General

S 44.CSD1

S 123.CSD1 Interoperability Impact

S 127.CSD1

Bad local reference 4.1 Description of the Architecture

Clarify statement re: TMF RM spreadsheet

4.1 Description of the Architecture

Correct reference to Standards Organizations



Grammer correction & Clarification



Metadata Vocab Interoperability Layer - 'Industry Group Terms'


S 43.CSD1 Remove reference to ISO standard

S 38.CSD1 Change Domain Reference 5. Content Classification System

S 745.CSD1 5. Content Classification System



Correction to XML Naming Rule, Appendix reference, CCS numbering, Non-Normative Language

Cross-study document management

S 310.CSD1 Mapping 5. Content Classification System


S/MV 824.CSD1 Use Case 5. Content Classification System

S 809.CSD1 Content Type definition

S 515.CSD1 Content Classification System 5.1 Classification Categorization

Standard Updates & Version Control

5.1 5.1 Classification Categorization

S 755.CSD1 5.1 Classification Categorization

S 37.CSD1 5.1 Classificatoin Categorization

S 84.CSD1 Correspondence to TMF RM 5.1 Classificatoin Categorization

Missing normative reference for UDC

Categories, Subcategories & Content Type usage adds complexity

S 240.CSD1 General 5.1 Classificatoin Categorization

S 247.CSD1 Reference to TMF RM 5.1 Classificatoin Categorization

S 241.CSD1 Term Use 5.1 Classificatoin Categorization

S 85.CSD1 Content Entities

S 754.CSD1

S 248.CSD1 References

5.1.1 Content Entities, Hierarchy, and Numbering System

Undefined term: "Classification entity", in this context

5.1.1 Content Entities, Hierarchy, and Numbering System

5.1.1.2 Classification Categories Naming Scheme

S 516.CSD1 Content Classification System

S 810.CSD1 Standards references

S 249.CSD1 Correction to PT

S 261.CSD1 Correction to PT

S 36.CSD1

S 250.CSD1 Subcategory numbering reference

5.1.1.2 - Classification Categories Naming Scheme

5.1.1.2 5.1.1.2 Classification Categories Naming Scheme



Standardized category naming not essential



S 753.CSD1

S 517.CSD1 Figure correction 5.1.1.3 – Figure 9

S 251.CSD1 General

S 252.CSD1 General

S 752.CSD1

Unclear if section content is original or an import from UDC.


5.1.1.4 Rules to Modify/Create Classification Categories Entities


Terms definitions not visible, too late and unreferred


S 34.CSD1

S 47.CSD1 Clarification to Table 1

S 129.CSD1 Code useage

S 33.CSD1

S 128.CSD1 Metadata tags by

S 130.CSD1 Modification Rules/Process

S 239.CSD1 General 5.2 Metadata Definitions

S 255.CSD1 General 5.2.1 Metadata Properties

Categories, Subcategories & Content Type usage




Interoperability related to new content types




S 254.CSD1 Terminology used 5.2.1 Metadata Properties

S 256.CSD1 Use Cases 5.2.1 Metadata Properties

S 811.CSD1 Terms continuity 5.2.1 5.2.1 Metadata Properties

S 30.CSD1 Correction to Figure reference 5.2.1 Metadata Properties

S 31.CSD1 Description revision 5.2.1 Metadata Properties

S 32.CSD1 5.2.1 Metadata Properties

S 253.CSD1 References used 5.2.1 Metadata Properties

S 131.CSD1 Organization Specific Metadata

S 86.CSD1 Data Properties 5.3.1 Content Model Format

Presentation of metadata categories

5.2.1.1 Rules to Modify/Create Metadata Terms

S 760.CSD1 5.3.1 Content Model Format

S 81.CSD1 Versioning 5.3.3 Content Model Versioning

S 87.CSD1 Media Types 6.1 OASIS eTMF Data Model

S 132.CSD1 Media Types 6.1 OASIS eTMF Data Model

S 812.CSD1 Clarify 6.1 OASIS eTMF Data Model

S 40.CSD1 Clarify statement 6.1 Oasis eTMF Data Model

Missing Normative Reference

S 39.CSD1 Content Model clarifcation 6.1 Oasis eTMF Data Model

S 257.CSD1 Reference to export formats 6.1 Oasis eTMF Data Model

S 124.CSD1 eCTD format

S 133.CSD1 eCTD format

S 35.CSD1

S 63.CSD1 Media Types

S 125.CSD1 SAE data exchange

S 262.CSD1 TMF RM reference

6.1.1 Oasis eTMF Data Model Exchange Format


Include other global regulatory agencies re: eCTD submission





S 744.CSD1

S 29.CSD1

S 88.CSD1 Taxonomy

S 134.CSD1 Taxonomy

Clarify references to Normative vs Non-normative

6.1.1 OASIS eTMF Data Model Exchange Format, XML = Interchange?

Specify use cases for content exchange

6.1.2 OASIS eTMF Exchange Package



S 26.CSD1

S 89.CSD1 Digital Signatures



S 135.CSD1 Electronic signatures

S 24.CSD1

Ambiguous reference to electronic signing party verification

6.2 Electronic & Digital Signatures





Insufficient detail for Interoperability of electronic signatures


S 28.CSD1

S 27.CSD1 Spell out acronym RSA

S 143.CSD1 Electronic signatures

S 215.CSD1 Description revision

S 813.CSD1 Digital Signature reference

S 238.CSD1 General

Qualify statement re: digital signer validation



6.2 Electronic & Digital Signatures ? Not sure what the reference to page 35 is.

6.2 Electronic and Digital Signatures



S 258.CSD1 General

S 259.CSD1 Terminology used

S 743.CSD1 Non-Normative References

S 136.CSD1 BPM Workflows 6.3 Business Process Model

S 216.CSD1 6.3 Business Process Model

S 260.CSD1 electronic and digital signatures 6.3 Business Process Model

S 814.CSD1 Use 6.3 Business Process Model



6.2 Electronic and Digital Signatures and 6.3 Business Process Modeling

Business Process Model application

S 25.CSD1 6.3 Business Process Model

S 92.CSD1 Business Process 6.3 Business Process Model

S 750.CSD1 7. Conformance


Add eTMF-relevant business process vocabulary

Duplicate numbering and use of 1.1

Missing crucial normative references

S 747.CSD1 7. ConformanceNeed for more than one conformance clause


S 22.CSD1 Redundant text 7. Conformance

Notion of "implementation" not precise enough for a conformance target



S 93.CSD1 Core Metadata 7. Conformance, a.III.

Reference to regulations not necessary

The conformance clause relationship to normative content in specification is vague at best

S 21.CSD1 Acknowledgement of TMF RM Appendix A. Acknowledgments

S 263.CSD1 Reference used Appendix C

S 61.CSD1 Add Trial Master File Appendix C. Glossary

S 57.CSD1 Change definition and source Appendix C. Glossary

S 58.CSD1 Appendix C. Glossary

S 60.CSD1 Change NCI definition/source Appendix C. Glossary

S 59.CSD1 Correct citation for eCTD Appendix C. Glossary

Change definition scope and source

S 116.CSD1 Reference used Appendix C. Glossary, 'eCTD'

S 115.CSD1 Reference used Appendix C. Glossary, 'eTMF'

S 101.CSD1 Core Metadata





S 99.CSD1 Document Versioning

S 98.CSD1 General

S 100.CSD1 Document Versioning

S 94.CSD1 Business Process



B. 2.1 Core Metadata, Table 8, Basic Audit Trail, 'Created By'

B. 2.1 Core Metadata, Table 8, Business Process,

B. 2.1 Core Metadata, Table 8, Business Process, 'Date'

B. 2.1 Core Metadata, Table 8, Business Process, 'Subject Identifier'

B. 2.1 Core Metadata, Table 8, Classification, 'Content Type Name'

B. 2.1 Core Metadata, Table 8, File Properties, 'Content Identifier'

B. 2.1 Core Metadata, Table 8, File Properties, 'Modified'

B. 2.1 Core Metadata, Table 8, File Properties, 'Document Version'

B.2 Oasis eTMF Model Metadata Properties; table 7, Business Processes, 1st bullet

B.2 Oasis eTMF Model Metadata Properties; table 7, Business Processes, 2nd bullet

B.2 Oasis eTMF Model Metadata Properties; table 7, Business Processes, 4th bullet


S 64.CSD1 Audit Trail

S 49.CSD1 Business Process question B.2.1 Core Metadata

S 48.CSD1 Clarify use of County Code B.2.1 Core Metadata

S 137.CSD1 Date metadata B.2.1 Core Metadata

S 53.CSD1 Explain Digital Signature Field B.2.1 Core Metadata

S 138.CSD1 Fax metadata B.2.1 Core Metadata

S 141.CSD1 Large Images B.2.1 Core Metadata

S 50.CSD1 Person Name, Person Role usage B.2.1 Core Metadata

B.2 Oasis eTMF Model Metadata Properties; table 7, Business Processes, 5th bullet

B.2 Oasis eTMF Model Metadata Properties, Table 7

S 139.CSD1 Specificity capacity B.2.1 Core Metadata

S 52.CSD1 Subject Identifier usage B.2.1 Core Metadata

S 140.CSD1 Time metadata B.2.1 Core Metadata

S 51.CSD1 Username usage B.2.1 Core Metadata

S 70.CSD1 Domain metadata B.2.2 Domain Based Metadata

MV 106.CSD1 Domain Metadata

MV 54.CSD1 Specification purpose



B.2.2 Domain Based Metadata (eTMF Domain Example)

B.2.2 Domain Based Metadata (eTMF Domain Example)

B.2.2 Domain Based Metadata (eTMF Domain Example), 'Credential'

B.2.2 Domain Based Metadata (eTMF Domain Example), 'Credential''

MV 108.CSD1 eCTD use


S 109.CSD1 Domain Metadata

S 554.CSD1 Use B.2.3 General Metadata

S 555.CSD1 General

S 556.CSD1 General

S 110.CSD1 Metadata clarification

B.2.2 Domain Based Metadata (eTMF Domain Example), 'eCTD Item'

B.2.2 Domain Based Metadata (eTMF Domain Example), 'eCTD Item''

B.2.2 Domain Based Metadata (eTMF Domain Example), 'eCTD Item''

B.2.3 General Metadata 'Cross Reference'

B.2.3 General Metadata 'Term Source'

B.2.3 General Metadata, 'Description'

S 111.CSD1 Metadata clarification

S 112.CSD1 Metadata clarification B.2.3 General Metadata, 'Title'

S 113.CSD1 Metadata clarification B.2.3 General Metadata, 'Type'

S 552.CSD1 Use B.3 Annotation Properties

S 55.CSD1 Use of term Archive B.3 Annotation Properties

S 551.CSD1 Definition

S 553.CSD1 Mapping

S 146.CSD1 Code Curation

B.2.3 General Metadata, 'Location'

B.3 Annotation Properties 'Country Code'

B.3 Annotation Properties 'eCTC Item'

B.3 Annotation Properties, C115478 "Code"

S 56.CSD1 Use only C & Z Codes

S 557.CSD1 Add Metadata

S 67.CSD1 Versioning

S 75.CSD1 Versioning & Mapping

S 558.CSD1 Reference

S 114.CSD1 Versioning

MV 726.CSD1 Data Properties C101129 Task

B.3 Annotation Properties, C115478 "Code"

B.4 Document Version Numbering Policies



B.4 Document Version Numbering Policies 'eCTD'

B.4 Document Versioning Numbering Policies, 1st paragraph

MV 416.CSD1 Data Properties C114457 Repository

MV 415.CSD1 Data Properties C114463 Archive

MV 493.CSD1 Definition C114463 Archive

MV 289.CSD1 General C114463 'Archive'

MV 414.CSD1 Preferred Term

MV 492.CSD1 General

MV 712.CSD1 General

MV 721.CSD1 Data Properties C114551 Organization Role


C114548 CareLex eTMF Terminology



C115462 Template Advertisement for Subject Recruitment



MV 152.CSD1 Use of 'Template'


MV 791.CSD1 Content Types

MV 160.CSD1 IRB Content Types

MV 527.CSD1 General

C115462 'Template Advertisement for Subject Recruitment'




C115463 IRB-IEC Approved Advertisement for Subject Recruitment

C115463, C115560, C115588, C115693, C115697, C115700, C115701 Domain Metadata


MV 615.CSD1 Use


MV 224.CSD1 Definition

MV 586.CSD1 Concur

MV 290.CSD1 Concur C115468

MV 494.CSD1 Definition C115468 Category

MV 427.CSD1 C115469 Audit Certificate

MV 648.CSD1 Concur


C115465 Vendor Confidentiality Agreement

C115466 'Import-Export License Application'

C115466 'Import-Export License Application'

Add content types (TMF RM 236 & 237)

C115470 IRT User Acceptance Testing Certification


MV 600.CSD1 Concur




MV 685.CSD1 Concur


MV 480.CSD1 Concur


MV 266.CSD1 Synonym & Definition

C115476 Investigator Confidentiality Agreement



C115480 'IRB-IEC Sponsor Communications and Tracking ' (subcateg)

C115480 'IRB-IEC Sponsor Communications and Tracking ' (subcateg)

C115482 Edit Check Programming

C115484 Interim Analysis Programs

C115484 Interim Analysis Programs

C115485 'Independent Data Monitoring Committee Correspondence'

MV 157.CSD1 Study Team CV

MV 564.CSD1 Abbreviation C115489 Trial Team Member CV



MV 682.CSD1 Concur

MV 295.CSD1 Concur

MV 481.CSD1 Concur


MV 293.CSD1 Concur

MV 479.CSD1 Concur


MV 795.CSD1 Use

C115488 'Sub-Investigator Curriculum Vitae'

C115490 Laboratory Director Curriculum Vitae

C115490 Laboratory Director Curriculum Vitae

C115491 Electronic Data Capture Final Output

C115493 Interim Analysis Datasets



C115495 Interim Analysis Raw Datasets



C115496 Study Subjects Digital Photos



MV 560.CSD1 Synonym

MV 425.CSD1 Preferred Term C115497 Trial Operations

MV 701.CSD1 Concur C115498 Trial Unblinding

MV 803.CSD1 Use

MV 460.CSD1 Concur

MV 669.CSD1 Concur

MV 477.CSD1 Concur

MV 699.CSD1 Concur

MV 445.CSD1 Concur

C115497 'Trial Operations ' (subcateg)



C115499 Computed Tomography (subcateg)

C115504 Centralized Testing Filenote

C115504 Centralized Testing Filenote

C115505 Data Management Filenote

C115505 Data Management Filenote

C115506 IP and Trial Supplies Filenote

MV 652.CSD1 Concur

MV 448.CSD1 Concur C115507 Safety Filenote

MV 656.CSD1 Concur C115507 Safety Filenote

MV 488.CSD1 Concur C115508 Statistics Filenote

MV 711.CSD1 Concur C115508 Statistics Filenote

MV 467.CSD1 Concur C115509 Vendor Filenote

MV 676.CSD1 Preferred Term C115509 Vendor Filenote

MV 799.CSD1 Use C115510 Study Subject CT report

MV 802.CSD1 Use

MV 798.CSD1 Use

MV 800.CSD1 Use

MV 797.CSD1 Use

C115506 IP and Trial Supplies Filenote

C115511 Study Subject Medical Imaging Unspecified

C115512 Study Subject MRI Report

C115513 Study Subject Nuclear Medicine

C115514 Study Subject Radiology Report

MV 801.CSD1 Use

MV 796.CSD1 Use





MV 204.CSD1 Preferred Term C115518 'Other Subject Forms'





C115515 Study subject Ultrasound

C115516 Study Subjects Digital Photos Report

C115517 'Subject Information Form'

C115517 Subject Information Form

C115517 Subject Information Form





MV 680.CSD1 Concur


MV 470.CSD1 Preferred Term C115521 Data Clarification Forms

MV 681.CSD1 Preferred Term C115521 Data Clarification Forms



C115519 'Subject Participation Form'




C115520 Completed Case Report Forms

C115520 Completed Case Report Forms

C115524 Site Personnel Supporting Information


MV 786.CSD1 Synonym

MV 189.CSD1 Definition C115526 'Investigator Brochure'

MV 518.CSD1 Preferred Term C115529 PI License

MV 156.CSD1 Definition C115529 'PI License'

MV 385.CSD1 Use Cases C115529 PI License

MV 603.CSD1 Preferred Term C115529 PI License


MV 587.CSD1 Concur C115530 Import-Export License

MV 176.CSD1 Definition C115531 'Filenote Master List'




C115529 PI License & C115524 Site Personnel Supporting Information

C115532 'Independent Data Monitoring Committee Member List'

C115532 'Independent Data Monitoring Committee Member List'

MV 158.CSD1

MV 519.CSD1 Preferred Term C115537 Subject Enrollment Log

MV 607.CSD1 Concur C115538 Subject Screen Log

MV 388.CSD1 Preferred Term C115538 Subject Screen Log

MV 787.CSD1 Preferred Term C115538 Subject Screen Log

MV 660.CSD1 Concur C115541 Lab Manual

Subject Enrollment Log & Subject Screen Log

C115537 & C115538 'Subject Enrollment Log' and 'Subject Screen Log'

MV 453.CSD1 Preferred Term C115541 Lab Manual



MV 210.CSD1 Concur C115546 Central Trial Filenote


MV 366.CSD1 General C115546 Central Trial Filenote


MV 187.CSD1 Abbreviation C115547 'Trial Filenote'

MV 185.CSD1 Preferred Term C115547 'Trial Filenote'

MV 349.CSD1 Preferred Term C115547 'Trial Filenote'

C115542 Bioanalytical Validation Methods

C115542 Bioanalytical Validation Methods

MV 186.CSD1 Synonym C115547 'Trial Filenote'

MV 571.CSD1 Concur C115547 'Trial Filenote'

MV 229.CSD1 Concur C115548 Regulatory Filenote

MV 594.CSD1 Concur C115548 Regulatory Filenote

MV 433.CSD1 Concur

MV 631.CSD1 Concur

MV 598.CSD1 Concur C115550 IRB-IEC Filenote


C115549 Site Management Filenote

C115549 Site Management Filenote

C115551 'Notification of Safety Information'

MV 588.CSD1 Use

MV 296.CSD1 Concur C115555 Interim Analysis Output

MV 482.CSD1 Concur C115555 Interim Analysis Output

MV 705.CSD1 Preferred Term C115555 Interim Analysis Output

MV 177.CSD1 Concur



MV 341.CSD1 Abbreviation C115557 Publication Policy

C115551 'Notification of Safety Information'

C115556 'Clinical Trial Oversight Committees' (subcateg)

C115556 Clinical Trial Oversight Committees (Subcateg)

C115556 Clinical Trial Oversight Committees (Subcateg)

MV 173.CSD1 Definition C115557 'Publication Policy'



MV 529.CSD1 General

MV 617.CSD1 Use

MV 633.CSD1 Concur C115564 IP Accountability Record

MV 649.CSD1 Concur

MV 437.CSD1 Preferred Term C115566 IP Return Record

MV 637.CSD1 Preferred Term C115566 IP Return Record

MV 632.CSD1 Preferred Term C115567 IP Shipment Record

C115559 Subject Questionnaire Form

C115559 Subject Questionnaire Form

C115560 IRB-IEC Approved Subject Questionnaire

C115560 IRB-IEC Approved Subject Questionnaire

C115565 IP and Trial Supplies Communications

MV 434.CSD1 Preferred Term C115568 IP Transfer Record

MV 634.CSD1 Preferred Term C115568 IP Transfer Record

MV 664.CSD1 Concur


MV 665.CSD1 Concur

MV 707.CSD1 General



MV 452.CSD1 Preferred Term C115573 Bioanalytical Reports

MV 659.CSD1 Preferred Term C115573 Bioanalytical Reports

C115569 Laboratory Shipment Records

C115569 Laboratory Shipment Records

C115570 Record of Retained Body Fluids or Tissue Samples

C115571 Statistical Report Records

C115572 Subject Unblinding Event

C115572 Subject Unblinding Event



MV 611.CSD1 Synonym

MV 806.CSD1 Synonym

MV 389.CSD1 Synonym C115577 Monitoring Visit Report

MV 788.CSD1 Synonym C115577 Monitoring Visit Report


MV 342.CSD1 Abbreviation C115580 'Trial Status Report'

MV 175.CSD1 Definition C115580 'Trial Status Report'

MV 159.CSD1 Rationale question

MV 484.CSD1 Concur C115582 Statistical Report

MV 626.CSD1 Preferred Term C115584 IRB-IEC Report

MV 297.CSD1 Concur

MV 483.CSD1 Concur

C115575 'Central Trial Final Reports' (Subcateg)

C115575 'Central Trial Final Reports' (Subcateg)

C115576 Trial Initiation Monitoring Report

C115576 Trial Initiation Monitoring Report

C115579 Trial Regulatory Status Reporting (subcateg)

C115581 'Final Trial Close Out Monitoring Report'

C115585 Interim Statistical Reports

C115585 Interim Statistical Reports

MV 601.CSD1 Synonym

MV 805.CSD1 Synonym

MV 528.CSD1 General

MV 616.CSD1 Use

MV 199.CSD1 Preferred Term C115589 'Subject Diary Form'



MV 683.CSD1 Concur C115590 Database Specification

MV 688.CSD1 Concur

MV 174.CSD1 Definition C115593 'Debarment Statement'

C115586 Pre Trial Monitoring Report

C115586 Pre Trial Monitoring Report

C115588 IRB-IEC Approved Subject Diary

C115588 IRB-IEC Approved Subject Diary

C115591 External Data Transfer Specifications

MV 623.CSD1 Concur

MV 642.CSD1 Preferred Term C115595 TSE Statement

MV 363.CSD1 General

MV 579.CSD1 Concur

MV 207.CSD1 Concur


MV 209.CSD1 Concur

MV 365.CSD1 General

MV 581.CSD1 Concur

MV 279.CSD1 Concur

MV 668.CSD1 Concur

C115594 IRB-IEC GCP Compliance Statement

C115596 Central Trial Communications



C115596 'Central Trial Communications'

C115597 Central Trial Meeting Material




C115598 Centralized Testing Meeting Material

MV 570.CSD1 Concur

MV 628.CSD1 Concur

MV 630.CSD1 Concur



MV 346.CSD1 Preferred Term C115605 Trial Start Up (subcateg)


MV 567.CSD1 Synonym

MV 698.CSD1 Concur

C115601 Trial Management Meeting Material

C115602 Site Management Communications

C115603 Site Management Meeting Material

C115605 'Trial Start Up' (subcateg)

C115605 'Trial Start Up' (subcateg)

C115606 Trial Team Training Material

C115606 Trial Team Training Material

C115607 Data Management Meeting Material

MV 595.CSD1 Concur

MV 597.CSD1 Concur

MV 651.CSD1 Concur


MV 591.CSD1 Concur

MV 228.CSD1 Concur

MV 593.CSD1 Concur

MV 655.CSD1 Concur C115613 Safety Meeting Material

MV 487.CSD1 Concur

C115608 IRB-IEC Communications

C115609 IRB-IEC Meeting Material

C115610 IP and Trial Supplies Meeting Material

C115611 Regulatory Communications

C115612 Regulatory Meeting Material

C115612 Regulatory Meeting Material

C115614 Statistics Meeting Material

MV 710.CSD1 Concur


MV 612.CSD1 Concur C115616 IRB-IEC Submission

MV 393.CSD1 Use Cases

MV 270.CSD1 Definition C115617 Trial Team (subcateg)

MV 740.CSD1 Definition C115617 Trial Team (subcateg)

MV 684.CSD1 Use C115620 Data Validation Plan

MV 700.CSD1 Concur


MV 194.CSD1 Abbreviation C115627'Protocol Amendment'

C115614 Statistics Meeting Material

C115615 Vendor Meeting Material

C115616 IRB-IEC Submission & C70800, C115697,C115463, C115588, C115560, C115700, C115701, C115693,

C115621 Randomization Validation

C115621 Randomization Validation

MV 193.CSD1 Preferred Term C115627'Protocol Amendment'

MV 687.CSD1 Concur





MV 208.CSD1 Concur

MV 580.CSD1 Concur

C115634 Approval for Database Activation

C115636 'Central Trial Documents'

C115637 'Central Trial Documents Communications and Tracking' (Subcateg)

C115638 Central Trial Tracking Document

C115637 'Central Trial Documents Communications and Tracking' (Subcateg)




MV 666.CSD1 Concur


MV 667.CSD1 Concur


MV 449.CSD1 Preferred Term C115642 Centralized Testing





C115638 'Central Trial Tracking Document'

C115639 Centralized Testing Communications

C115640 Centralized Testing Communications and Tracking

C115641 Centralized Testing Tracking Document

C115641 Centralized Testing Tracking Document

C115646 Core Trial Documents (subcateg)

C115647 'Dose Escalation Documents'




MV 195.CSD1 Definition C115651 'Insurance'

MV 663.CSD1 Concur





MV 568.CSD1 Concur

MV 184.CSD1 Concur

MV 780.CSD1 Use

MV 775.CSD1 Use


MV 569.CSD1 Concur


C115650 'Independent Data Monitoring Committee Charter'

C115653 Interfacility Standardization Methods

C115654 Investigator Documents

C115655 Laboratory Sample Details

C115656 'Trial Management Documents Communications and Tracking' (subcateg)

C115656 'Trial Management Documents Communications and Tracking' (subcateg)

C115657 Trial Management Communications

C115658 'Trial Management Tracking Documents'



C115658 Trial Management Tracking Documents




MV 563.CSD1 Synonym C115659 Trial Team Details

MV 590.CSD1 Concur

MV 390.CSD1 Abbreviation C115664 Protocol Deviations


MV 227.CSD1 Concur


MV 592.CSD1 Concur

MV 284.CSD1 Concur

MV 783.CSD1 Use

MV 629.CSD1 Concur


C115662 Regulatory Notification of Trial Termination

C115665 Trial Approval (subcateg)

C115666 Regulatory Tracking Document



C115666 'Regulatory Tracking Document'


C115670 Site Management Tracking Document



MV 380.CSD1 Synonym


MV 387.CSD1 Preferred Term C115673 Site Signature Sheet



MV 274.CSD1 Concur



MV 440.CSD1 Preferred Term C115677 Trial Supply Storage



C115670 Site Management Tracking Document

C115670 Site Management Tracking Document, C115704, C115728,

C115671 Study Site Personnel Details

C115671 Study Site Personnel Details

C115675 Subject Document Forms (subcateg)

C115675 'Subject Document Forms' (subcateg)

C115675 Subject Document Forms (subcateg)

C115676 Trial Supply Storage Conditions

C115676 Trial Supply Storage Conditions

C115678 Trial Supply Storage Condition Excursions

C115678 Trial Supply Storage Condition Excursions

MV 696.CSD1 Concur



MV 697.CSD1 Concur


MV 694.CSD1 Concur



MV 686.CSD1 Concur C115686 Data Validation Testing

MV 693.CSD1 Concur

C115680 Data Management Communications

C115681 Data Management Communications and Tracking (subcateg)

C115682 Data Management (categ)

C115684 Data Management Tracking Document

C115684 Data Management Tracking Document

C115685 Data Validation Certification



C115687 Database Account Management







MV 153.CSD1 Category




C115690 Evidence of Contractor Compliance




C115691 'IRB-IEC Sponsor Communication' (categ)




MV 314.CSD1 Concur


MV 596.CSD1 Concur

MV 804.CSD1 Use


C115691 IRB-IEC Sponsor Communication (categ)


C115692 IRB-IEC Tracking Document

C115692 IRB-IEC Tracking Document

C115692 IRB-IEC Tracking document

MV 532.CSD1 General

MV 620.CSD1 Use

MV 621.CSD1 Concur C115694 IRB-IEC Composition

MV 394.CSD1 Use Cases

MV 622.CSD1 Concur

MV 523.CSD1 Category not subcategory C115696 IRB-IEC Documents

C115693 IRB-IEC Approved Other Subject Information

C115693 IRB-IEC Approved Other Subject Information

C115694 IRB-IEC Composition, C115695, C115594, C115583 IRB-IEC Trial Status Reporting, C115698, C115584, C115699

C115695 IRB-IEC Documentation of Non-Voting Status

MV 821.CSD1 Use case C115696 IRB-IEC Documents

MV 412.CSD1 Use Cases C115696 IRB-IEC Documents

MV 392.CSD1 Use Case

MV 526.CSD1 General

MV 614.CSD1 Use

MV 627.CSD1 Concur

C115696 IRB-IEC Documents (subcateg)

C115697 IRB-IEC Approved Informed Consent

C115697 IRB-IEC Approved Informed Consent

C115699 IRB-IEC Notification of Trial Termination

MV 530.CSD1 General

MV 618.CSD1 Use

MV 531.CSD1 General

MV 619.CSD1 Use

MV 222.CSD1 Subcategory Necessity



MV 650.CSD1 Concur


MV 335.CSD1 Definition C115705 'IP Documentation'


C115700 IRB-IEC Approved Subject Information

C115700 IRB-IEC Approved Subject Information

C115701 IRB-IEC Approved Subject Participation

C115701 IRB-IEC Approved Subject Participation

C115702 'Investigational Medicinal Product' (subcateg)

C115702 Investigational Medicinal Product (subcateg)

C115702 'Investigational Medicinal Product' (subcateg)

C115704 IP and Trial Supplies Tracking Document

C115704 IP and Trial Supplies Tracking Document

C115706 IP Documents Communications and Tracking

MV 641.CSD1 Preferred Term C115708 IP Regulatory Release

MV 606.CSD1 Synonym

MV 285.CSD1 Concur



MV 450.CSD1 Preferred Term C115712 Laboratory Certification

MV 657.CSD1 Preferred Term C115712 Laboratory Certification

MV 691.CSD1 Concur C115714 Dictionary Coding

S 162.CSD1 Content Classification System

C115710 IP Site Release Documentation

C115711 Acceptance of Investigator Brochure



C115715 'Medical Imaging' (categ)

MV 511.CSD1 Imaging Documents Use case C115715 Medical Imaging

MV 822.CSD1 Content Types Use case C115715 Medical Imaging

MV 489.CSD1 Use case

MV 410.CSD1 TMF RM Alignment C115715 Medical Imaging (categ)

MV 408.CSD1 Use case C115715 Medical Imaging (categ)

MV 794.CSD1 Use C115715 Medical Imaging (categ)

C115715 Medical Imaging C115500, C115496, C115516, C115721, C115561, C115514, C115501, C115539, C115512, C115499, C115481, C115510, C115502, C115553, C115513, C115503, C115619, C115515, C115545, C115511

MV 533.CSD1 Use case C115715 Medical Imaging

MV 298.CSD1 Concur

MV 395.CSD1 Synonym


MV 792.CSD1 Synonym

MV 524.CSD1 Concur


MV 583.CSD1 Synonym

C115716 Submissions Non-IRB-IEC Committees




C115716 Submissions Non-IRB-IEC Committees and C115736 Other Approvals

C115720 Qualified Person Certification

C115723 'Regulatory Documentation'

S 218.CSD1 Definition

MV 367.CSD1 Country Code


MV 690.CSD1 Concur


MV 653.CSD1 Concur C115726 Safety Communications


MV 654.CSD1 Concur



C115723 'Regulatory Documentation'

C115723 'Regulatory Documentation' (categ)

C115724 Regulatory Documentation Communications and Tracking (subcateg)

C115725 Serious Adverse Event Data Reconciliation

C115725 Serious Adverse Event Data Reconciliation

C115727 Safety Reporting Communications and Tracking

C115728 Safety Tracking Document

C115728 Safety Tracking Document

C115729 Statistics Communication and Tracking (subcateg)

MV 709.CSD1 Concur


MV 708.CSD1 Concur


MV 282.CSD1 References used


MV 706.CSD1 Concur


MV 396.CSD1 Preferred Term C115736 Other Approvals

MV 793.CSD1 Preferred Term C115736 Other Approvals

MV 625.CSD1 Use C115736 Other Approvals

C115730 Statistics Tracking Document

C115730 Statistics Tracking Document

C115731 Statistics Communications

C115734 'Study Registry Documents'



C115735 Subject Evaluability Criteria and Subject Classification


MV 661.CSD1 Concur


MV 382.CSD1 Abbreviation

MV 271.CSD1 General



MV 344.CSD1 Synonym




C115737 Supplementary Monitoring Activity

C115738 Lab Supply Import Documentation

C115738 Lab Supply Import Documentation

C115739 Sites Evaluated but not Selected

C115740 'Non-IDMC Trial Committee Documents Unspecified'



C115740 Non-IDMC Trial Committee Documents Unspecified

C115740 Non-IDMC Trial Committee Documents Unspecified

C115741 Vendor Communications

C115742 Vendors Communications and Tracking

MV 404.CSD1 Preferred Term C115743 Vendors (categ)

MV 461.CSD1 Preferred Term C115743 Vendors (categ)

MV 400.CSD1 Synonym C115744 Vendor Oversight






MV 679.CSD1 Concur


MV 678.CSD1 Concur

MV 689.CSD1 Concur C115751 Data Entry Guidelines

MV 426.CSD1 Missing content types

MV 172.CSD1 Synonym C115753 'Monitoring Plan'

C115745 Vendor Records (subcateg)

C115745 Vendor Records (subcateg)

C115746 Vendor Roles and Responsibilities

C115748 Vendor Tracking Document

C115748 Vendor Tracking Document

C115749 Annotated Case Report Form

C115749 Annotated Case Report Form

C115750 CRF Completion Requirements

C115752 Medical Monitoring Plan

MV 340.CSD1 Synonym C115753 'Monitoring Plan'

MV 677.CSD1 Concur C115756 Data Management Plan

MV 692.CSD1 Concur C115757 Database Quality Plan

MV 472.CSD1 Definition C115757 Database Quality Plan

MV 436.CSD1 Preferred Term C115758 IP Recall Plan

MV 636.CSD1 Preferred Term C115758 IP Recall Plan

MV 435.CSD1 Preferred Term C115759 IP Re-labeling Plan

MV 635.CSD1 Preferred Term C115759 IP Re-labeling Plan


MV 773.CSD1 Synonym

MV 561.CSD1 Synonym C115765 Trial Master File Plan



MV 559.CSD1 Synonym

C115764 'Operational Procedure Manual'

C115764 Operational Procedure Manual

C115766 'Trial Management ' (categ)

C115766 Trial Management (Categ)

C115766 Trial Management (Categ)

MV 643.CSD1 Concur C115776 IP Randomization Plan

MV 167.CSD1 Synonym C115777 'Quality Plan'

MV 771.CSD1 Synonym C115777 'Quality Plan'

MV 337.CSD1 Preferred Term and Synnonym C115777 Quality Plan

MV 169.CSD1 Abbreviation C115779 'SOP List'

MV 170.CSD1 Definition C115779 'SOP List'

MV 772.CSD1 Synonym C115779 SOP List

MV 168.CSD1 Synonym C115779 'SOP List'

MV 338.CSD1 Preferred Term C115779 SOP List

MV 562.CSD1 Preferred Term C115779 SOP List

MV 770.CSD1 Synonym

MV 336.CSD1 Synonym C115780 Trial Management Plan




MV 339.CSD1 Abbreviation C115783 Communication Plan

MV 491.CSD1 Definition C115784 Trial Master File



MV 354.CSD1 Definition C16735 'Informed Consent Form'

MV 200.CSD1 Preferred Term C16735 'Informed Consent Form'


C115780 'Trial Management Plan'



C115781 Site Management Communications and Tracking

C115784, C115785 Trial Master File & Electronic Trial Master File

C115785 Electronic Trial Master File

MV 495.CSD1 Concur C20108 Country

MV 713.CSD1 Data Properties C20108 Country

MV 417.CSD1 Data Properties C25164 Date

MV 715.CSD1 Data Properties C25164 Date

MV 722.CSD1 Data Properties C25191 Person Name

MV 728.CSD1 Data Properties C25284 Type

MV 191.CSD1 Definition C25320 'Protocol'

MV 192.CSD1 Definition C25320 'Protocol'

MV 190.CSD1 Synonym C25320 'Protocol'

MV 419.CSD1 General C25341 Location

MV 719.CSD1 Data Properties C25341 Location

MV 716.CSD1 Data Properties C25365 Description

MV 724.CSD1 Data Properties C25683 Source

MV 420.CSD1 General C29862 Process

MV 723.CSD1 Data Properties C29862 Process

MV 572.CSD1 Preferred Term C40988 Case Report Form

MV 197.CSD1 Category Code C40988 'Case Report Form'

MV 196.CSD1 Definition C40988 'Case Report Form'

MV 729.CSD1 Data Properties C42694 Username

MV 718.CSD1 Data Properties C42761 Format

MV 727.CSD1 Data Properties C42774 Title

MV 605.CSD1 Reference C54623 Form FDA 1572

MV 613.CSD1 Concur C70800 IRB-IEC Approval

MV 525.CSD1 Use Case C70800 IRB-IEC Approval

MV 369.CSD1 Preferred Term C70885 Regulatory Submission

MV 584.CSD1 Definition C70885 Regulatory Submission

MV 714.CSD1 Data Properties C73925 Credential

MV 360.CSD1 Definition C79176 Clinical Study Report

MV 219.CSD1 Preferred Term C79189 'Approval'

MV 370.CSD1 Preferred Term C79189 Approval

MV 781.CSD1 Preferred Term C79189 Approval

MV 221.CSD1 Definition C79189 'Approval'

MV 220.CSD1 Synonym C79189 'Approval'

MV 281.CSD1 Synonym C79189 'Approval'

MV 361.CSD1 Preferred Term C79278 Pharmacokinetics Report


MV 418.CSD1 General C80447 Digital Signature

MV 717.CSD1 Data Properties C80447 Digital Signature

MV 807.CSD1 Use C80447 Digital Signature

MV 438.CSD1 Preferred Term C82524 Subject Unblinding Plan

MV 644.CSD1 Preferred Term C82524 Subject Unblinding Plan

MV 292.CSD1 Concur C83082 Study ID

MV 496.CSD1 Concur C83082 Study ID

C79278 'Pharmacokinetics Report'

MV 725.CSD1 Data Properties C83082 Study ID

MV 720.CSD1 Data Properties C93874 Organization

MV 589.CSD1 Concur C97107 Regulatory Report

MV 374.CSD1 Synonym C97107 Regulatory Report

MV 782.CSD1 Synonym C97107 Regulatory Report

S/MV 823.CSD1 Use Case Content Classification System

MV 150.CSD1 Content Type Names Domain Metadata

MV 151.CSD1 Domain Metadata - Definitions Domain Metadata

MV 149.CSD1 Subcategory Names Domain Metadata

MV 161.CSD1

S 308.CSD1 Content Type Use Filenote PTs

MV 232.CSD1 Definition General

MV 411.CSD1 Investigator Site Content Types General

MV 549.CSD1 Missing Content Types General

MV 230.CSD1 Source referenced General

MV 409.CSD1 TMF RM Alignment General

Add PT 'Source Data Verification'?

Excel Row 116, Source Data Verification



















S 311.CSD1 TMF RM Alignment General
















MV 774.CSD1 Trial' vs 'Study' term use General

S 768.CSD1 301 Permanent Redirects (3) General

S 325.CSD1 Archiving Use Cases General

S 217.CSD1 Comment period General

S 66.CSD1 Content Classification System General




S 71.CSD1 Content Type Metadata General

S 306.CSD1 Content Type Use General

S 329.CSD1 Country Code General

S 69.CSD1 General

S 65.CSD1 Document deletion General

S 76.CSD1 General

S 142.CSD1 Document/Content formats General

Cross-study document management

Document Restrictions and Permissions

S 326.CSD1 eTMF Domain General

S 80.CSD1 Field Details General

S 767.CSD1 Hanging paragraphs (12) General

S 73.CSD1 Hash or Checksum used? General

S 766.CSD1 GeneralIncorrect subsectioning (6)

S 147.CSD1 Large Images General

S 72.CSD1 Messaging General

S 541.CSD1 OASIS viability General

S 548.CSD1 Rational General

S 119.CSD1 Record Retention Metadata General

S 62.CSD1 Reference to CareLex General

S 122.CSD1 Review and Update Process General

S 117.CSD1 Site Data Submission General

S 77.CSD1 General

S 118.CSD1 Use Cases General




Translations and Document Relationships

S 78.CSD1 User Name Field General

S 79.CSD1 Versioning General

S 330.CSD1 General

S 757.CSD1 General Figures

S 332.CSD1 Country Code

Versioning- Tracking Documentation

Figures - Normative/Non-Normative? (19)

Investigator Documents Subcategory

MV 317.CSD1 General IRB-IEC documents

MV 321.CSD1 General IRB-IEC documents

MV 540.CSD1 Content Classification System IRB-IEC Documents

S 333.CSD1 Classification of content types IRB-IEC Documents Subcategory

S 307.CSD1 Content Type Use Meeting Material PTs

MV 501.CSD1 Add

MV 734.CSD1 Data Properties

MV 522.CSD1 Subcategories and missing PT

MV 507.CSD1 Add Missing - Investigator Site Files


S 242.CSD1 New Content Type/PT

MV 504.CSD1 Add

Missing - Device Review Committee

Missing - Device Review Committee (TMFRM 238)

Missing - Interim Monitoring and Study Closeout

Missing - Investigators Agreement (Device) (TMFRM 240)

Missing - Monitoring Visit Follow Up Letter

Missing - Monitoring Visit Follow-up Letter

MV 304.CSD1 Add Content Type




MV 499.CSD1 Add Content Type Missing - Risk Management Plan



MV 498.CSD1 Add Content Type Missing - Source Data



MV 286.CSD1 Add Content Type Missing - Source Data Verification

Missing - Monitoring Visit Follow-up Letter (TMFRM 241)

Missing - Monitoring Visit Follow-up Letter (TMFRM 241)

Missing - Report of Prior Investigations

Missing - Report of Prior Investigations (TMFRM 239)

Missing - Risk Management Plan (TMFRM 236)

Missing - Risk Management Plan (TMFRM 236)

Missing - Source Data (TMFRM 235)

Missing - Source Data (TMFRM 235)

MV 608.CSD1 Add

MV 789.CSD1 Use

MV 497.CSD1 Synonym



MV 505.CSD1 Add



MV 535.CSD1 Preferred Terms

Missing - Source Data Verification

Source Data Verification (TMF RM 106)

Missing - Subject Identification Log

Missing - Subject Identification Log (TMFRM 234)

Subject Identification Log (TMFRM 234)

Missing - Technical Design Document

Missing - Technical Design Document (TMFRM 245)

Missing - Technical Design Document (TMFRM 245)

Missing - TMFRM #s 236, 237, 238, 239,240, 245

MV 500.CSD1 Add



MV 503.CSD1 Add

MV 739.CSD1 Data Properties New - CRO Oversight Plan

MV 639.CSD1 Preferred Term New - IP Device Maintenance Log

MV 288.CSD1 Concur New - IP Device Maintence Log

MV 287.CSD1 Concur New - IP Retest and Expiry

MV 638.CSD1 Concur

MV 283.CSD1 Content Type use

Missing - Vendor Management Plan

Missing - Vendor Management Plan (TMFRM 237)

Missing - Vendor Management Plan (TMFRM 237)

Missing -Investigators Agreement (Device)

New - IP Retest and Expiry Document

New - Study Team Curriculum Vitae




MV 790.CSD1 Synonym


OWL 815.CSD1 CareLex reference OWL file

OWL 818.CSD1 Electronic signatures metadata OWL file

OWL 819.CSD1 IANA OWL file





New - Study Team Curriculum Vitae (T104.11.39)

OWL 236.CSD1 Modified_By OWL file

OWL 816.CSD1 User name OWL file

OWL 817.CSD1 UTC vs ISO date modified format OWL file

S 246.CSD1 Reference to TMF RM Page 10, 2nd paragraph

S 331.CSD1 Classification of content types Site Management Category

S 534.CSD1 Source Data Use case

S 212.CSD1 Reserved Terms

S 211.CSD1 Term Source URLs Tables 1, 4, 6

zduplicate 213.CSD1 Duplicate Comment

zduplicate 403.CSD1 Duplicate Comment C115748, C115730


Subject Identification Log (TMF RM 234), Source Data (TMF RM 235)

Table 3 Table 3: Rules for Addition, Modification, Import, and Delete of Metadata Properties

C115681 Data Management Communications and Tracking, C115729, C115742


zduplicate 462.CSD1 Duplicate Comment C115744 Vendor Oversight


zduplicate 742.CSD1 Duplicate Comment duplicate



zduplicate 513.CSD1 Duplicate Comment Duplicate

C115706 IP Documents Communications and Tracking (subcateg), C115727, C115640

C115781 Site Management Communications and Tracking

Comment Submitted [bracketed text is clarification to comment]

<A specific comment or summary of multiple similar comments should be entered here>

The text is not specific enough for an introduction to a global specification of this kind. The specification is specifically for content of the trial master file and NOT the “clinical trial domain”. The conduct of clinical trials creates numerous other data, documents and records – together with the systems that manage those data, documents and records - which are outside the scope of this specification.

Minor - Ignoring the hanging paragraph issue, 1 Introduction has two sentences: ***** [All text is normative unless otherwise labeled] A specification for content classification and content interoperability in the clinical trial domain. ***** If the hanging paragraph is corrected to: 1.1 Introduction The specification still needs more than a one liner as the explanation for the specification. I am relatively familiar with content classification and content interoperability issues but can't decide based on one sentence if I need to read this text or not. Expand the introduction to indicate what specific clinical trial domain is at issue and outline of your solution. It doesn't have to be long 300 to 500 words would be sufficient. Issue: Bug Key: TAB-1045 Minor - A list starts in 1.2 Normative References and its numbering continues in 1.3 Non-Normative References. Issue: Bug Key: TAB-1047

Major - 1.2 Normative References reads in part: ***** [2] OWL 2 Web Ontology Language, Structural Specification and Functional Style Syntax, W3C Recommendation. W3C OWL Specifications. [Online] October 27, 2009. http://www.w3.org/TR/owl2-syntax/#Data_Properties http://www.w3.org/TR/owl2-syntax/#Annotation_Properties ***** That's not a valid citation for OWL2-Syntax. The W3C citation generator advises: ***** OWL2-SYNTAX OWL 2 Web Ontology Language Structural Specification and Functional-Style Syntax (Second Edition) , B. Motik, P. F. Patel-Schneider, B. Parsia, Editors, W3C Recommendation, 11 December 2012, http://www.w3.org/TR/2012/REC-owl2-syntax-20121211/ . Latest version available at http://www.w3.org/TR/owl2-syntax/ . ***** The OWL2-SYNTAX is called a "label" is is used later in your document to cite either that entire document or a part of it. The rest of what I show above is the correct citation for that W3C Recommendation.

Major - The cite given: OWL 2 Web Ontology Language, Structural Specification and Functional Style Syntax, W3C Recommendation. W3C OWL Specifications. [Online] October 27, 2009. http://www.w3.org/TR/owl2-syntax/#Data_Properties http://www.w3.org/TR/owl2-syntax/#Annotation_Properties ***** is incorrect. The correct citation is: ***** OWL 2 Web Ontology Language Structural Specification and Functional-Style Syntax (Second Edition) , B. Motik, P. F. Patel-Schneider, B. Parsia, Editors, W3C Recommendation, 11 December 2012, http://www.w3.org/TR/2012/REC-owl2-syntax-20121211/ . Latest version available at http://www.w3.org/TR/owl2-syntax/ . ***** As per the citation generator at: http://www.w3.org/2002/01/tr-automation/tr-biblio-ui Issue: Bug Key: TAB-1048

Minor - The current draft has two separate list styles in 1.2 Normative References. The first is the common key entry [RFC2119] mixed with a numbered list of references. Issue: Bug Key: TAB-1046

The TMF Reference Model version 2.0 (URL: at DIA EDM Corner) should be added to this reference list since it is also used as a mapping cross-reference in the OASIS eTMF vocabulary list, as stated on page 10.Highly recommend that all document artifacts listed in the TMF RM are assigned a classification in the OASIS eTMF, otherwise documents might be omitted that should be filed in the eTMF, to prevent them from having to be entered later as organization-specific (Sub-) Categories or Content Types.

Non Normative References – 13 are listed however Question: What is the % breakdown of the contributions by participant?

The specification, vocabulary and TC Charter makes reference to the TMF Reference Model. The vocabulary includes specific text that originates from the TMF Reference Model and yet it is not included here as a non-normative reference. Please include for completeness.

Section 1.3: It is not clear of the intention for inclusion of Non-Normative references. Would it be more appropriate to use references that are normalized and adopted across the industry?

There is no reference to or tie-in to the TMF reference model in any place in this document. Since the reference model is a de facto standard, that seems like a huge omission.

Minor - 1.3 Non-Normative References reads in part: ***** Clement Jonquet, Paea LePendu, Sean Falconer, Adrien Coulet, Natalya Noy, Mark Musen, and Nigam Shah. Ontology-based Search and Mining of Biomedical Resources. Semantic Web Challenge 2010 Submission. [Online] 2010. http://www.cs.vu.nl/~pmika/swc/submissions/swc2010_submission_4.pdf, 2010.. ***** The link checker at: http://validator.w3.org/checklink advises: ***** Line: 1337 http://www.cs.vu.nl/~pmika/swc/submissions/swc2010_submission_4.pdf redirected to http://labs.yahoo.com/author/pmika/swc/submissions/swc2010_submission_

Does the problem only relate to on-going/new content – we deal with massive “backlog” projects, often in CRO/Sponsor file structures – would it be work having some mapping from other structures in scope also? (or some generic index values?)

The abbreviation EDMS is more commonly used for “Electronic Document Management System” and not “Enterprise Document Management System”.The problem that this specification addresses is not limited to those with ENTERPRISE Document Management Systems. The problem affects any organization using an ELECTRONIC record-keeping, ELECTRONIC records management or ELECTRONIC document management system for clinical trial documents or records.The examples chosen to demonstrate the problem do not include the most common and most problematic issue facing the clinical trial domain, namely exchange of content between systems e.g. from CRO to sponsor. The ability to conduct searches across distributed sets of trial data is not the principal problem that stakeholders align themselves with.

General comment for section 2: There should be some specific use cases called out here (or elsewhere in this area) that help explain exactly what problem this specification seeks to solve.

Major - Section 1 Introduction reads in part: ***** [All text is normative unless otherwise labeled] ***** Section 2 is not marked as non-normative, therefore I assume it is normative. Incorrectly normative. Section 2 does not set forth any requirements, definitions or other constraints that are referenced by the conformance clauses. It is a general prose description of the reason to have this proposed standard. BTW, you need to fix the hanging paragraph I mentioned in another comment. Issue: Bug Key: TAB-1051

The phrase “as well as preparing content for regulatory submissions” in paragraph 3 of 2.1 is not clear, is often not true and adds ambiguity to the definition of an eTMF. Regulatory submission preparation systems are more commonly completely separate from eTMF so to include this phrase is likely to result on reader confusion.

For many readers, including the vast majority of those outside the US, the term “archive” has a very specific meaning in a regulated environment. An archive is a repository specifically designed for the long-term retention and preservation of documents and records and NOT a pseudonym for a file system or other repository. Whilst an electronic trial master file system may additionally provide appropriate features to be an archive repository too, they are more often 2 separate entities. An electronic trial master file is more usually unlikely to be suitable for retention of trial master file content for periods in excess of 25 years, as required by EU Clinical Trial Regulation 536/2014.

The phrase “clinical trial content” is used incorrectly. This specification is limited to the content of the trial master file and not ALL clinical trial content. Please replace with “clinical trial master file content”.

This standard for the most part does not deal with the format of documents and records, rather the metadata. Therefore inclusion of the phrase “there is no standard that defines how eTMF documents and records should be formatted for electronic export” gives the impression early on in the specification that the document addresses document format, which it does not.

The specification is concerned with the interoperability of eTMF documents and records and NOT with the export of content for regulatory submission purposes. Export formats that meet the requirements of government agencies is a requirement for regulatory submission systems and NOT electronic trial master file systems. To apply this requirement to an eTMF system that may be completely distinct and separate from an organization’s regulatory submission system adds no value. It would of course make sense to ensure an eTMF system is capable of exporting content in a format that was suitable for the organization’s regulatory submission system, but that should not be a prerequisite for an eTMF interoperability standard.

The use of the word “automated” in paragraph 2 of 2.1 is not understood. Please explain what an “automated EDMS” is and how this differs from an “EDMS” or remove the word “automated”.The sentence “For those without access to EDMSs, a method to exchange, view, and navigate content offline is needed” is not understood. The use of an EDMS is unrelated to being online or offline. The issue is simply one of being able to exchange, view and navigate content on electronic repositories containing clinical trial master file content, irrespective of whether those repositories are enterprise systems, EDMSs, Microsoft Access databases or whatever.

Please change “clinical trial domain” in paragraph 3 of 2.1 to “clinical trial master file domain”; this specification is limited in scope to the trial master file only.

Major - Section 1 Introduction reads in part: ***** [All text is normative unless otherwise labeled] ***** Section 3 is not marked as non-normative, therefore I assume it is normative. Incorrectly normative. Section 3 does not set forth any requirements, definitions or other constraints that are referenced by the conformance clauses. It is a general prose description of the reason to have this proposed standard. BTW, you need to fix the hanging paragraph I mentioned in another comment.Issue: Bug Key: TAB-1052

Section 3.1, first sentence "The benefits of implementing interoperable..." This sentence does not seem to add much value, recommend striking

Don’t understand how this model supports eSubmissions – don’t see any mapping to eCTD/RPS

Please change “The high level benefits of a standard for interoperable clinical trial information exchange…” to “The high level benefits of a standard for interoperable clinical trial master file content and metadata exchange…..”. The scope of the standard is limited to the trial master file and not all clinical trial data. The original statement is ambiguous.

The TC should reconsider including as a specific benefit of this standard “Streamline agency compliance with standards-based exports and eSubmissions”. In a global environment, it is a potentially a dangerous statement that agency compliance will follow adoption of this standard for eTMFs.

What feature enables this [data exchange]? [Enhance clinical trial safety and efficacy with serious adverse event data exchange]

Section 1 Introduction reads in part: ***** [All text is normative unless otherwise labeled] ***** Section 4 is not marked as non-normative, therefore I assume it is normative. But Section 4 mixes normative and non-normative text without warning. For example, 4.1 starts: ***** The key OASIS eTMF foundational layers, as illustrated in Figure 1, include a Content Classification System (CCS) layer to automate content classification; a Vocabulary for Content Management Layer to describe classifications and documents through published vocabulary; and a Web Standard Technology Core Layer, which includes W3C standards for information discovery and exchange in addition to support for electronic and digital signatures and business process models that reduce paper handling processes. ***** A general description and includes a part not written by the TC, the W3C standards. The rest of 4 continues with general descriptive language. Nothing wrong with general descriptive language in a standard but it isn't normative. Issue: Bug Key: TAB-1064

Section 4 – Core Technology - Page 10 - A sponsor and a CRO may use a different term to represent the same content in an eTMF. This is usually driven by the sponsor so that the same term is being used consistently and so there isn’t any confusion when it is time to submit the document as part of an application. Does the term appear as a title or document name when the document is used in a submission, given that naming convention standards have to be adhered to? Are we saying at the end of the day the Standard Metadata Vocabulary is what is ultimately submitted to an agency and if so why not use that vocabulary from cradle to grave? Does this approach streamline and eliminate the need to cross-reference terms from various entities.

Minor - In section 4.1: "...Details of this layer are discussed in Section 5, “Content Classification System” on page 10." Should not refer to page numbers. Page 10 has in fact no reference to CCS - I guess it is now page 11. Section # is sufficient for local refs. Issue: Bug Key: TAB-1054

“The DIA TMF RM provides a set of terms for the industry through its published spreadsheet.” The TMF RM is more than just a set of terms. Through its use of zone, section and artifact hierarchy, it provides a taxonomy for trial master file content. Suggestion: “The DIA TMF RM provides a set of terms and taxonomy for the industry through its published spreadsheet”.

The following statement is misleading: “healthcare and life sciences standards organizations such as HL7, CDISC, FDA, NIH and others”. FDA and NIH are not standards organizations. Please re-word. Suggestion: “healthcare and life sciences standards organizations such as HL7, CDISC and other healthcare/life sciences organization such as FDA, NIH and others”

Section 4.1 Description of the ArchitectureGeneral comment: There seem to be inconsistencies in terms used in this section that define different 'layers'...makes it difficult to understand. For example, what is the "presentation layer" (bottom of page 9)? There is no mention of such a layer previously in this section. Please define or use a consistent term.

“This layer is based upon the W3C RDF/XML, which represents resources through the web, can be easily searchable, widely used, and allows sharing electronic information through the cloud.” This sentence does not make sense grammatically (e.g. “can be easily searchable”). In addition, adoption of the standard will not limit sharing electronic information vis “the cloud” only; this is confirmed in Section 2. Use of the term “the cloud” adds no value and introduced ambiguity.

Question- How is clinical trial development time lines accelerated with interoperability exchange?

Page 11- MVI [Metadata Vocab Interoperability?] What industry groups are identified? Frequency and conflict resolution need to be addressed.

“”…providing a path forward to a global ISO standard…”. The development of an OASIS standard to an ISO standard is outside the scope and remit of the OASIS TC and is not described within the scope and objectives of this draft specification. Please remove this reference to a global ISO standard for eTMF interoperability.

“….for a specific domain (e.g., eTMF)”. The specification concerns only one domain, namely eTMF. Therefore “e.g.” is not an appropriate term in this context. Suggestion: “for a specific domain (i.e., eTMF)”

Major - Section 1 Introduction reads in part: ***** [All text is normative unless otherwise labeled] ***** Section 5 is not marked as non-normative, therefore I assume it is normative. But it consists of a mixture of possibly normative and certainly non-normative text. For example: ***** Similar to how the Dewey Decimal system is based on the Universal Decimal Classification System To maximize machine readability, the classification and numbering scheme is based on the W3C XML naming conventions. In this naming convention, only simple text is allowed for category naming and numbering, and special characters, such as ( ) *$ @ ! and others are prohibited. [mis-statement of the XML naming rule] The classification categories component contains classification entities, such as Further details about Annotation Properties are provided in the Appendix. [which appendix?] Typically, a Content Type ID number single archive would typically contain entered by the user and a Category Code and a machine-readable unique Term Code are generated locally in a way that ensures the classification numbering format is followed and no conflicts exist in the classification hierarchy. [implementation level details?] All MP3 files today contain standard tags or metadata, such as Artist, Title, Album, and Genre that are embedded in the MP3 file to enable rapid electronic classification and search. ***** Those are just a few of the statement in section 5 that I could not advise someone on how to implement them. How does someone implement "typically?" There are numerous issues with this section and it should be re-written to distinguish normative from non-normative text. Issue: Bug Key: TAB-1065

Can a single content file be associated with multiple documents within a study or across studies?

Section 5 Does the Primary Category, Sub-Category and Content type level map to the Zone, Section and Artifact level of the DIA Reference Model? Would it be helpful to create a standard of minimum metadata that has to be added for each content type an piece of content based on published guidance to ensure interoperability, but then allow organizations to add any additional metadata they want as long as they meet the minimum standards for interoperability?The three digit numbers used by the DIA Reference model are unique identifiers for individual artifacts. This is in addition to having a 2 digit id for each artifact within a section. Is the content type in OASIS equivalent to an artifact vs. a type of document eg, TMF Trial level document, TMF Country level document or TMF Site level document? Section 5.2 would suggest not, but 5.3 suggests this is the case.

Page 10- How are CCS and MVI updated? Who is responsible and what is the frequency? How do we ensure version control among users?

Re: Images and reports: Images are usually source data kept only in the Investigator's On-Site Trial File, but anonymous copies are sometimes filed in the sponsor's TMF, depending on the trial design and events. Using a Content Sub-Type classification could be useful here as well, e.g. C115642-Category "Centralized Testing" (Suggest renaming, e.g. to "Bioanalytical Testing and Examinations")/ Subcategory C115645-Subcategory Facility Documentation" / Content Type C115573 "Bioanalytical Reports" (suggest renaming, e.g. to "Results and Reports") / New: Content Subtypes: Report-Laboratory Results, Report-Histology, Report-Hospital, Image-Digital Photos, Report-Digital Photos, Image-Radiography, Report-Radiography, etc.

Section 5.1 : Content Type: definition of content type of the documnet is correct however Content Type in this section refers more to an individual artiifact. Suggest use of Artifact Type.

The Primary Categories in the eTMF domain are numbered from 100 – 199, providing 100 primary category divisions. Seems to be too much granularity – too many primary categories could make it less intuitive / harder to maintain eTMF oversight. In the eTMF Vocabulary List, only 100 – 111 have been used. If 112 – 199 are not needed, suggest to assign primary categories in a more intuitive way which would parallel the eTMFs already in use in the industry based on the TMFRM, e.g. 100, 200,…110 (analogous to TMF RM zones 1 – 11).

Critical - In 5.1: "The classification categories component format is based on the Universal Decimal Classification System (UDC), " The UDC plays a significant role in this CCS, in a normative way. Inappropriate reference to Wikipedia. This is a normative reference, please use a more formal and stable source and more conventional citation format (reference section). Wikipedia should not be used in a normative way. Issue: Bug Key: TAB-1055

The proposed classification schema, including content entities, hierarchy and numbering system are all helpful to promote and facilitate standardization of content across eTMF technologies. However, this level of complexity is unnecessary SOLELY for interoperability and data exchange, which is the remit of this OASIS Technical Committee and specification. The specification provides for a unique Category Code, representing an artifact, document, record or data item described in the NCI Thesaurus Enterprise Vocabulary Services. The inclusion of Primary Category, Subcategory and Content Type – whilst giving semblance of alignment with the TMF Reference Model and encouraging standardization of indexing – is unnecessary for interoperability and content exchange and adds unnecessary complication. Furthermore, it may prevent vendors that currently have an eTMF data model that does not include this approach from adopting the standard i.e. it introduced an unnecessary barrier. For example:A “Trial Team Member CV” needs only to be characterized using the classification code C115489. The category code T100.11.11 is not necessary for data exchange, neither is the Primary Category (Trial Management), Subcategory (Trial Team) or Content Type (Trial Team Member CV). If an artifact with classification code C115489 is exported from System A to System B, the import API of System B will know how to manage the object by virtue of the fact that it has classification code C115489 i.e. it will be handled as a Trial Team Member CV. This allows for complete flexibility of eTMF taxonomy by allowing vendors to choose any approach for content entities and hierarchy. Implementation of the full proposed content entities, hierarchy and numbering system could present a significant barrier to adoption for many eTMF solution and should therefore be avoided in a global standard unless it is critical to the objective of the specification (interoperability and exchange). Only a unique content identifier is critical for interoperability and exchange, together with a standard interpretation of the identifier, as provided for by NCI.

Do these [ Primary Categories in the eTMF domain] correspond to reference model zones? Would be helpful to call this out.

Define content entities

Section 5.1. Category_Code for category and sub-category doesn’t start with T. However, category_code for content types does start with T. what does T mean? Will there be another letter besides ‘T’?

Section 5.1 "It allows for automated sorting..."If all classifications are numbered in this way, the need for a standard vocabulary or text-based term seems only so that humans can discuss the classifications. If this is the case, why not use the TMF RM terms as the starting point?

In section 5.1, the term “Content types” sounds misleading. It also mixed up with “Content type” term in SharePoint system. Suggest we call it “Artifact Type”.

Major - In section 5.1.1: "Each Classification entity contains at least the following annotation properties:" What is an Classification entity? Never seen this term before. Issue: Bug Key: TAB-1056

Section 5.1.1.2 "Category Name, which is used...for compliance with other standards" What other standards prescribe use of specific category names? Suggest adding a standards reference here.

The description of the sub-categories concept is a bit confusing, and is not reflected in the Vocabulary List. As I understand it, the description implies there can be both primary and secondary subcategories, and up to 5 additional (sub-) sub-categories can be assigned within a sub-category, which might become a potential source of classification error, if this results in sub-categories that have the same numbering code as the Content Types (with the exception of "T" in front of the sub-category number), e.g. as in the example "142.23.67".Suggest that either the definitions on page 12 need to be rephrased, or that a simpler structure be considered for the OASIS eTMF, e.g. "Category / Sub-category / Content Type" analogous to the TMFRM "Zone / Section / Artifact" structure to avoid complicated search and retrieval of documents (Latter Section 5.1.1.2: "The Classification System follows a naming scheme that combines the classification hierarchy name (i.e., Category Code, which is designed to automate document classification and locate the category in the content model hierarchy) and the simple text-based name (i.e., Category Name, which is used in the OASIS eTMF model for compliance with other standards)" What other standards use Category Names?

Section 5.1.1.2 "second part 'Trial Management'"Isn't the category name for this category code "Trial Operations"? Figure 6 does not match this text nor the vocabulary worksheet

5.1.1.2 Classification Categories Naming Scheme, Line 5 In Figure 7 Trial Management is shown as 100, In line 5 Trial Management is referred to as 100.10

As previously stated, a taxonomy with standardized category naming is not essential for eTMF interoperability and content exchange. It provides unnecessary complexity and limits the flexibility for eTMF solution developers/vendors. Interoperability only requires a standardized and unique content classification code or ID.

Section 5.1.1.2 "Numbers for sub-categories start..."I believe the nesting and division schemes requires further clarification. Its unclear to me why the example 142.23.67 is valid.

Major - Section 5.1.1.2: Because this classification scheme borrows heavily to UDC, this section should make clear what is specific to eTMF and what is not. Am I reading a digest of UDC? Or something that the eTMF TC created? Or both? The specification should be clear about this. Issue: Bug Key:TAB-1057

In Figure 9, the example "Trial Team CV" is classified as both a Subcategory (100.11.10) and a Content Type (T100.11.10.11), which seems redundant. However, in the Vocabulary List "Trial Team CV" is classified appropriately only as a Content Type (not as a subcategory) with number T100.11.11. Please review / revise the example in Figure 9.

Section 5.1.1.4 "In the first case, the details of an Organization-specific..." Is the creation of organization-specific categories or content types really necessary scope? It seems counter to the purpose of this specification.

Section 5.1.1.4 "In the second case, the Domain-specific..."Explanation of new domain-specific categories or content types could use some clarification - particularly an example for what is referred to as a 'Content Model'.

Major - In 5.1.1.4: There is no clear definition of what is an Organization, what is a Domain. The definitions for "Organization-specific" and "Domain-specific" are only found in an unlikely place (Appendix B.2), where we learn that these are "metadata types". That should be made clear much earlier. Or there should be clear pointer to their definitions. The reader is left in the dark until reaching the very end of the document. Issue: Bug Key: TAB-1058

Given that the taxonomy and vocabulary is based upon international, published regulatory requirements for clinical trial master file content, uses the NCI vocabulary, AND provides for the use of optional labels and other metadata to describe documents and records, the ability for an organization to add their own Categories, Subcategories and Content Types is considered unnecessary, undesirable and contrary to the objectives of an interoperability standard. Where a gap in the Categories, Subcategories and Content Types provided within the specification is identified by industry over time, the specification/standard should be revised accordingly to bridge the gap and so ensure ongoing interoperability and standardization. This is the approach adopted successfully by the TMF Reference Model where multiple individual organization-specific documents can be mapped to entities within the TMF Reference Model (artifacts) but the underlying taxonomy remains constant.

“These codes should have the ‘Z’ prefix as illustrated in Table 1.” Table 1 does not appear to show how the ‘Z’ prefix is used.

Page 15 Original code for categories and context types must be maintained along with abbreviated names. Does it have to convert to original code and category for interoperability – maintaining both? How is this archived?

It is not understood from the text provided how allowing Organization 1 and Organization 2 to add their own organization-specific Categories, Subcategories and Content Types, each with completely numbers to identify them, will facilitate interoperability between those 2 organizations. Interoperability, in this scenario, would only be possible after a manual mapping of the content types between the two organizations…. a scenario that this specification is aiming to avoid.

Page 14 Classification categories – has this been compared to large global trials that break down information by region/country?

Page 16 Organization specific classification and content is not easily handled with interoperability. Importing party is responsible for checking? Is there a standard process defined as well?

Per section 5.2, is there a metadata property indicates the milestone of the study ,country or a particular investigation site?

Section 5.2.1 (page 18) "Data Properties are...without explicit relationships defined" Are metadata items precluded from having relationships to one another (such as Study & Study Site)?

Section 5.2.1 "Every digital document..."Is "digital content item" used interchangeably with "digital document" and "computer file" throughout? If this assumption is not explicitly stated anywhere, it would help to do so, or to use one consistent term throughout.

Section 5.2.1.1 2nd paragraph, "...included with every entity term""entity term" is used here for the first time. It would help to define and/or provide example(s).

Section 5.2.1: Digital Content item, digital document and computer file - so they all refer to the same thing. If so please use one that is commonly used term.

“If every organization uses different metadata terms (as shown in Figure 12),”. The text should reference ‘Figure 11’ rather than ‘Figure 12’.

In this section, the rationale for avoiding use of dissimilar metadata is to “enable efficient global search, reporting, and classification of documents within and outside of an organization”. Given that the primary objective is interoperability and content exchange, it would be more appropriate to cite this as the rationale for avoiding dissimilar metadata terms rather than efficiency and productivity.

Four categories of metadata are introduced in this section but the 2nd and 3rd are combined into a single section within the bulleted list. It would be clearer for each category to be listed against a separate bullet.

Section 5.2.1 "In the context of a Content Management System.."In the introductory section of this document, it was stated at EDMS systems were currently used. Suggest being consistent here, or updating the introductory section.

Page 20- Organization specific metadata is not added. If the organization information is added, then what metadata is included?

I am understanding this correctly that there are a set of definitions for eTMF content that are only available in this format and not published in document format? This will in general prevent business users (the primary stakeholders of this information) from effectively reviewing it. [Data Properties highlighted with this comment]

Major - Section 5.3.1 Content Model Format reads in part: ***** The OASIS eTMF content models are created and published as ontologies based on the W3C’s OWL 2.0 syntax and RDF/XML. ***** Well, the OWL document mis-cited under 1.2 starts by saying: ***** This document defines the OWL 2 language. The core part of this specification — called the structural specification — is independent of the concrete exchange syntaxes for OWL 2 ontologies. ***** First of all, there is no normative citation to RDF syntax, the syntax that is being used by the TC to represent its OWL ontology for interchange. Second, there appears to be confusion on the TC about OWL and RDF and their respective roles in ontology work. One does not imply the other. Nor are those terms interchangeable. Issue: Bug Key: TAB-1050

If a sponsor and CRO are both maintaining eTMFs for the same trial and the sponsor wants to merge, what would prevent them from duplicating those documents they had issued to the CRO. E.g.: sponsor creates protocol and files in their own eTMF, also issues to CRO. At end of trial CRO delivers a set of documents that includes that protocol.eTMFs contain documents of formats other than PDF. Part 11 does not dictate specific file formats. [XML and PDF highlighted in line 6 of paragraph]

6.1 Page 26 There are more file types than XML and PDF. How do we handle images such as DICOM, MP3 (audio training files), or MP4 (video training and or procedure files).

Section 6.1 : “For FDA part 11 compliance, the eTMF electronic archives can be exported using common file formats of XML and PDF”, Part 11 Compliance does not specify the export format to my knowledge. Please check this or remnove this.

This section (4th sentence) implies that export to XML and PDF is required for 21CFR11 compliance. My understanding is that the requirement from the FDA is not a requirement contained within the Code of Federal Regulations Chapter 21, part 11. Furthermore, the requirement pertains ONLY to content that is required to be submitted to the FDA electronically as part of a submission. The statement is therefore misleading. In addition, it is not understood why requirements of the FDA are specifically cited within this draft specification when it is intended to be a global standard.

Page 9- Question: How is SAE exchange supported?

From the first sentence “The OASIS eTMF data model represents a single instance of an eTMF content model for a single clinical trial.”, it is not clear whether there can only exist one content model for a single clinical trial. On any given clinical trial – especially long-term trials – it may be necessary to revise the content model, for example, to change an object label. There would therefore exist more than one content model for a given clinical trial.

Section 6.1 "Per FDA part 11 compliance..." I am not aware of any export formats required by 21 CFR 11. Suggest striking this phrase.

Page 9 Question: – Agency compliance in USA is eCTD, how is this supported? The documentation states that a yes/no is applied to the data items, however this is not a supported export.

6.1.1 Page 26 Identification of eCTD data items as yes/no, does not address the need for eCTD format exports in the USA. What is the plan for an eCTD format within OASIS interoperability?

The FDA requirement for specific file formats for the Common Technical Document (eCTD) is not understood to be a requirement documented in Code of Federal Regulations Chapter 21, part 11 but simply an FDA requirement for eCTD submission. It is not understood why FDA-specific regulatory requirements have been cited to the exclusion of requirements from other global regulatory agencies in this global specification / standard.

I don’t see any mechanism to handle both primary content (such as MS Office or image formats) AND PDF renditions. It is generally desirable to exchange both.

6.1.1. OASIS eTMF Data Model Exchange Format, Figure 17, Data Model Inputs How come DIA TMF RM is not mentioned?

What folder taxonomy? Is this dictated? [Line 1 of 1st paragraph]

Major -Section 6.1.1 reads in part: ***** The OASIS eTMF data model primary exchange file format is the RDF/XML. The file includes core and organization specific Categories and Content Types (reserved and in use), annotation properties, metadata properties, and links to instance resource content items offline and online (linked data). Content item name is unspecified and the content item file format is any supported IANA media type format [1]. To allow exporting content items that use the electronic Common Technical Document (eCTD) compatible file formats (for FDA Part 11 compliance), a metadata term called eCTD Item tags eCTD docs/records (tag value is true or false). This format enables the interoperable exchange of content models, content items from cloud or physical media, metadata terms, and metadata values for clinical trial study instances between systems and applications. Exported records are in XML format and no specific format for content items is specified. ***** I'm not real sure what I should say. XML file formats can, with proper mappings support interchange. But interchange of XML files, different XML files, is a non-trivial issue. In fact for some XML file formats it is a research issue. I think you need to import some XML expertise before producing another draft. BTW, are you aware that IANA MIME types number 1,470 as of 4 August 2014? Expecting every application to accept all 1,470 is a bit much.Issue: Bug Key: TAB-1067

Whilst the exchange of content between systems as a collection of folders via a standard ZIP file may be appropriate in some use cases, the draft specification does not appear to accommodate the more usual use case required by industry, namely the on-going, real-time exchange of content between eTMF systems e.g. from CRO eTMF to sponsor eTMF, or from investigator site eTMF (eISF) to sponsor eTMF. Exchange via ZIP files in these scenarios is not a practical approach. As a general comment, the draft specification does not appear to address anywhere the typical use cases that the standard is expected to operate within. The use of ZIP compression software is not universally accepted in regulated environments as it is often very difficult to validate the end-to-end process (there being many different “flavours” of compression and decompression tools).

Page 27 Define OASIS folder taxonomy? Who controls it? Who updates it? What is the review process and the frequency?

To be used for certain purposes. [4th paragraph, 'directive' highlighted]

The statement “However, the signing party cannot be easily verified.” should be qualified. The signing party for a simple electronic signature can usually be verified very easily so long as content is maintained within the source eTMF application or so long as the identity of the signer is exported with the content (as required by 21CFR11 § 11.50 and § 11.70). Any electronic signature that does not include the printed name of the signer or that can be excised from the content to which it was applied, does not comply with the requirements of 21CFR11. The original statement is therefore ambiguous and possibly misleading.

This is not quite accurate. The digital certificates apply only to signatures in certain forms that are issued by the EMA, not to any signed documents in the submission. [see end of 3rd paragraph:...'for three types of submissions: orphan medicines, pediatric submissions, and scientific advice.' highlighted]

Not sure I understand. Formats such as xpt cannot be signed by any technology I am aware of, but are accepted by FDA. [7th paragraph, 'any file format approved by FDA and EU is supported for e-signing.' highlighted]

6.2- Page 27/28 The current document addresses digital signatures, but not electronic. How does the standard address electronic signatures and or wet signatures scanned (corresponding metadata).Electronic signatures are user/password protected, so they are verified in the system it is not 2 factor verification. If the industry standardizes on a 2 factor signature verification, the cost of implementation and maintenance is extensive. This would dilute the initial statement that standards would The content of this section (Electronic and Digital Signatures) is not considered to be sufficiently detailed to facilitate interoperability of electronic signatures between eTMF solutions or to exchange eTMF content whilst maintaining the integrity and compliance of those signatures. As an absolute minimum, I would expect the core metadata to require the three specific attributes mandated by 21CFR11, namely (1) the printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. Furthermore, given the emphasis within the specification regarding compliance with the FDA’s export requirement for eCTD purposes, there should be an explanation of how digital signatures apply in this scenario. For example, the digital signature applied to a Microsoft Word document would be invalidated when exported to PDF v1.4. Currently, the specification does not describe use of electronic or digital signatures to a level necessary to facilitate interoperability.

Please provide full meaning of the abbreviation ‘RSA’.

The statement “In the context of the OASIS eTMF standard content model, digital certificates are issued to individuals to sign electronic documents” is not always true. An alternative use case is for an individual to sign a document using a simple electronic signature, which is then certified (locked) using an organizational digital certificate. The digital certificate provides authentication that the document was electronically signed within the specified organization and provides for a single digital certificate to be used (purchased) rather than assigning a separate digital certificate to every user. The statement “digital signers are validated every time they sign” should be qualified. The requirement to validate on each signing activity is not inherent in the technology. Many digital signing solutions do not require use of a password out-of-the-box and/or allow the user to turn off the requirement to enter credentials again within a specific time period.

Page 35 – Electronic signatures are not defined yet dominant in the industry compared to 2 factor signatures. How do we handle this in the interim until industry transformation occurs? Comment: It is not being properly addressed as it is pushing a digital signature strategy.

Section 6.2: Suggest revising the statement: ‘Electronic and digital signatures enable the removal of wet signatures on paper’ to ‘Eliminates the need for a document created electronically to be converted to paper to be signed with wet ink’

Section 6.2 : “However, the signing party cannot be easily verified.” This is not needed here. FDA/EMA recognized both digital and electronic signatures. It just shows bias towards digital signatures.

In section 6.2, it talks about electronic and digital signature. So what kind of information should be captured by signature? Person, reason, datetime stamp? And if so, how to represent those information in the xml format for data exchange especially for electronic signature?

Section 6.2 "However, the signing party cannot be easily verified"This is too subjective a statement and should be removed, or added to to qualify under what conditions an electronic signature's signing party cannot be easily verified. If this is true, why does FDA accept them per 21 CFR 11?

Section 6.2 "RSA or Elliptic Curve" Are these terms defined or given a reference anywhere in the specification? If not they should be.

Major -Clearly 6.2 Electronic and Digital Signatures as well as 6.3 Business Process Model are non-normative but not marked as such. The TC has not defined any normative requirements for either area and so cannot be writing normative text about either one. Issue: Bug Key: TAB-1068

6.3 Page 28 – What if there are multiple status steps within the work flow such as multiple approvals? How is this handled?Currently we support multiple status changes to accommodate work flow – OASIS needs to address this as it would need to capture the process change in order to understand hierarchy and how to implement the standard.

Having a section on Business Process Model doesn’t seem to align with the purpose of this document. If there is to be guidance and direction around a business process then it is suggested to create a separate document purely for Business Process. Although, it is not clear how much standardisation can be obtained from this. Additionally, this section is mapped to a non-normative technical standard by OMG. Suggest defining Universal Standards for minimum business process requirements consistent across the industry.

Section 6.3 "...Source, Digital Signature, and Date"Digital signature only? Or should this be Electronic Signature? If digital only, why does the BPM metadata not support electronic signatures?

Column I, row 116 Source Data Verification. This is information is included in the monitoring visit report. Consider deleting.

The [TC] have provided a very detailed vocabulary and taxonomy for eTMF content. It is therefore very surprising that whilst a framework for use of business process is provided no attempt appears to have been made to apply standardization to ensure interoperability. The eTMF domain generally uses a limited set of processes and tasks that apply to documents and records, It would therefore be reasonable to expect the TC to recommend a vocabulary that ensures consistency in terminology and which allows for interoperability. For example, is task “Review Complete” in Organization 1 the same or equivalent to “Document approved” in Organization 2? Is “QC Complete” in Organization 1 the same as “QC Complete” in Organization 2? It is vital that the meaning of tasks and processes used by disparate organizations are properly understood. I recommend adding eTMF domain-relevant processes and tasks to the vocabulary, including the meaning of each process and task and a unique ID for each process and task.

In general, I don’t understand the value of exchanging this information. All required actions against the document should be captured in the audit trail ['Business Process Model' highlighted]

Minor - In conformance clause: "...if the implementation meets the conditions in section 1.1:" Sorry but there are now two Sections 1.1 in this specification. Issue: Bug Key: TAB-1060 [see Section 7, first line and Section 1]

Critical - In the conformance clause: "b) Conforms to specifications detailed in the OASIS eTMF Metadata Vocabulary Interoperability Layer, and sources core classification terms from the published OASIS eTMF Standard Ontology, based on terms published at the National Cancer Institute’s NCI Thesaurus term repository." - Where is the normative reference to this?. Because this shows-up in a conformance clause, there should be a normative reference. Ideally this should be introduced before the clause. Is it clear for an implementer how to conform to NCI? Also: "..I. Supports content exchange through the RDF/XML based data model component" Where are the normative refs to RDF/XML ? Do we need to be more specific what "support" means? Also: "...II. Supports FDA and EMA acceptable electronic " Where are the Normative refs to these standards? Do we need to be more specific what "support" means? The details of all the above should ideally be introduced outside the conformance clause (e.g. normative "binding" section, etc.) , especially if these are major external work used in combination with eTMF. Then referred by the conformance clause. Issue: Bug Key: TAB-1062

In (d) of Conformance clause: "d) If the eTMF Content Classification System is used for any application where ‘individually identifiable health information’ is captured, stored or transmitted..." It is not for a conformance clause to speculate on what is the intent of use of the CCS. The conformance clause is only concerned with what conditions the CCS must meet to conform to this spec in some way, regardless of its context of use. It should not depend on this context. It is up to an outside authority to judge under which circumstances the usage conditions mandate conformance of an implementation to Clause A,B or C. In other words, the "if..." part of (d) and (e) should not show in any conformance clause (or should just be an informal annotation - not a formal condition that impacts how to read the clause). Instead: - make all the clause material before (d) and (e) a clause that defines "core" conformance to eTMF, independent from these particular domains.. - Make a separate clause for (d) called "HIPAA-eTMF-conformance" that builds on “core”. This new clause will just say: (a) must conform to “core” , (b) MUST implement US Department of Health and Human Services HIPAA privacy regulations and compliance policies for electronic records and patient protected health information (PHI) security (whatever that means - may need to be more explicit here !) - same for (e): Make it a third clause called "clinical-FDA-eTMF" conformance. Then define it as: (a) must conform to “core” , (b) the system must adhere to applicable FDA regulations such as 21 CFR Part 11 or other related agency regulations (whatever that means - may need to be more explicit here !) Then leave it to outsiders to decide which conformance level is needed and when, from a system, i.e. which conformance clause should be used given the context of use: - some regulatory body will just ask for "core" conformance. (clause #1) - some Health related body will require "HIPAA"-level conformance (Clause #2) given their context of operations. - some other regulatory body will require "clinical-FDA" level conformance (clause #3) given their operation for clinical trials. Issue: Bug Key: TAB-1063

Major - Section 7: "...An implementation is a conforming eTMF Content Classification System if it..." It is not quite clear what kind of implementation is supposed to conform. In other words, if I were to write a test procedure based on that conformance clause to verify conformance, what kind of entity would I be supposed to test in practice? Or: What kind of part of the real world qualifies as a “candidate implementation”? Is an [candidate] implementation: (1) an actual set of “formatted annotations” (to be mapped to real world documents)? Does it include a particular metadata set? An ontology” What is optional in the above list? In other words, Is a candidate implementation a particular concrete definition of what we call a Content Classification System, in a generic way? (which may or may not conform to eTMF) But then such an implementation cannot be judged w/r to the “rules” in 5.2.2.1 : these rules only apply once the classification system is actively deployed and evolving – not just to its definition. It does not make sense to ask an implementation that is just a definition as in (1) to conform to rules on how to evolve this definition. (2) So should a "candidate implementation" of eTMF also include the actual lifecycle of a deployed classification system? E.g. the procedures in a library XYZ for adding new elements, modify them etc., which may or may not follow the eTMF “rules”. Then only it makes sense to claim conformance to the “rules” for such an implementation. In that case the implementation we are talking about is a combination {Classification System + maintenance and evolution process} that you could call a "deployed CCS". What constitutes an implementation for eTMF should be characterized early on. Ideally as a part of the real world (e.g. set of classification definitions + its evolution process...) that is in itself not too dependent on eTMF, i.e. that may or may not conform to eTMF. Then the conformance clause can target more precisely a type of implementation:: "A <here the name for this kind of implementation, e.g. 'deployed Content Classification System'> is a conforming eTMF implementation if..." Note there may be several kinds of implementations, each having its own conformance clause. Issue: Bug Key: TAB-1059

“An implementation is a conforming eTMF Content Classification System if the implementation meets the conditions in section 1.1:1.1 Conformance as an eTMF Content Classification System” These initial 2 lines are completely redundant as the meaning is repeated immediately following these 2 lines, followed by the conditions for conformance.

The inclusion of section (d) is irrelevant from a content interoperability perspective. eTMF solutions may be required to have an extensive list of functionality to comply with numerous global regulatory requirements (including but not limited to this very US-centric legislation) but these are not needed within this specification. The inclusion of the requirement to comply with US Code of Federal Regulations Chapter 21 part 11 for records which may be submitted to the FDA is not necessary and is irrelevant from a content interoperability perspective. Furthermore, the citation of a US-specific law in a global OASIS standard is not appropriate unless all equivalent laws and regulations in other applicable jurisdictions are also included.

Critical - This conformance clause does not refer in a precise enough way to the normative content in this specification, e.g. using section or subsection numbers. I see a vague reference to "the OASIS eTMF Content Classification System (CCS) Layer" but it is not clear what are the boundaries of this notion in the document - there is no section with that name. Also what are these “CSS specifications” mentioned in (a)? First time this term shows up is in the conformance clause. There should be a normative reference to these, if there is a precise external CCS specification. I also read: "III. Includes Core Metadata as property tags for all content classified in the system" but the term "property tag" never appears anywhere outside this clause. How should I interpret it? As a result, as a developer/implementer/deployer, it is not clear to me which sections must be complied with and how. Issue: Bug Key: TAB-1061

Core metadata currently includes country. This does not apply to all documents. ['system' highlighted]

Please include ‘Trial Master File’ with the ICH definition.

Please provide an alternative citation for NCO other than Wikipedia.

Given that this is the first public review of the draft specification, it is not understood why individuals and organizations who are not members of the OASIS eTMF Technical Committee are being acknowledged for their input. Were non-TC members asked to contribute to the draft specification? If so, why was the TMF Reference Model community not asked similarly to contribute formally to the TC as a non-OASIS member? It appears that Kerstin Forsberg (not a member of the TC, I understand) was asked to review the Definition of eTMF Is a wiki-reference valid?Consider to align with authorities, i.e. from EMA reflection paper:A TMF is the collection of documentation that allows the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated. The requirement for a TMF is set down in Directive 2001/20/ECi Article 15(5) and the TMF forms the basis for inspection (Directive 2005/28/ECii Article 16). The TMF is used by auditors and inspectors to assess the compliance of the trial with legalisation and guidance and by sponsors, monitors and investigators for the management of the trial (Recommendations on the content of the trial master file and archiving iii Section 3 and Note for Guidance on Good Clinical Practice CPMP/ICH5/135/95iv Section 8.1).

There does not appear to be any rationale for including a definition of EDMS that originates from the State of North Dakota. In addition, whilst they appear to have defined “Electronic” DMS, the web page cited is headed “Enterprise” DMS. This ambiguity is likely to cause confusion. It is recommended that a definition is included that originate from a source relevant to the topic, for example a Document Management ISO standard. The definition provides does not actually include the word “document”!

The definition of eTMF appears to limit the scope only to “pharmaceutical clinical trials”. Wikipedia is not a suitable source for an authoritative specification such as this. It is recommended that a definition be provided based on a specific regulatory agency definition.

The eCTD is not an FDA specification. The eCTD is a global specification produced by ICH, applicable to all ICH agencies. Please provide the ICH citation rather than a US-centric citation.

How can Business Process metadata be core?

How can this be core metadata? It does not apply to every document

Should be referencing ICH requirements instead of or at least in addition to FDA

These references are a bit sketchy. North Dakota IT Department and Wikipedia?

Is this a user name or a full name [...who brought the item into 'existence' highlighted].

This section is completely unclear. Is it intended to capture an entire workflow history that was performed for a document, which would have to be repeating? if so, this is captured in the audit trail and not normally as metadata. Don’t see the benefit.

What if a document satisfies multiple content type names (e.g. IRB Member List and IRB Charter? Is this to be treated as one document or two?

How do you relate multiple versions of documents received over time? Do they have the same ID and different versions, or different IDs? How do these map to commonly used terms such as Object ID (specific document ID) and Chronicle ID (version tree ID)

Including metatdata or just content? [...the resource was last 'modified.' highligted]

Most EDMS use a commercial framework (DTCM, Alfresco, SharePoint) and are not able to modify to suit [...regarding the document versioning 'policies' highlighted .

Needs to be date and time, including a time zone or UTC reference [Date of signing 'event' highlighted]

FDA requires “meaning of signature” ['Task associated with the document, such as Signed, Approved, Declined, 'etc' highlighted].

It is uncommon to capture this as most repositories would assume that this is the owner of the repository. It is not a regulatory requirement ['document' highlighted]

Is this intended to be a user name or a full name? ['linked' highlighted]

Does not handle the exchange of a document audit trail. The audit trail captured in the original application must be retained for the lifetime of the record. Without retaining the audit trail, an organization will not be part 11 compliant.

It is not understood why Business Process, together with the associated terms, is categorised as Core Metadata i.e. applicable to every content item. It is agreed that where Business Process is used, there needs to be a common standard to facilitate data exchange/interoperability but it is not clear that every content item has associated business process attributes, especially so for eTMF solutions that do not incorporate workflow functionality.

The meaning of the term “Country Code” is not understood. Does this relate to the sponsor of the clinical trial or the original of the content? Typically, country is not associated with all trial master file documents/records, but only content that is site-specific or country-specific. For example, a clinical trial protocol or investigator brochure would not have a country code associated with it. Please clarify why Country Code is core.

Page 32- Business Process- Date of signing? Server date/time stamp or local? How is this handled?

The inclusion of a specific field ‘Digital Signature’ is not understood. If a document has been digitally signed, is the specification requiring that metadata about the digital certificate is manually entered into a digital signature field. The specification needs to provide extended text to explain how this term is to be used and what its purpose it.

Page 33- Core/Source Identifies fax as a source? How is the metadata handled in this instance?

Page 34 – Core Metadata – Content identifier – images How do you handle large volume image studies regarding numbering? (i.e. 2M images?). 20K subjects x 100 images get you there

In addition, the inclusion of ‘Person Name’ and ‘Person Role’ as mandatory items could be problematic. These are typically free text fields, resulting in the potential for errors, duplication etc.

Page 33 – Comment: Organization name should not be included. This will cause confusion unless it can be taken to a granular level. For example: a global organization such as Quintiles, how do I use or tie back this information with large global companies?

It is not understood why Subject Identifier is included as Core Metadata i.e. applicable to every content item. This term will only be applicable for subject-specific content e.g. case report forms, or AE reports.

Page 33- Question: Why does document not contain time? Documents must contain user/date/time. Time is important and must be included along with date.

Username is required as a term for Created By and Modified By; would this be a more acceptable term?

Domain based metadata highly incomplete and needs significant input from the industry

How would this work? It is TMF specific. [re: 'Note that the OASIS eTMF model can support other domains in life sciences or healthcare such as research and development, finance, administration, or others' highlighted]

The scope of the draft specification and scope of the OASIS TC is very specifically limited to the trial master file. It is therefore not understood why the first sentence in this section has been included as it has no relevance to the topic: “Note that the OASIS eTMF model can support other domains in life sciences or healthcare such as research and development, finance, administration, or others.” This statement adds no value and could result in confusion.

I have never seen this captured in any eTMF and don’t see the valueWhat I don’t see is the Investigator/Site Personnel ID

Page 35 – Comment: Credentials – Include everyone (all credentials) or include no one is the safe way to go. Needs to be dropped.

Page 35 – Comment: eCTD is insufficient. Needs to be addressed.

Should be a repeating group; same comment for Regulation

This is generally not a Yes or No answer. For example, a SAS transport file might not ever be included in a submission if a product is only registered in Europe. Is it meant to say that this type of document has the potential for eCTD submission? If so, I don’t see the value. Also keep in mind that EU Clinical Trial Authorisations don’t use the eCTD format.

Missing metadata: expiration date, unblinded content, vendor name, IRB/IEC Name, Agency Name, and much moreAnd what about DOCUMENT STATUS

These are too generic and would require further context (location of what? Sponsor? Trial execution? IRB?...

Need source term name, version, and term date; also consider the need to be able to keep terminology in sync with a changing external standard

Is this describing the TYPE or the SPECIFIC DOCUMENT? do not see any value for the specific document. This would be a nightmare to enter for hundreds of thousands of documents

What is the value of this when you already have country?

Isn’t this the same as Content Identifier?

How does this work with category/subcagtegory/etc.

Who defines those? Can they be used for trial posting or in an eCTD envelope?

The definition of ‘archive’ may be an accurate definition from a computer architecture perspective but it is not consistent with regulatory definitions, for example, the OECD definition of an archive (including the requirement for content to be under the control of a named archivist and suitable for long-term preservation of content). As this specification is to be used in a regulated domain, by professionals who understand the OECD, MHRA and EMA definition of an archive, the generic definition proposed should be avoided. The use of ‘archive’ elsewhere in this document must be avoided unless it corresponds with the regulatory meaning and definition of a GCP archive (e.g. see Repository definition).eCTD uses ISO3166-1 alpha 2; what 3 for TMF? Basic Audit Trail: type of change must be in the basic audit trail as well as what object was changed.

Opportunity to map to EDM Ref Model and eCTD by introducing other terms that captures the eCTD node and EDM reference ID respectively

Page 37 Question: Codes – Codes with Y reviewed by Carelex? Does this mean that Carelex will maintain ownership and oversight going forward?

Whether or not a code originated by CareLex or is pending review by CareLex is immaterial to this specification. Once agreed and published, all that matters is the code that needs to be used to uniquely identify the resource. There need only be two prefixes: codes that are included within the specification (e.g. commence with C) and codes which are not included in the specification (e.g. commence with Z). This specification is not a CareLex specification, NCI specification or TMF Reference Model specification; all codes and references to any such organizations within the coding system must be avoided.

This is missing two considerations: approval vs. drafts (lifecycle) and metadata only vs content change (which includes cases where metadata are exchangeed with the content which then constitutes a content change); first approved version is a 1.0 but first content version is a 0.0; metadata changes do not require versioning if the content was not changed.

Can you re-submit a previously submitted document with changes and expect it to be updated in the receiving system?

How do you relate multiple versions of documents received over time? Do they have the same ID and different versions, or different IDs? How do these map to commonly used terms such as Object ID (specific document ID) and Chronicle ID (version tree ID)

eCTC is based on the CTC which is an ICH not FDA standard; It was developed by the International Conference on Harmonization (ICH) Multidisiplinary Group 2 Expert Working Group

There are normally minor versions when draft content is updated [...There can be a new Minor version every time the metadata 'changes' highlighted]

relevance? Why is that needed in the TMF?

Please avoid using the word “archive” in this context for the reason provided above.

The definition provided will lead to confusion. GCP regulations also use the term “archive”, “archiving” and “archivist” to have a very different meaning. An archive is a repository that is designed specifically for the long term retention and preservation of records and is NOT a general digital file store.


C114463 Archive can be both electronic and physical.How to handle the TMF documentation in paper - here is only described for electronic archiving?

It is not understood why this term is included within the vocabulary. It adds nothing other than to provide an opportunity to promote CareLex.

It is not understood why this term is included within the vocabulary. It adds nothing other than to provide an opportunity to promote CareLex.

will CareLex act as a SDO and provide controlled vocabulary to the industry? If not, suggest to remove company references

if organizational role is used, sponsor attribute becomes redundant

C115462 – “Template” is not needed in the Preferred Term Template Advertisement for subject recruitment.

C115462 Column C (preferred term): The word ‘template’ has not been used for other content types that are templates. The definition makes is clear that this content type is the template or sample advertising material so ‘template’ can be removed from the referred term.

Remove "template" as it is irrelevant as all trial and country level documents are templates in this section.

Re: C115462 Why is this content type described as 'template'? This does not align with the TMF RM artifact 043

this is not a template but the acutal advertisement material approved by IRB/IEC; not aware that a template of the advertisement for subject recruitment is needed in the TMF

C115463; C115560; C115588; C115693; C115697; C115700; AND C115701 are all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts.

Regarding C115697, C115463, C115588, C115560, C115700, C115701, C115693. What is the rationale for having separate content types of all of these 'IRB-IEC Approved' items? This seems quite non-sensical as the 'approval' is really a processing result based on the same content that is not 'IRB-IEC Approved'

IRB-IEC Approved Advertisement for Subject Recruitment (043 / Advertisements for Subject Recruitment)C115462 / Template Advertisement for Subject Recruitment is also included in 043 – would be the version submitted to the IEC-IRB for review prior to approval.

C115468 OK, but not only for digitals…

Missing Risk Management and Vendor Management Plan

agree with artifact name change; artifact should not use abbreviations

those are sponsor owned documents already defined in the TMF RM; the fact that the IRB-IEC approved it is a process step and a lifecycle change, not a new object.

what about CRO, or other third parties? change to "third party…." (instead of "Vendor") or keep TMF RM name

C115466 Column F (definition): Consider clarifying “clinical supplies”, for example “….supplies, including but not limited to comparator drugs, diagnostic equipment, laboratory equipment, IT equipment”.

agree to replace "/" with "-" to reduce technical risk that special character can impose in system implementations (e.g. use of an artifact name in an auto-generated filename will cause issues on export to windows fileshare)


C115484 Very good to give interim its own section to distinguish from Final

C115485 Should also include Adjudication in synonym and definition

Remove "Investigator" since there are others at the sites that sign the CDA who are not investigator. Limiting. Change abbreviation. Add “CDA” to the synonyms.

although the classificaton implies an Investigator relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

C115476 – Preferred Term “Investigator Confidentiality Agreement” should be just Confidently Agreement since there are many people/entities at a site who must sign CDAs such as the investigator, sub-I, Institution legal representative, pharmacist. Add “CDA” to the synonyms.

Re: C115480 definition - Does this mean that this subcategory is for all 'non-local' IRB/EC communications? Where is 'local' defined, if anywhere, in this specification?

I do not think the including of "Sponsor" in the category name is 100%. I would remove as it only limits the content to be placed.Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description.Seems strange to break process to start the description with "Local IRB-IEC documents are filed under Site Management. "...Maybe move to end?

agree with artifact name change; artirfact should not contain explanation in "paranthesis"; this should be captured in the definition

Important to retain in the TMF. Could be applicable to an interim analysis as well as an IDMC analysis, etc.

no value in changing the definiton; please keep TMF RM definition

Re: C115488 - Is there no content type for CVs of other site personnel?

Remove "Lab" from preferred term. Use TMF RM term


Abbreviations should be avoided in an artifact name; please keep the TMF RM name

no value in renaming artifact; please keep TMF RM name







C115496 – Study Subjects Digital Photos -This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

synonym:Project Management; Trial Oversight

Should be Trial Oversight

Important to retain in the TMF.



C115497 Could the definition be emphasized to include all types/areas involved also outside Clinical Operation? Could be misinterpreted as only Clinical Operations leaving out i.e. Safety, Drug Supplies, Regulatory, suppliers and other areas

C115497 Column C (preferred term); Change 'Operations' to 'Oversight'. The term 'operations' is typically understood as 'trial conduct'. This subcategory of documents corresponds with oversight of the trial.

agree with the artifact name change

C115499; C115500; C115501; C115502; C115503; C115545, C115715; C115721; The following categories and sub categories are not needed since the purpose of these terms is to classify subject documents which are not part of the TMF.

although the classificaton implies Centralized Testing relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

although the classificaton implies Data Management relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok




although the classificaton implies IP and trial Supplies relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

although the classificaton implies Safety relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

although the classificaton implies Statistics relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok


C115510 – Study Subject CT report. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115511- Study Subject Medical Imaging Unspecified. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115512 – Study Subject MRI Report. This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115513 Study Subject Nuclear Medicine - This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115514 – Study Subject Radiology Report – This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115518 No comments

C115519 No comments

C115515 Study subject Ultrasound - This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115516 – Study Subjects Digital Photos Report – This is considered source documentation and is not included in the TMF. Individual subject data is not included in the sponsor TMF.

C115517 Column C (preferred term): Subject information sheets are not necessarily forms. I suggest removing the word ‘Form’. This content type is more commonly known by the term ‘Subject Information Sheet’. I suggest using this as the preferred term.

Term "Form" is not commonly use when referring to these preferred terms. Remove. Replace with "Sheet".

those are not always forms; please leave TMF RM artifact name

C115518 Column C (preferred term): Documents which fall into this category are not often forms. Please avoid using the word ‘form’ to avoid user confusion.

Use Term "Form" is not commonly use when referring to these preferred terms. Remove. TMF RM term is aligned with ICH and accepted industry term. Add additional description that TMF RM has "To be provided to the subject to further assist with understanding the trial requirements or concepts; may include memory aids."


C115518 – Consider expanding the term “other subject forms” to “other subject materials” to allow for other media than paper.

Why not abbreviate CRF here as was in C115750? Inconsistencies!

I prefer the TMF term as it is more general to the industry and from the ICH

C115519 Column C (preferred term): This content type is not usually a form. I suggest using ‘Subject Participation Card’ as the preferred term.

Term "Form" is not commonly use when referring to these preferred terms. Remove. Replace with "Card".


C115519 – The common term for this artifact is the Subject Participation Card not Form.


partly agree with artifact name change; artirfact should not contain explanation in "paranthesis"; this should be captured in the definition; but changing from "documentation" to "forms" has no added value and I like to keep TMF RM name

Site qualifications is a unique type of content collected that ensures the site has all of the requirements to conduct the study. Use the TMF RM artifact name/term and description as it is in the TMF RM "To document site / site staff qualifications not previously outlined on CVs. May include list of previous studies, publications, training certificates for specific examinations, ICH-GCP training, site GCP or trial licensure, medical licenses etc. Description needs to be broadened to qualification documentation for not only investigators.

this alters the meaning; this artifact is clearly intended to support the qualification of the participating site and staff; please leave TMF RM name

C115524 add “professional license” and “certification” to the synonyms

TMFRM 090 / Site and Staff Qualification Supporting Information

C115531 Column F (definition): change 'notes' to 'filenotes'.

C115526 Column F (definition): There has been some discussion within industry whether a Summary of Medicinal Product Characteristics (SMPC) document or equivalent (e.g. product leaflet) is equivalent to an Investigator Brochure for some studies / products under test. Consideration should therefore be given whether the definition needs modifying to accommodate such documents or whether additional content types need to be included within this subcategory.

Re: C115529 definition - If the definition is not limited to PIs, then why is this content type specifically named 'PI LIcense'?

Remove! This is not a required document in the TMF. Is a subtype of the Documentation of Staff and Site Qualifications, C11524, which would be applicable to SOME of the sub-investigators.

Should be generalized; attribute person name and role can provide specificity

C115529 & C115524 – are both preferred terms needed? Can Site Personnel Supporting information cover the PI license?


C115532 Column F (definition): The term "directory" is not clear and could be misinterpreted. The word ‘list’ is more usually used.


TMFRM 105 / Subject Log

agree with modified term; it provides better clarity

Re: C115537/C1155378 - This is represented by a TMF RM v2.0 artifact, 'Subject Identification Log', unique id 105. What is the rationale for breaking this TMF artifact into two content types?

Preferred term is currently Subject Screen Log. Consider changing to Subject Screening log per ICH.Subject Identification Log is NOT a synonym for this term. It is a unique artifact that is site specific and not part of the sponsor TMF but part of the investigator site file yet still part of the overall TMF . Remove and make a unique preferred term unto itself like within the TMF RM. Source Data Verification is valuable TMF artifact as it is used and sometimes retained when remote monitoring is conducted. Applicable at all 3 levels.

C115538 Preferred term is currently Subject Screen Log. Consider changing to Subject Screening log per ICH

agree with artifact name change

Remove "Lab" from preferred term

Do not agree with addition of Bioanalytical

C115546 No comments

C115547 Column E (abbreviation): Include ‘Mngt’ for consistency.

Rename to 'Trial Management Filenote"

alters the meaning and limits artifact; please keep TMF RM name

C115546 Agree with proposals.

There are filenotes associated with the creation and distribution of central trial documents

although the classificaton implies a central trial relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

C115547 Column C (preferred term): I recommend including the term “Trial Management” for consistency with filenotes in other categories i.e. ‘ Trial Management Filenote’.

C115548 No issues

Important to remain in the TMF

C115547 Column D (synonym): The term ‘Note to file’ is a commonly used synonym. I would recommend inclusion.

insignificant change; please leave TMF RM artifact name

although the classificaton implies a regulatory relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

although the classificaton implies site management relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

although the classificaton implies an IRB-IEC relationship, I agree adding it in the artfact name gives the artifact itself meaning outside of the classification context. In a distributed content model where artifacts are viewed outside a source categorization this becomes very important; adapted definition is ok

C115551 Column C (preferred term): Please note that this documentation is not necessarily related specifically to “safety information”. The preferred term is therefore not accurate. Documentation included within this definition could include, for example, serious breaches of GCP (not safety related) or any other regulatory reporting obligation.


TMF RM artifact name was more specific; please keep the TMF RM artifact name



C115556 I agree with the proposed subcategory name “Clinical Trial Oversight Committees” and definition.

I think the term "Oversight" is not always correct and needs to be removed since there included in this section are Steering committees, adjudication committees, approval committees, etc.

C115556 Suggest to include Adjudication in Synonym and in Definition to reflect input in C115644

Remove "s" from "Pubs" in the abbreviation. Use TMF RM description as it is more accurate "To describe the policy for publishing the trial results if publication policy is not captured within the protocol or Clinical Trial Agreement."

IRB-IEC Approved Subject Questionnaire (039 / Subject Questionnaire)

Prefer TMF RM term "IP Documentation of Return"


C115557 Column F (definition): the wording proposed is not easily understood. Use of the word 'approved' is unnecessary, unless it is going to be used consistently across all content types. Propose: Documentation describing the policy for publishing the trial results.

Term "Form" is not commonly use when referring to this preferred term. Remove.








I would suggest that this term be broadened to all the documentation associated with relabeling…and applicable at trial, country, and site level. Call it IP Transfer Documentation.

agree with artifact name change; better context


Gerneralize in one artifact: Study Subject Result Data in section 'trial documents' and specify type of result data in an attribute

Preferred term is not one that the industry will identify with. Prefer the TMF RM term


Do not agree with addition of Bioanalytical to the term. Prefer the TMF RM term. This is NOT only bioanalytical related. Since centralized testing could be done at a non-laboratory. Important to hold all other subject data that does not have a place specifically identified. However, one does not have to specific unique preferred terms and instead retain this preferred term as the general one and let metadata distinguish the different types. This is a preferred method since a subject could have multiple types of source data and it would be all together organized and listed with the same preferred term - and metadata should uniqueness of the multiple entries.

alters the meaning and limits artifact; please keep TMF RM name

Is the Abbreviation correct "Stas"? I would suggest 'Stat"


C115575 Column C (preferred term): Inclusion of the word ‘Final’ gives the impression that interim reports are not required. In addition, there an eTMF has document authoring and lifecycle management functionality, draft documents will be classified against this content type. The word ‘final’ is not necessary.

Remove "Final" as not all time are the reports captured in this section would be final.

synonym: Site Initiation Report

C115576 – Trial Initiation Monitoring Report – add Trial Initiation Monitoring Report waiver to the synonyms

add Routine Monitoring Visit Report and Interim Monitoring Visit Report to the synonyms

C115577 Monitoring Visit Report, add Routine Monitoring Visit Report and Interim Monitoring Visit Report to the synonyms

Remove "Trial" from the preferred term name as this could be added to most term names. Doesn't add anything here.

C115580 Column F (definition): consideration should be given to expanding the definition to avoid ambiguity with formal status reports required by regulatory agencies, IRB-IECs and other official bodies.

Re: C115581 - What is the rationale for a close out visit report, and other monitoring content types, to be included under the subcategory 'Investigator Documents'?

Important to retain in the TMF. Although could be moved to Central Trial Documents

TMF RM name more refined; please keep it

Important to retain in the TMF. Although could be moved to Central Trial Documents

IRB-IEC Approved Subject Diary (038 / Subject Diary)

synonym: Pre Trial Assessment Visit Report

C115586 –Pre Trail Monitoring Report – Add Pre Trail Monitoring Report Waiver to the synonyms


C115589 Column C (preferred term): Subject diaries are not necessarily forms. I suggest removing the word ‘Form’.

Term "Form" is not commonly use when referring to this preferred term. Remove. Also diaries are not forms anymore…they are electronic




C115593 Column F (definition): the wording proposed is taken from a specific US regulation and therefore may not be aligned with equivalent regulations globally. Propose making the definition more generic and simple e.g. a declaration that certifies whether trial personnel are or have been barred, suspended, proposed for debarment or in some other way declared ineligible to fully participate in trial activities.

C115597 No comments


not the same; keep TMF RM which is broader in definition

There are communications associated with the creation and distribution of central trial documents



C115596 Definition should be changed to: Types of correspondence may include, but are not limited to: Letters, Memos electronic communication and faxes (Text from TMF-RM)


There are trackers associated with the creation and distribution of central trial documents



agree with new name; provides better context and specificity

synonym: Monitor Meeting



C115605 Column F (definition): The content of this subcategory is not exclusively for trial start up e.g. training materials, trial management communications.

C115605 Column C (preferred term): The content of this subcategory is not exclusively for trial start up e.g. training materials, trial management communications. Do not agree with this sub category name since any of the preferred terms could happen at any point during the trial. Use the TMF RM term "Meetings"

C115606 Trail Team Training Material – the definition includes both the training materials and the documentation that the training was completed. However, at the site level, there are 2 categories, 1 for the materials C115604 and 1 for the documentation that the training was completed C115674. For consistency, should there be 2 terms at the trail level as done at the site level. Or at a minimum add “training completion document” as a synonym.


C115611 No issues






C115612 No issues






all IRB-IEC approved artifacts. These artifacts are already accounted for with a Trial classification in Subject Forms. By classifying these artifacts with the Category Code of Trial they will be the template for the Trial. Adding the Category Code of country will account for the country specific template version or country central IRB approved version. Add the Category Code of Site will account for the final IRB approved version. There is not a need to additional preferred terms for these artifacts.

C115617 Could definition of Clinical Trial Team be more specific, i.e.: Include Sponsor and Third Party but not Site Staff

C115617- Trial Team Definition is not clear. What is the difference between this and C115659?

are those the same? If yes, new name is more 'professional'

agree with the artifact name change

Preferred term is incorrect. Randomization is not validated in all cases. Use the TMF RM term.

C115627 Column E (abbreviation): As explained, avoid use of the term ‘Amendment’ or ‘Amend’.

Do not use "Documents" in the preferred term…Use TMF RM term.

C115627 Column C (preferred term): Protocol amendments are already included in content type C25320 (including ‘Protocol amendment’ as a synonym). To remove the confusion that already exists with the terms used in the TMF RM, I propose removal of the term ‘Protocol amendment’ in any column for this content type. The preferred term should be ‘Protocol changes’ or ‘Summary of changes’. It is a document that highlights or lists the changes in one version of the protocol (a protocol amendment) compared to the previous version (the original protocol or a prior protocol amendment).


C115636 Column C (preferred term): Whilst I understand the desire to maintain some alignment with the TMF RM, the term used is inconsistent with other category terms. The remaining categories have name reflecting a trial activity, function or process; “Central Trial Documents” is inconsistent in this respect. Although I am not able to propose an alternative, I recommend that thought is given to proposing a term that reflects a trial activity, function or process that is covered by these documents.

C115637 Column C (preferred term): The inclusion of the word ‘documents’ in unnecessary and not included elsewhere for category and subcategory terms. Propose changing to ‘Central Trial Communications and Tracking’.

Name of sub category is not reflective of the content within as it is missing the meeting documentation and file notes. Add "meeting documentation and file notes" into the description.




insignificant change; please leave TMF RM artifact name

C115638 What is the difference between this and and C115658?Definition should be clearer, what documents are included here?One could be confused where to file documentation; here or in C115658, should be clearer


Name of sub category is not reflective of the content within as it is missing the meeting documentation and filenotes. Add "meeting documentation and file notes" into the description.


Not all preferred terms will be relevant to all types of centralized testing facilities. Just and FYI when you consider names of the preferred terms. Not all centralized testing will be "Labs". Need this to be more general.

"Core" doesn't mean much here and can be very confusing to the TMF RM community since we use the term "Core" for another purpose. Recommend removing term

C115647 Column F (definition): The definition appears to be adapted from the TMF RM. Please state [Adapted from TMF-RM].

Remove "s" from Document in the preferred term name to stay consistent with other terms


Description should be clarified to say " investigators and investigative site".



C115658 I agree with the content proposed.



C115651 Column F (definition): The definition appears to be adapted from the TMF RM. Please state [Adapted from TMF-RM].


C115656 Column C (preferred term): The inclusion of the word ‘documents’ in unnecessary and not included elsewhere for category and subcategory terms. Propose changing to ‘Trial Management Communications and Tracking’.


C115658 – Internal process tracking is not required to be contained in the TMF. Consider deleting.

C115658 Trial Management Tracking Documents – these are not required documents and are not necessary to include in the TMF

C115658 – Items in this definition are too broad. Suggest trip reports and investigator initiation move to a site management section rather than the trial tracking area

synonym:Trial Contact List

Abbreviation sounds weird. Maybe "Prot Deviatn"

Update description to include "regulatory submissions and approvals."


C115666, Regulatory Tracking Document No comments

C115658 The definition raises a concern to what should be included in the TMF. Tracking can be done in all sorts of systems… Could the authorities from this expect tracking of all activities in a trial? If tracking is present, should actions also be included? Is it the tracking or the outcome (actions) that should be filed here?


C115666 No issues


C115666 – Regulatory Tracking document is an internal process document and not required to be maintained in the TMF



Add synonym "Investigator Site List"

Consider revised name of preferred term "Site Signature and Delegation Log"

C115675 No comments

Do not use "Documents" in the preferred term…Use TMF RM term.Important to retain in the TMF.

no value in artifact name change; please keep TMF RM name

C115675 Column C (preferred term): The content types included within this subcategory are not necessarily forms, particularly for EDC studies and for advertising materials. I suggest removing the word ‘Forms’.

Term "Form" is not commonly use when referring to these preferred terms. Remove.

Remove "Trial Supply" and Shouldn't this have "documentation" or record after it….like was done for other preferred terms. Prefer TMF RM term


Remove "Trial Supply" and This subcategory name is not correct…it should be IP Storage]

Remove "Trial Supply" and Shouldn't this have "documentation" or record after it….like was done for other preferred terms. Prefer TMF RM term





Category 109 It is not clear how documents related to the definition, development, testing and procedures for a trial-specific EDC system are differentiated from those for a separate clinical database. It is often the case that one system is used for implementation at investigator sites for electronic data capture but for the data received to be imported into an enterprise clinical database (e.g. Oracle Clinical). Subcategory 109.12 appears to deal with documents related to the EDC but I’m not seeing equivalent documents for subject database (which would exist for paper CRF studies as well as for EDC studies).



To me, the preferred term and the TMF RM term are 2 different things. This preferred term should be more than just a certificate.

Prefer TMFRM 246 Validation Documents Note: "244 / Database Change Control (Paper and EDC)" is not applicable here, refers to documents for CRF changes requested during a study (application modification requests, etc.)

are those the same? If yes, new name is more 'professional'


Preferred term is incorrect. The system access is managed, not the database. Use the TMF RM term.


A better name for this would be "Evidence of Vendor Oversight" since the section is not specific to contractors but all vendors.

108.10.10 This content type includes a wide range of documents. Consideration should be given to providing greater granularity to better reflect best practice in industry. For example, initial evidence of vendor qualification could be differentiated from ongoing activities to confirm oversight of the services provided by the third party 9e.g. visit reports, quality questionnaires).

A better name for this would be "Evidence of Oversight" since the section is not specific to contractors but all vendors. Also, yes, this would include evidence, but it also includes the plan for oversight. Prefer the TMF RM term.


Re: C115691 This category appears to be specifically for any communication between a sponsor and a certain type of IRB/EC? Not sure the value of breaking this out from other IRB/EC communications is clear and/or useful.

Re: C115691 definition - "General IRB documents are trial level documents" - what does term 'General IRB' mean? What about country-specific ECs, are those also considered 'trial level' documents?


C115691 Column C (preferred term): Inclusion of the word “Sponsor” is not understood. How would this category be used within an Investigator Site File, for example (an ISF ide defined as part of the TMF)? This category is not restricted just to Sponsor documents. Furthermore, it is not understood why site-level documents are excluded from this category. Common industry practice is to classify all IEC/IRB documentation in a single category and to use metadata to define trial-level, country-level or site-level documents. The inclusion of sub-category 104.13 provides for site-level IRB/IEC documents but does not provide for country-level IRB/IEC documents.The rationale for departing so widely from the commonly adopted TMF Reference Model classification is not understood and is likely to cause issues for implementation. It is assumed that any IRB/IEC document other than file notes, meeting materials and tracking documents will be classified as 103.10.10. At the trial level (excluding site-specific IRB/IECs) this includes: IRB/IEC submissions, IRB/IEC approvals, IRB/IEC decisions, routine updates to IRB/IECs, composition lists for IRB/IECs, IRB/IEC GCP compliance statements, notification of safety events to IRB/IECs, notification of trial termination to IRB/IECs. Classifying all such documents as T103.10.10 will not assist interoperability as users of the standard will want greater granularity for this content type.

I do not think the including of "Sponsor" in the category name is 100%. I would remove as it only limits the content to be placed.Honestly I am confused with this category which is a 4 term category with no other TMF content associated with it. There exists many different types of IRB-IEC content that is managed at the country level, not just at the site level. In this structure I cannot understand where that content now exists

I have reviewed the rows 82 [C115691] to 152 [C115549] of the OASIS vocabulary and have no further comments. Seems completely logical to me.


C115692 IRB-IEC Tracking document. Process tracking is not a required TMF document. Consider removing

IRB-IEC Approved Other Subject Information (044 / Other written information given to subjects)



Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents.


I feel very strongly that IEC / IRBs should have their own category, not be a subcategory of Category 104, for the sake of flexibility. Many countries do still have local site-specific IEC/IRBs, but there are also many have only a national IRB/IEC which is not site-associated, or a leading IEC/IRB which provides the approval for all sites in the country. Many of the submitted and "IRB-IEC Approved" documents are only applicable at study or country level – not separately for each site. Many IECs/IRBs can be responsible for more than one site within a country without being responsible for all. I know of at least 2 countries where the submission documents for IEC/IRB review are required to be submitted to the national health authority which reviews and routes these to the national or local IEC/IRBs as required. EMA has also thought about forming an EU-Regional IRB – one more reason not to classify IEC/IRB documents as site-specific.

IRB-IEC Approved Informed Consent (= TMFRM 040 / Informed Consent Form)

In the TMFRM Model, all versions (draft + approved, translated, Study/ Country/ Site levels) are included in the designated artifact ("IRB IEC Approved" is considered to be metadata):C115697 IRB-IEC Approved Informed Consent (= TMFRM 040 / Informed Consent Form); C115463 IRB-IEC Approved Advertisement for Subject Recruitment (043 / Advertisements for Subject Recruitment)C115462 / Template Advertisement for Subject Recruitment is also included in 043 – would be the version submitted to the IEC-IRB for review prior to approval.C115588 IRB-IEC Approved Subject Diary (038 / Subject Diary)C115560 IRB-IEC Approved Subject Questionnaire (039 / Subject Questionnaire)C115700 IRB-IEC Approved Subject Information (041 / Subject Information Sheet)C115701 IRB-IEC Approved Subject Participation (042 / Subject Participation Card)C115693 IRB-IEC Approved Other Subject Information (044 / Other written information given to subjects)

The principal of having IRB / IEC approved documents as well as the documents themselves is unmanageable as a concept – version 1 will be finalised at a trial level, then maybe at a country level, then maybe at a site level. They will all be masters, they could all need EC approval. Approval would be an ongoing process, so documents would have to be copied from the master location to the approved location as they are approved. What happens if a trial master is approved at half the sites but not all sites? Does it go in the approved artifact? If it is stored at site level, you could have multiple copies of a single document being stored.

Do not agree with IRB documentation being captured separately apart from country level IRB-IRC documents.



IRB-IEC Approved Subject Information (041 / Subject Information Sheet)

IRB-IEC Approved Subject Participation (042 / Subject Participation Card)



C115702 Whilst understanding the rationale for maintaining alignment with the TMF Reference Model as much as possible, consideration should be given to removal of this subcategory, which only contains 2 content types. The 2 content types (export/import license and applications) could be considered documents necessary for trial approval and therefore be classified in subcategory 102.10 (Trial Approval).

This is a very confusing sub category name. I had to reread it to make sure I was in the correct section "regulatory". Suggest to change to "Licenses"

C115702 Column C (preferred term): If this sub-category is to remain, the term “Investigational MEDICINAL Product” appears to exclude devices and other investigational products that are not medicines e.g. contrast media. I suggest using the term “Investigational Product”.


Do not use "Documents" in the preferred term…Use TMF RM term.Important to retain in the TMF.

105.10 The subcategory name and definition is not clear enough; the definition duplicates that for the whole category.


C115711 No comments

Most common term I see is "IB Receipt"



synonym: IP Site Approval

definition change is not adding value; keep TMF RM definition; this can also be a workflow event or simple system access configuration, where investigators have access to the TMFdirectly and there is no send-receive transaction

no value in renaming artifact; "Certification or Accreditation" is a well establisthed industry term; please keep TMF RM name


What is the rationale for these subcategories and content types not being organized under 'Data Management' category?

I do not understand why this set of documents is classified as a separate category. These are documents that are specific to individual trial subjects. Completed case report forms are integrated into the Data Management category so I would expect this set of documents to also be integrated into the most appropriate of the existing categories e.g. data management or Site Management. In addition, medical imaging documents is just one example of source documents that ICH GCP requires the investigator to maintain within a trial master file. It is not understood therefore why medical imaging documents have been included but not for other source documents. The definition should also make it clear that source documents such as these are the responsibility of the investigator and NOT the sponsor. Finally, it is not understood why there is this level of granularity provided. I would expect a smaller number of content types to be list, requiring the system to apply metadata to differentiate between different imaging types if this was important/necessary for filing purposes. Providing this level of granularity runs the risk of the vocabulary needing to be revised as new imaging technology and techniques are used. Generic terms should be used.

All of the below = TMFRM 162 /Laboratory Results Documentation (see definition – includes "or other testing facility"):C115496 Study Subject Digital PhotosC115516 Study Subject Digital Photos ReportC115561 Study Subject Radiography ImageC115514 Study Subject Radiography Report( findings associated with an X-ray image)C115539 Study Subject MRI ImageC115512 Study Subject MRI ReportC115481 Study Subject CT ImageC115510 Study Subject CT ReportC115553 Study Subject Nuclear Medicine ImageC115513 Study Subject Nuclear Medicine ReportC115619 Study Subject Ultrasound ImageC115515 Study Subject Ultrasound ReportC115523 Study Subject Medical Imaging UnspecifiedC115511 Study Subject Medical Imaging Report Unspecified

Cannot understand why these specific types of source data are separated out. Identifying some but not all will be confusing to the general TMF owner and will create a lot of extraneous content types to sift through to manage e content. Why could these not be a single type with metadata to distinguish. This is a really big change to the TMF structure list that was kept broad for a reason...to allow wide spread use and acceptance across the world's bio pharma and device companies. Not aligned with the TMF RM.

There are 22 subject data preferred terms around imaging – this is completely unaligned with the rest of the TMF Reference Model. Lab data in not included, and therefore other subject data has not been included. The level of detail in these preferred terms is again unaligned.

I do not understand why this set of documents is classified as a separate category. These are documents that are specific to individual trial subjects. Completed case report forms are integrated into the Data Management category so I would expect this set of documents to also be integrated into the most appropriate of the existing categories e.g. data management or Site Management.In addition, medical imaging documents is just one example of source documents that ICH GCP requires the investigator to maintain within a trial master file. It is not understood therefore why medical imaging documents have been included but not for other source documents. The definition should also make it clear that source documents such as these are the responsibility of the investigator and NOT the sponsor.Finally, it is not understood why there is this level of granularity provided. I would expect a smaller number of content types to be list, requiring the system to apply metadata to differentiate between different imaging types if this was important/necessary for filing purposes. Providing this level of granularity runs the risk of the vocabulary needing to be revised as new imaging technology and techniques are used. Generic terms should be used.C115715 Medical Imagining – documents regarding standardized processes and procedures could be captured in Centralized Testing or Vendors.

C115716 No comments

All of the below = TMFRM 162 / Laboratory Results Documentation (see definition – includes "or other testing facility"): C115496 Study Subject Digital PhotosC115516 Study Subject Digital Photos ReportC115561 Study Subject Radiography ImageC115514 Study Subject Radiography Report( findings associated with an X-ray image)C115539 Study Subject MRI ImageC115512 Study Subject MRI ReportC115481 Study Subject CT ImageC115510 Study Subject CT ReportC115553 Study Subject Nuclear Medicine ImageC115513 Study Subject Nuclear Medicine ReportC115619 Study Subject Ultrasound ImageC115515 Study Subject Ultrasound ReportC115523 Study Subject Medical Imaging UnspecifiedC115511 Study Subject Medical Imaging Report Unspecified

Submissions non-IRB-IEC Committees. Synonyms: Add Radiology Board Submission, Research Review Committee Submission, Budget Committee Submission. Category code should be at the Trial, Country and site.

changed meaning; the new name explicitely excludes IRB-IEC submissins whereas the placement in the zone: ' IRB/IEC and other Approvals' suggests both.; I prefer the TMF RM name for more flexibility, however, the defintion needs to be adjusted to match the zone

C115716 Submissions non-IRB-IEC Committees. Synonyms: Add Radiology Board Submission, Research Review Committee Submission, Budget Committee Submission. Category code should be at the Trial, Country and site.

C115716 and C115736 (Other submissions and approvals / under review) – yes, these are needed according to local laws, as stand-alone documents and sometimes for submission to IEC/IRBs.


synonym: Local Health Authority documentation (assuming country and/or HA attribute is provided to distinguish

Why not abbreviate SAE here as was in 115587? Inconsistencies!


C115723 Column F (definition): The definition “recording compliance with government regulations and laws.” is not specific enough.

Is this content organized in a country level process. I do not see a country level file in this model. All of this content is unique per country. Sites within the country supported but the country TMF content.


agree with artifact name change; artirfact should not contain explanation in "paranthesis"; this should be captured in the definition; abbreviaitons should also be avoided






C115734 Consider to mention Eudract and UTN in defition as well

no value in artifact name change; please keep TMF RM name

C115736 No comments



TMF RM name is more accurate since the registrations are public. The content in this section contains internal processes for the collection and approval of the content to be placed on a public registry as well as the documentation that it was placed.

agree with the artifact name change (avoid "&" in the artifact name)

Consider changing the metadata term to Approvals no-IRB-IEC Committees. Synonyms: Radiology Board Approval, Research Review Committee Approval; Budget Committee Approval.

C115736 Other Approvals. Consider changing the metadata term to Approvals no-IRB-IEC Committees. Synonyms: Radiology Board Approval, Research Review Committee Approval; Budget Committee Approval.

this is confusing; does that include IRB-IEC approvals? The artifact name should reflect that; if it is non HA approvals I suggest to rename the artifact accordingly to distinguish from the "approval" artifact in the regulatory zone (053) which should probably be named: Health Authority Approval


Should be titled Other Tiral Committee Documents

artifact name change has no additional benefit; please keep original TMF RM name


Abbreviation makes no sense since this level of abbreviation was not used previously. Maybe "Sites Eval N Sel"C115740 What is difference between dependent and non-independent committee - and is this only related Data Monitoring or could monitoring be included (i.e. calcitonin)

C115740 Column C (preferred term): Omit word "Non-IDMC" as this is implied in inclusion of the word "Unspecified". Change definition to "Any document related to committees not specified elsewhere". This artifact is not restricted to just non-IDMC.

Synonym is not necessary in this line, right? There could be so many more examples of these committee added if you will keep this header synonym. Too long a term and could be confusing, please use TMF RM term "Other Trial Committee" inducing description and change Abbreviation to "Oth Trial Cmte Doc"

this is not a name change; this document has an altered meaning; TMF RM was less restrictive; please leave TMF RM artifact name



Add synonym "Vendor Oversight Plan" which was removed from C115777


Why not abbreviate CRF here as was in C115750? Inconsistencies!

108 The term “third parties” is more usually used. The term “vendor” implies provision of a product or service in exchange for financial reward. Whilst this is often the case, it need not necessarily be the case for the provision of trial-related services. Third parties is a more neutral term, implying any party other than the sponsor and investigator. It is the term adopted by the TMF Reference Model.

I prefer "Third Parties". So many sponsors do not see CROs as Vendors. Remove "Vendor" from all preferred terms

108.11 The subcategory name is too ambiguous. In addition, the definition is not clear viz. agreement between vendor and CRO or between vendor and sponsor.

This category name means nothing to me. Too general. Use TMF RM Section name.






Missing Training Plan and a section for any other non-standard plans created for a specific study.

C115753 Column D (synonym): Remove synonym 'Monitoring Data Plan'. This could be confused with 'Data Monitoring Plan' a distinct document produced by Data Management.

synonym: Filing and Archiving Plan

synonym:Trial Management; Project Management

Synonym "Monitoring Data Plan" is not a common synonym used by the industry. I would suggest to remove.



This will include more than the plan; it will include results as well. Use the TMF RM term

I would suggest that this term be broadened to all the documentation associated with recall…and applicable at trial, country, and site level. Call it IP Recall Documentation.

this is more than a "plan"; please keep TMF RM name

I would suggest that this term be broadened to all the documentation associated with relabeling…and applicable at trial, country, and site level. Call it IP Relabeling Documentation.


C115764 Column F (definition): Definition could be confused with SOPs. Propose adding 'not covered by SOPs'.

C115764 Work instructions are often controlled documents which live under SOPs and should not be syonym for Operational Study Manual

C115766 Column F (definition): Change 'operations' to 'oversight'. The term 'operations' is too broad and could equate to the conduct of the trial (ie everything!).

C115766, Definition Could the definition be emphasized to include that this section also comprises documentation from other areas than Trial Management/Clinical Operations, i.e. Safety, Drug Supplies, Regulatory, suppliers and other areas?


C115777 Column D (synonym): Omit 'Vendor Oversight Plan'. This is more typically a separate, distinct content type, meeting different regulatory requirements than the Quality Plan. It is covered by TMF RM artifact 237 which has not yet been included in this vocabulary.

C115777 Vendor Oversight Plan is listed as a synonym. This is different from a Quality Plan. Quality Plan should be added as its own term.

Vendor Oversight Plan is not the same as the Quality Plan and Is there a typo in the Synonym "Join"? Though honestly, I think the name "Join Vendor Oversight Plan" needs to remove the "Join" and it be placed as a synonym of C115744.Remove "Quality plan" as a synonym since it is the same term as the preferred term. I would suggest that the abbreviation be "Qual Plan" not "QA Plan" since this implies that QA creates the plan and places in the TMF. Not the case for most companies. QA does create a plan that is often not kept in the TMF. This will cause confusion.

C115779 Column E (abbreviation): The proposed abbreviation (SOPs) may imply that the actual SOPs are required in the TMF. This implication should be avoided - change to ‘SOP List’

C115779 Column F (definition): The definition may imply that only SOPs that were current for the whole duration of the trial should be itemized (ie omit ones that were superseded or became effective part through the trial). ANY SOP that was current for any length of time during trial conduct must be .listed.

C115779 Work Instructions are often controlled documents which live under SOPs and should be listed as a synonym for SOPs

C115779 Column D (synonym): The proposed synonyms may imply that the actual SOPs are required in the TMF. This implication should be avoided - remove synonyms.

Term "SOP List" is not descriptive of that needs to be captured. Use TMF RM term which comes directly from ICH

Add Project Plan as a synonym

Remove "s" from "Comms" in the abbreviation

Please use ICH definition of the TMF, not Carelex's interpretation.

Please use ICH definition of a trial master file.

C20108 No comments

synonym [Preferred Term is being referenced]: New name is not as specific; please keep TMF RM name; List of applicable SOPs

C115780 Add 'Project Plan' as synonym

The suggestion of more than 1 abbreviation for content types (column E) is inconsistent with the objective of harmonization and is also considered unnecessary. I propose that only 1 abbreviation is included in the vocabulary.

C115780 Column E (abbreviation); Use abbreviation Trial Mgmt Plan; TM Plan is very ambiguous.


Please use derivative of the MHRA's definition of a eTMF per the MHRA GCP Guide.

Replace patient with subject in description. Not all participants in a clinical trial or study is a patient.

C16735 Column D (synonym): ICF is a commonly used synonym for Informed Consent Forms.

Absolutely critical to the organization of the TMF

"eCTD ICH guideline uses ISO 3166-1-alpha-2; why alpha 3?Also, context needed; country of what? Trial execution, Sponsor?..this is even more important as TMF does not exist in a vaccuum and has to integrate with systems designed for other content/process domains"

To facilitate interoperability, the date format should be mandated and not be a recommendation only.

need context; date of what? In real implementation there would be several dates, e.g. HA approval date, trial start date….etc…

person name format should be recommended as: Lastname FirstName MiddleInitial

This definition is unclear; please describe further; examples would help too

C25320 Column F (definition): The inclusion of the word “formal” is not understood and is inconsistent with other definitions included within this vocabulary.

C25320 Column F (definition): The definition should state that protocol amendments are also considered to be content type C25320; these are sometime (incorrectly) considered to be a separate content type.

C25320 Column D (synonym): Please also include ‘Clinical Investigation Plan’. This term is commonly used for the protocol in device clinical trials and is the term used within the devices ISO standard.

The need for this attribute for interoperability is not understood or explained within the specification.

location of what? Sponsor? Trial execution? In practical use the attribute has to be more specific to give it the right context

purpose? How will that free text field be utilized?

relevance; why is it important? May not be traceable for information coming to the TMF after several hand-offs

Requires standards to be defined to facilitate interoperability. The status of an object in the destination system must be identical to the status of the object in the source system.

what is the relevance of this attribute given that the document types (artifacts) are grouped in zonces?

this alters the meaning; the document in question is the blank CRF; leaving out "sample" could mean the completed CRF; please leave TMF RM artifact name

C40988 Column G (category code): The sample CRF should be classified with other Subject Document Forms i.e. subcategory 101.11

C40988 Column F (definition): The term ‘optical’ is not understood. The medium upon which the CRF is recorded is irrelevant with respect to classification. It is helpful to include printed and digital in the definition but inclusion of ‘optical’ does not seem to serve any purpose.

user name format should be recommended as: Lastname FirstName MiddleInitial

vague; 'preset' to what by whom?

traditionally we disctinguish title and object name; Title: The title and subtitle (where applicable) of an object as it appears in the document or the title page component of a composit document; what you are describing is often referred to as: object name (Short name for the document to help identify the document when looking at document listings in the system.)

Note that the FDA M1 ectd guidance was changed and refers to it as Form with subtype: 1572


Note – In the TMFRM Model, all versions (draft + approved, translated, Study/ Country/ Site levels) are included in the designated artifact ("IRB IEC Approved" is considered to be metadata):

This term should be Approval to stay consistent with C79189

This term should be Regulatory Approval to stay consistent with C70885

please keep TMF RM definition which is more specifc: A set of documents, along with required regulatory forms, submitted to one or more regulatory agencies requesting approval to conduct the trial or for the purpose of notification, or requesting approval of changes to the trial documents or of any trial events that could adversely affect the safety of subjects, impact the conduct of the trial or alter the regulatory authority's approval/favorable opinion to continue the trial. Example Investigational New Drug Application (IND), Clinical Trial Application (CTA), Investigational Medicinal Product Dossier (IMPD), Investigational Device Exemption (IDE)

that is not a property that is a content type

Use the more comprehensive description from the TMF RM "To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report; contains data listings and summaries."

C79189 Column C (preferred term): The process for seeking and receiving approval to conduct clinical trials varies significantly globally. In many cases, there is no longer an explicit letter of approval. It would therefore be preferable to use a more generic term for this artifact, such as “Regulatory Notification”. This notification could consist of an approval letter – where those agencies provide it – but more commonly would consist of acknowledgement that a submission package had been received and the required number of days had elapsed to allow the trial to go ahead.

C79189 – The Preferred Term should be “Regulatory Approval” or C70885 should be “Submission”. These two should be consistent.

C80447 – include electronic signature as well

C83082 No comments

Absolutely critical to the organization of the TMF

C79189 Column F (definition): As described above, this document often does not include explicit approval/authorization. I suggest changing to “A notification received from a regulatory authority stating that the Regulatory Submission has been received and there are no objections to the trial progressing.”

C79189 Column D (synonym): As described above, I suggest using “Approval” and “Authorization” as synonyms for “Regulatory Notification”.

C79189 Include in Synonym: NotificationOften approvals are also notification. Include notification in synonym to avoid confusion/misunderstanding

Change preferred term to 'Bioanalytical' Report as this is more broad and can then include multiple types of reports not just PK. Update description to be "Documentation that presents and summarizes the findings of the bioanalytical analyses from a trial."

C79278 Other types of reports are not mentioned here. Type could be i.e. Metabolism, Biomarker, etc. - are these included elsewhere, if not, these should be added

No detailed specification provided for digital signature? No detailed specification provided for electronic signature?

"specifiy data, e.g. FDA:the printed name of the signerthe date and time when the signature was executedthe reason for signature"

Prefer TMF RM term as the Unblinding plan is not only at the subject level, it can be at the trial level


Add synonyms "Periodic report, Interim Report, Annual Report"

C97107 - Synonyms: add Periodic report, Interim Report, Annual Report

"Protocol ID definition: Unique identification assigned to the protocol by the sponsoring organization, usually an accession number or a variation of a grant number. Multiple studies conducted under the same grant must each have a unique number Source: http://prsinfo.clinicaltrials.gov/definitions.htmlsynonym: Protocol number

should define standard Org IDs to be used. E.g. DUNS Number (Dun and Breadstreet) which is widly used including by the FDA as unique facility identifier.


Suggestion: I definitely agree with all comments made that it is imperative to harmonize the OASIS classification numbering system with that of the TMF Reference Model. In such cases as listed above [821.CSD1 & 822.CSD1], the different documents would be identified in metadata for that Content Type. Please consider whether it might be useful and practical for harmonization to add a classification "Content Sub-Type" for such cases as above, e.g. For C115697:C115636 Category "Clinical Trial Documents" / C115675 Subcategory "Subject Document Forms" / C16735 Content Type "Informed Consent Form" / New: Content Sub-Type: "IRB-IEC Approved" (as opposed to "Final Submitted")

For all 'document types' whose names deviate from the TMF RM v2.0 artifact names - what is the rationale for the deviation? Doing so will only make it more difficult for industry & vendors to understand this model (and therefore less likely to use it)

Seems unnecessary to use the term 'documented' in these definitions. Content that meets the definitions for any of these items does not need to be in document form.

Appears content is missing from this file. Only values in final two columns

Artefacts you deleted are in use at my company; please keep them

For all 'subcategories' whose names deviate from the the TMF RM v2.0 section names - what is the rationale for the deviation? Doing so will only make it more difficult for industry & vendors to understand this model (and therefore less likely to use it).

Filenote, General comment, It could be considered to create a Category for filenotes (xxx,yy) with a code (Txxs.yy.zz) for all types/areas instead of having a category within all sections.Filenotes could also be filed linked to the topic it relates to, i.e IRB approval, Investigator CV, etc. This is how it’s done in our organisation. List of filenotes are then placed in communications.NClt-codes: C115531,C115547, C115546, C115548, C115550, C115549,C115506, C115507, C115504, C115509, C115505, C115508.

In the definitions (column F) there should be consistency in terms of the phraseology used. For example, ‘a description of’, ‘a documented description of’.

Investigator site artifacts are left out. This is inappropriate as per the MHRA - The TMF is normally composed of a sponsor file, held by the sponsor organisation, and an investigator site file, held by the investigator. These files together are regarded as comprising the entire TMF for the trial and should be established at the beginning of the trial.

Inclusion of the source of definitions (column F) is unnecessary e.g. CareLex, adapted from TMF-RM. This information may be useful to help reviewers during the public review stage but adds no value to the final standard.

The number of artifacts in the OASIS eTMF Standard that do not exist in the TMF Reference Model, and the number of artifacts in the TMF Reference Model that do not exist in the OASIS eTMF Standard. These have to be aligned or we will just confuse the Industry.

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies

I am very concerned about alignment between the OASIS standards and the TMF Reference Model. My company as well as hundreds of others have adopted the TMF Reference Model, we have also participated in the development of the model, and have adopted the standards from the model into our eTMF software. Significant changes from the current structure or the artifact list itself will create many additional hours of unexpected work and will also put at risk the hundreds of hours of work that were put into the TMF Reference Model standards.

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies.

I was only able to review the first couple sections. My comments in those sections are attached. Overall, it appears that there isn’t complete alignment with the TMF Reference Model (RM). There are sections that have been deleted or lumped into other categories which is not appropriate. As a user of the TMF RM, I am concerned that not all the artifacts in the TMF RM are available in the Oasis standard. Please ensure all artifacts are represented prior to moving forward with the Oasis Standard.

I was only able to review the first couple sections. My [four] comments in those sections are attached. Overall, it appears that there isn’t complete alignment with the TMF Reference Model (RM). There are sections that have been deleted or lumped into other categories which is not appropriate. As a user of the TMF RM, I am concerned that not all the artifacts in the TMF RM are available in the Oasis standard. Please ensure all artifacts are represented prior to moving forward with the Oasis Standard.


As mentioned by others...it is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies.

It is critical to get alignment between the OASIS eTMF model and the TMF Reference Model since many companies have made a significant investment in adopting the TMF Reference Model, which is a product of the collaborative work of more than 350 professionals from over 200 companies.

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies.I use the reference model and have introduced this model to several companies I have consulted for. I intend to continue using it.

Many consolidated efforts have contributed to the development of the TMF Reference Model - particular gratitude to the leaders of the group and sub-groups. The TMF RM has spoken a global language to support synergy of efforts, as is anticipated for the OASIS eTMF Model. Motivations of best outcomes and greater development over the next 5-10 years are supported by the two models aligning. Other alternatives only appear to bring an opposite result.Please do count us in to support this positive step.

It is a key concern for both software vendors and sponsors that there is a fundamental alignment between the TMF Reference Model, which is in place in the large majority of eTMF implementations, and the OASIS eTMF Model to ensure that the interoperability standard can be achieved AND maintained. This requires compromise and communication across both models, as the interest isAs we have seen with the research done around eCTD, interoperability is a huge challenge and presents extreme risk for many sponsors when considering content or technology transfers.

As many companies are aligned with the TMF Reference Model, it is imperative ensure alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies and reflects the current industry needs.

It seems the TMF Reference Model and OASIS eTMF model are not well aligned, specifically, with the numbering schema. The category code doesn’t match the RM artifact #, as OASIS primary categories are 3-digit, whereas the corresponding RM zone is 2-digit; additionally, the sequencing is not matched. For example, TMF Plan in the OASIS model is T100.10.10, while it is 01.01.01 in the TMF RM. As the TMF RM is the collaborative work of over 350 people and from ~200 companies, representing Pharma, Biotech, CROs and eTMF vendors, it is being highly adopted across the industry; abandoning already existing and asking the industry to adopt new taxonomy is not recommended. Please remain consistent.

As expressed by others, it is imperative to ensure alignment between the TMF Reference Model and the OASIS eTMF Model. The TMF Reference Model has been adopted or leveraged by many organizations and represents the input and experience of over 350 industry representatives from around 200 companies.


As a vendor developing systems for managing content, records and processes in a number of areas of the Life Science value chain we are particularly interested in the establishment of standards. We have participated in the eTMF Reference model development and observed its development over the years that the group has been operating. Over this time the model has matured with experience being fed into it over time leading to improvements. It is imperative that any standards initiative builds upon this experience. OASIS brings experience from the standards development world which can again lead to a refinement of the standard, so long as alignment is built into the process.As we as vendors look to develop systems based around the standard in order that clients can implement quicker and less expensively there is only one thing worse than not having a Standard to work with and that is having more than one Standard to choose from !Over time it can only lead to fragmentation in the initial phase and then wasted effort across the industry until alignment or victory is achieved within the standards world. Let us learn from the past lessons of duplication of effort and build in that alignment from the beginning. There is then a better chance of achieving a universal standard to move forward with. That way vendors of systems can avoid the dilemma of having to select the path to take and clients/implementers can be less concerned about picking the “Betamax” equivalent and having to change later on.

While I agree with the objectives of this project, it is important to note that many of us are using the TMF reference model. It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies. If you do not align to the model, those of us who created systems based on the model will be out of sync. Impact major


We think it is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry or reference in the OASIS Model. This is important for the overall standardisation and the consistency of content across the respective models. The TMF Reference model is the collaborative work of over 350 people from around 200 companies and because of that worth to be recognised for any other standardisation initiatives.

‘It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies’


Please remember that when authoring this specification document and matching industry vocabulary, that it is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artefact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies, and is implemented in slight variations within many CRO, Biotech and Pharma companies. The impact that this specification would have on the eTMF systems currently in place needs to be considered more carefully and with more in depth research.

We believe that any interoperability standard for eTMF should begin with the work of the DIA Reference Model as many companies have built their TMF structure around it. The Oasis initiative has not gone down that route and appears is focused on detailed technical specifications without first aligning with the business requirements.


The momentum behind the TMF Reference Model from contributors and users within all walks of our industry, combined with the positive feedback being generated from regulatory agencies, leads me to suggest that a technical interoperability standard really must be aligned with this widely adopted model. In order to be viable in practice, the OASIS model must take into account the collaborative work of more than 350 hands-on experts representing 200+ organisations.

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies – this was an important effort and to throw this consensus away for no apparent reason is inefficient and inconsiderate to those involved.

It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model, so that for every TMF Reference Model artifact, there is a related entry in the OASIS Model. The TMF Reference model is the collaborative work of over 350 people from around 200 companies’

Regarding “The TMF Reference model is the collaborative work of over 350 people from around 200 companies and because of that worth to be recognised for any other standardisation initiatives.” VERY TRUE. TMF Reference Model has been my back bone for all the studies that I have been working on from the time it was launched. I call it “ TMF-Bible” .


As the Chairman of the TMF Reference Model Steering Committee and the co-Chair of the TMF Reference Model, I am writing to express my overall concern regarding the lack of alignment between the TMF Reference Model and the OASIS eTMF Standard.The TMF Reference model was born out of a DIA special interest group in 2009, and has released versions 1.0, 1.1, 1.2 and 2.0 since then. Number of individuals who have ever been on the TMF Reference Model = 454.Number of currently members who are part of the ongoing communications= 364Total number of companies represented since inception = 203Companies represented listed below:Aastrom, BD, Clinipace, Eli Lilly, Genzyme, ISI, Mcdougall ScientificParagon, QC2, Shire, United Therapeutics, Abbott, Biogen Idec, Cognizant, EMA, Gilead, J & J, Medidata, Parexel, Quanticate, Sidley austin, URL Pharma, Abbvie, Bioventus, Consultant, EMC, Janssen, Medimmune, Peter MacCallum Cancer Centre, QuintilesSite - Australia, Veeva, Actelion, Bluebird, Cordis, EMD Serono, Glemser, Medi-San, Pfizer, Rammell Consulting, Smith & Nephew (devices), Vernalis, Adamas Consulting, Boehringer Ingelheim, Corementum, Endocyte, Global Clincial Conenctions, Kanglaite, MedNet Solutions, Pfizer, Regeneron, Solvay, Vertex, Advance research associates, Covance, ePharma Solutions, Grunenthal, Kendle, Medtronics, Pharma Compliance, Registrat-MAP, Spectrum, Wingspan, Akros Pharma, Cadence Pharmaceuticals, CRIX International - Quintiles, Epson & St Helliers NHS Trust, GSKKids Research Inst, NSW, Merck, Pharmacovigilant, Riverdale Assn, St Vincents, Melbourne, WIPRO, Alexion, Cambridge Cognition, CSC, eRegulatory Submission, GXPi, Kings College, MHRA, Pharmanet, Roche, Stem Cell Therapeutics, WWCT, Alkermes, CareLex, Cubist Pharmaceuticals, Harrison Clinical Research, Kingston Consulting, Millenium, Pharmavigilant, Royal MarsdenSterling Bio, Xoma, Allergan, CE3, Cytrx, Ethicon / J&J, Helicon Therapeutics, Leo Pharma, Mission 3, Phlexglobal, RQ2, SunovianXybion, Alnara, Celerion, Daiichi-Sankyo, FDA, Highpoint SolutionsLife Sciences Integration Partners, Mitsubishi, Photocure, Sacura, Syntax, Zymogenetics, Amgen, Celgene, Dainippon Sumitoma, Ferring, Human Genome Sciences, Eli Lilly, MMRX, It is imperative to get alignment between the TMF Reference Model and the OASIS eTMF Model.


The TMF Reference model represents the collective input of over 300 subject matter experts at large and small Pharma, CROs, and vendors. The model was developed with a vision in mind to accomplish the following:- improve collaboration related to drugs co-development- enhance interaction with health authorities during regulatory inspections or approval- simplify data exchange operations between sponsors and service providers- introduce efficiencies in Trial Master Files management- Establish a scalable standard applicable to paper and electronic TMFsAny deviation or misalignment with the TMF Reference Model V2.0, should be rejected. Since it will undermine the work of many professionals affiliated with over 200 organization and will for certain lead to minimal adoption. It is my hope, the OASIS team would reconsider the interoperability approach and adopt the TMF Reference as the foundation. I believe the initial work is encouraging, but we need OASIS to commit to maintaining alignment with the TMF Reference Model throughout the entire development process.

Wanted to provide feedback on the OASIS eTMF Model and ensure that the Model aligns with the TMF Reference Model artifact description and detail, as the work of the TMF Reference Model has input from over 350 folks across the industry and is regarded highly in the work that we do every day with trial master files.

General Comment – The word Trial is used across many terms. Not all projects within the pharma/device space are trials. Some projects are studies.

Trivial - The links for Oracle and CareLex under editors on the cover page are redirects, as is #13 under 1.3 Non-Normative References. The link checker at: http://validator.w3.org/checklink reports as follows: ***** Line: 1369 http://bioportal.bioontology.org/ontologies/3008/?p=terms redirected to http://bioportal.bioontology.org/ontologies/CARELEX?p=classes Status: 301 -> 200 OK This is a permanent redirect. The link should be updated. warning Line: 932 http://www.oracle.com/ redirected to http://www.oracle.com/index.html Status: 301 -> 200 OK This is a permanent redirect. The link should be updated. warning Lines: 919, 925, 928 http://www.carelex.org/ redirected to http://carelex.org/ Status: 301 -> 200 OK This is a permanent redirect. The link should be updated. *****

What if a document is associated with multiple sites? Is this accommodated?

I may have missed this, but I don’t see any place in the message for envelope information such as Date created, Entity creating message, System of origin, Comments on status or purpose of message (e.g., “Final Archive of Trial XYZ”, “Monthly Trial Update for Trial ABC August 2014”, etc.)

Overall Comment: Understanding how the references tie in with the standards proposed, a 45 day review period is not sufficient to provide a comprehensive and constructive review of the documentation. Suggest sub committees to be established for sections 4-7 with representatives from across the industry to provide both technical and business input to enable a robust standard for the portability of TMF documentation.

Most modern eTMF applications allow for content placeholders and some allow for these placeholders to be fulfilled (finalized) without content. Model does not seem to handle this.

Column A – It has proven difficult for reviewers to immediately differentiate category, subcategory and content types, as all three are identified with the code [C] for Category. It would have been easier to navigate the spreadsheet if three different codes were used.

To facilitate interoperability, a hierarchy of category, subcategory and content type is not necessary. A classification system is already available for industry to adopt, namely the TMF Reference Model. All that is needed for interoperability of content types is the use of a unique identifier for each content type with this identifier being used consistently by adopting systems. For example, code C115777 is a Quality Plan. So long as subscribing systems use the code C115777, the category and subcategory is irrelevant, as is the positioning of the content type within a classification hierarchy. The classification should be defined by each system.

Apply consistency in the level of granularity provided. Some taxonomy has a deeper content classification whereas other areas have broader content types and attributes to distinguish further; The different image types for example should not be separate artefacts

There is no mechanism for deleting a document that was previously sent.

Tracking Documentation, What is supposed to be filed there. Is it the outcome or the tracking itself, i.e. also a database? "It could be considered to create a Category for tracking (xxx,yy) with a code (Txxs.yy.zz) for all types/areas instead of having a category within all sections.NClt-codes: C115656, C115658, C115637, C115638, C115724, C115666, C115480, C115692, C115781, C115670, C115706, C115704, C115727, C115728, C115640, C115641, C115742, C115748, C115681, C115684, C115729, C115730,

The MHRA, EMA and FDA GCP Inspectors have reviewed and commented on the TMF Reference Model. The principle of the TMF Reference Model has been incorporated into the MHRA Grey guide chapter 10 and the EMA reflection paper.The organisation of a sponsor file can become quite complex, especially when the trial is multinational or multi-centre. Typically documentation is organised in the sponsor file at three levels. This approach is recommended as it allows particular sections of the TMF to be made available upon request, although amalgamation of the files may be a more suitable approach if, for example, a single-country trial is being performed (with combination of global and country-level files) or when running a single-site trial, where all three levels can be combined.The OASIS eTMF Standard does not accommodate artifacts (preferred terms) at these 3 levels, there is no country level. From my vast TMF experience, I know that not having a country level place to file does not work. It makes the eTMF unwieldy and difficult to navigate. In addition, many items can be at trial, country or site level e.g. protocol amendment. This cannot be accommodated in the OASIS model.

What is the expectation on how cross-study documents such as safety documents, IBs, or master contracts are handled? Is the same document submitted for multiple studies?

How do you handle unblinded documents and restricted documents such as contracts?

Page 34 – Question: What about DICOM, MP3, MP4, PET scans? How is this handled?

Where are field details defined (data types, max lengths, etc.)?

Is there a hash or checksum for file content?

Thank you for progressing this important topic. While I support the definition of a technical (IT) standard to exchange document information, I feel the contextual standard, (e.g. attributes and naming conventions), should not be part of the standard. Your work should focus on the interface, (e.g. API), which any system can use to exchange information with any other system which supports the API. This approach will provide the most utility as we could then readily transform legacy TMFs to any target that supports the API. This could be used for submitting to different agencies, sponsor mergers, sponsor partnerships, contribution to a ‘universal’ TMF…This also decouples the transport layer from the data itself which provides the best flexibility and ability to change over time.

Monor - Hanging paragraph occur at sections 1, 2, 3, 5, 5.1, 5.1.1, 5.2, 5.2.1, 5.2.2, 5.3, 6, and 6.1. A "hanging paragraph" is one where you can't determine what is included if you say: Section 2, for example. Section 2 in this draft is followed by text and then section 2.1. If I say Section 2, do I mean the text between Section 2 and sub-section 2.1 or do I mean all of section 2? A reader cannot tell for certain so it is best to re-write the sections so that references are clear. For example: 2. Problem Definition 2.1 Background 2.2 Issues solved by eTMF (for example) with no text between 2 and 2.1, the reader can clearly reference either 2.1 or 2.2, or both, by saying Section 2. Issue: Bug Key: TAB-1043

Minor - Incorrect subsections appear at: 2 -> 2.1 3 -> 3.1 4 -> 4.1 5.1 -> 5.1.1 5.2.1 -> 5.2.1.1 5.2.2 -> 5.2.2.1 In order to have a subsection 2.1, there must be a subsection 2.2 (or more). If there is only one subdivision, re-write the text to incorporate the subsection. Issue: Bug Key: TAB-1044

Dublin Metadata – Comment: this is outdated and does not reflect an electronic environment. For example, they have 2 examples of images, 1) Image, and 2) Still image. We deal with a myriad of types and it is important to delineate them in order to determine the size and complexity of what we are dealing with. PDF’s and JPEG are not the same to handle as complex DICOM or PET scans. Dublin could be used as a baseline, but the content needs to be seriously updated to reflect the status changes, and granularity that electronic systems can provide. Too high level for reporting purposes in today’s environment.

Is there an expectation about whether a single message represents an entire trial or can it be partial? Can these messages be sent throughout the course of a trial with incremental updates or new complete snapshots?

I have to bring this up, something is bothering me, what tomorrow if Oasis is dissolved or taken up by a new company, then we all will be back to Zero, start all over again.What will be our next step if this happens? One request , Just keep it as aligned and consistence as possible. [Portions of the comment not included are duplicative of https://lists.oasis-open.org/archives/etmf-comment/201408/msg00065.html]Any change (deletion, change, addition) must have good business rational. Please provide the rational as expected in a managed standard change management process

I note that the draft specification does not appear to include attributes that would assist in the long-term retention, preservation and ultimate disposal of the record. For example, the British Standard BS 23081 ‘Metadata for Records’, the UK National Archives ‘Records Management Metadata Standard’ and the Australian Government ‘Metadata Standard’ all include attributes for archiving, retention and disposal. Whilst there is not a global/international standard or vocabulary equivalent to NCI for such terms, I would suggest including some relevant attributes from PREMIS which is the nearest thing you can get to a standard. The PREMIS Data Dictionary for Preservation Metadata is “the international standard for metadata to support the preservation of digital objects and ensure their long-term usability” As an absolute minimum, the specification should include use of a hash sum to monitor record integrity!The retention times themselves would not be appropriate to include but there should be mandatory attributes that support retention/disposal management as well as digital preservation.

Spreadsheet and XML have numerous references to Carelex. This does not seem appropriate

Open system standards- Question: Who has ownership regarding the review and update process? What is the conflict resolution procedure? And what is the frequency of the review/update?

I don’t see any place in the model to transfer information about the trial and sites. E.g.: STUDY: Name, Description, Phase,Type, Milestones,Therapeutic area, Status (on-going, terminated, closed, archived, etc.), etc.; SITE: Institution, Country, Address, Status, Milestones, etc.;

How do you capture document relationships tracked in many systems? How do you handle translations?

I really think this model would benefit from defining detailed use cases. For example:• Ongoing / periodic transfer of documents from a CRO to a sponsor• Final transfer of documents from a CRO to a sponsor for a completed study• Transfer of documents originating at a sponsor to a CRO• Export of a final study for archiving in accordance with records management policies• Transfer of documents from a regulatory EDMS to an eTMF• Upload of site documents (or vendor documents, etc.)• Transfer of a paper TMF to an eTMF• Transfer of documents from a legacy eTMF to a new eTMF• Export of documents to support regulatory publishing• Etc.

It is noted that another respondent refers to ‘use cases’ for the eTMF Standard, including the exchange of eTMF content to a location for long-term archiving and preservation. Such a ‘use case’ would require retention, preservation and disposal-related attributes to be effective. [see118-CSD1]

Comment: Standards should be objective and as inclusive as possible in order to promote compliance. The OASIS standard needs to produce use cases that will support industry adoption. The lack of use cases will result in the standard drifting, as the true owners (sponsors) will not be able to internally provide justification for the initial and on-going cost of ownership. SOP’s, work instructions etc. will have to be re-written, training will have to take place on a global level - the case that cost reductions will come is understood, however without providing metrics, falls into the greater good category, which is difficult to defend within sponsor’s financial reviews.

The technical specification is going in a beneficial long-term direction! The content model however, raises severe concerns.General observations: The TMF Reference Model has been developed by over 350 industry experts and has been implemented in numerous systems; There is no clear justification provided, why we should switch to another content model. My company’s application which is based on the TMF reference model does not provide the flexibility to easily switch between models – like probably most applications in use in the industry. We also have integrations with the

How do you recommend handling fields containing user names when those users do not exist in a receiving system?

How do you account for the fact that the same doc type may exist at multiple levels (e.g., an informed consent)

Unless I have overlooked it, the specification does not provide for a tracking/logging mechanism for multiple or sequential exchanges of TMF content. For example, System A might transfer TMF content to System B at regular intervals throughout a clinical trial e.g. monthly. The specification should include metadata that tracks whether a specific object has already been transferred in a prior exchange and whether the object has changed in the source system since being transferred. This omission may have resulted from the lack of use cases within the specification?

Major - There are 19 figures that appear before the conformance clauses. Some use the word "example" in their captions but others that don't, are clearly examples as well. Issue: Bug Key: TAB-1053

It is noted that whilst the specification and vocabulary allows for trial-level documents and site-level documents, there is no provision for country-level documents other than using the “country” metadata attribute. In other words there is inconsistency within the specification; country-level documents are classified using “country” metadata whilst site-level documents have their own subcategory (104.11).

IRB / IEC and other committees: · All trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) are being considered a single artifact/content type – this will be a critical Regulator finding on Inspection as they will not be able to easily differentiate between submissions and approvals and communications, apart from with document level metadata. This goes against the principal of the TMF Reference Model – a model used and agreed between over 350 people now. The TMF Reference Model format must be followed for Industry standardisation. In addition, only single country studies have trial level IRB / IEC approval as an option, and then usually just single site All site-level IRB/IEC documents will be considered different content types to the equivalent trial-level IRB/IEC documents and classified within the Site Management zone rather than the IRB/IEC zone – this means there is no consistency in classification between site level IRB and country level IRB which will make searching far more complex. This could be a critical Regulator finding. The TMF Reference Model format MUST be followed as it is logical and agreed by over 350 people. There is no provision for country-level IRB/IEC documents – This goes against the basics of the clinical trial process as there is very often country level ethics committees. This needs to be broken down to separate artifacts as per the site level Ethics artifacts. This could be a critical Regulator finding. An “IRB/IEC-approved” ICF is considered a different artifact to the master ICF submitted to the IRB/IEC. The same applies to subject diaries, questionnaires, information sheets, subject participation cards etc. Approval of a document is more usually considered a property of the document (metadata) rather than changing the content or artifact type. This is completely unmanageable as a concept – version 1 will be finalised at a trial level, then maybe at a country level, then maybe at a site level. They will all be masters, they could all need EC approval. Approval would be an ongoing process, so documents would have to be copied from the master location to the approved location as they are approved. What happens if a trial master is approved at half the sites but not all sites? Does it go in the approved artifact? If it is stored at site level, you could have multiple copies of a single document being stored. I radically oppose this idea, it is totally unworkable in real life.

My company has been successfully using the TMF Reference model for several years with all of our CROs. Please consider the following: · OASIS considers all trial-level IRB/IEC documents (other than meeting materials, file notes and tracking documents) as a single artifact/content type. IRB documents at the trial level contain several easily identifiable types of documents and they should remain broken out.· OASIS allows all site-level IRB/IEC documents will be considered different content types to the equivalent trial-level IRB/IEC documents and classified within the Site Management zone rather than the IRB/IEC zone. Please keep this as IRB documentation – as it is a specific category on its own.· OASIS has no provision for country-level IRB/IEC documents. This is critical for global studies as certain countries have a central IRB for the study and local IRBs for the investigators. They need to remain. OASIS needs to clarify the following An “IRB/IEC-approved” ICF is considered a different artifact to the master ICF submitted to the IRB/IEC. The same applies to subject diaries, questionnaires, information sheets, subject participation cards etc. Approval of a document is more usually considered a property of the document (metadata) rather than changing the content or artifact type.· OASIS must clarify the following as sponsor and investigator study files must be clear – while many documents do overlap, the classification must be clear.The Site Management zone includes a section specifically for documents that relate to a specified site (“Investigator Documents”). This section contains 39 separate artifacts or content types. Outside of this section are listed other artifacts which are also site-specific i.e. inconsistent classification.

It seems the TMF Reference Model and OASIS eTMF model are not well aligned, specifically, with missing/extra artifacts or ‘preferred terms’. Here are some examples: Having all trial IRB documents listed as either a communication, tracking, meeting material and filenotes is not sufficient. There are many key documents (e.g. ethics composition) that are significant enough to warrant their own artifact; otherwise, documents become cluttered and lose their unique identity. With the new MHRA rating of critical TMF findings, this disorganization or lack of clarity would not be acceptable.It is not recommended to have IRB documents filed in different primary categories (i.e. trial as 103 and site as 104); a user would want consistency in knowing that a particular number always represents the same content typesIt is not clear why some artifacts are duplicated for primary category 104-Site Management (e.g. IRB and IP), while others exist only in their primary category (e.g. safety)Line #124 “Study Team Curriculum Vitae” this new item is not necessary. The existing RM artifacts are sufficient:01.02.02 Trial Team Curriculum Vitae05.02.04 Principal Investigator Curriculum Vitae05.02.05 Sub-Investigator Curriculum Vitae05.02.06 Other Curriculum Vitae05.02.07 Site and Staff Qualification Supporting Information Although organizations may adapt the TMF RM to their needs, they know and have documented their deviations from this core model. Introducing another taxonomy, will force significant re-work to identify gaps and deviations from the core TMF RM, to the organizations adapted version, to the OASIS standard. Fear of change and un-necessary effort will prevent adoption. [Portions of this comment not included are duplicates of https://lists.oasis-open.org/archives/etmf-comment/201408/msg00101.html]

The classification of IRB/IEC-approved documents separately from the unapproved “master” documents is not consistent with industry practice for managing these documents. In addition, the approval of a document by an IRB/IEC is a business process which can be captured using metadata….. as defined elsewhere in the OASIS draft specification. It is not common practice to manage IRB/IEC-approved documents as a document set separately from the core original documents. Subcategory 104.13 is named “IRB/IEC Documents”, with an equivalent definition. However, it includes 2 documents (104.13.22 and 104.13.23) that are not IRB/IEC documents. This is inconsistent. Either the subcategory should be renamed or an additional subcategory should be created.

Important artifact in the TMF for Device studies.

Meeting material, General Comment,It could be considered to create a Category for meeting material (xxx,yy) with a code (Txxs.yy.zz) for all types/areas instead of having a category within all sections.NClt-codes: C115601, C115597, C115612, C115609,C115603,C115610, C115613, C115598, C115615, C115607, C115614,

in use at Janssen, do not remove

I see no Subcategory for Ongoing / interim Monitoring and study Close-out Monitoring in Category 104-Site Management. Several of the study conduct Monitoring Report Content Types (C115577, C115536, C115737, C115664, C115648, C115581, C115673, C115537, C115538, C115581) are incorrectly classified under Site Set-up Documentation (Category 104.11), and should have their own subcategory following Subcategory 104.12 (Site Initiation/ Training) 241 Monitoring Visit Follow-up Letter (under review) would fit in Category 104 with these documents as well.

Investigator site artifacts are left out. This is inappropriate as per the ICH Guidelines and MHRA - The TMF is normally composed of a sponsor file, held by the sponsor organisation, and an investigator site file, held by the investigator. These files together are regarded as comprising the entire TMF for the trial and should be established at the beginning of the trial.


Last page, item 'Industry Review Needed' with TMF RM Term 'Monitoring Visit Followup Letter' It is inferred that the proposed model consolidates this TMF RM artifact into the 'Monitoring Visit Report' content types? Is this true? If so, is there a rationale for this? ICH E6 has them as separate documents. Recommend keeping them separate.

Important artifact in the TMF. Expressly requested by TMF community to be called out uniquely from other communications with the sites.


Important artifact in the TMF, the investigator portion of the TMF.

Line 397, RM 241, Monitoring Visit Reports, Follow-upTerm: Monitoring Visit Follow-Up letterSynonym: "MVR Follow-up, MVR FU"Abbreviation: "FU, MVR FU"Definition: "To document site visits monitoring trial conduct and compliance of the site, including site visit follow-up letter."Comment: Suggestion to text. Should absolutely be part of the model. Should be connected with Monitoring Visit reports

in use at Janssen, do not remove; This is required documentation following a monitoring visit.


Important artifact in the TMF. Required by MHRA and a very comment artifact in the TMF.

Line 391, RM 236, Risk Management Plan Term: Risk Management PlanSynonym: Risk analysis planDefinition: "To document identified potential risks that can occur during the clinical programme/trial lifecycle." Comment: Suggestion to text. Should absolutely be part of the model


in use at Janssen, do not remove (Source Documentation Idenification Form)

Line 391, RM235 Comment: Source Data (enrollment log and screen log) are described in C115537 and C115538. What else should be included as source?

Line 116, RM 106 Source Data Verification Should be included.Definition: To document source data and associated verification activity Comment: In our organisation we use SDV agreement form and we have a tool to plan and document for Risk Based Monitoring. This section should be in the OASIS model

Important artifact in the TMF; important for EDC studies.

in use in vTMF

Column I, row 116 Source Data Verification. This is information is included in the monitoring visit report. Consider deleting.

Important artifact in the TMF; not a subject screening log as indicated as a synonym to.

Line 390, RM 234 Preferred term: Subject Identification LogSynonym: Subject Identification Code ListDefinition: To fully identify all subjects screened, screen failed and enrolled in the trial, with unique institution identifiers where relevant Comment: Enrollment log and screening log) are described in C115537 and C115538. Screen failed log is not described elsewhere.

duplicate; TMF RM:105

Line 398, RM 245, Technical Design DocumentsTerm: Technical Design DocumentsSynonym: "Configuration SpecificationsDefinition: Document containing the design elements of the eCRF including the variables to be collected, the logical arrangement of the variables, navigation among and between the different forms, the logic checks for logical consistency.Comment: Suggestion to text. Should absolutely be part of the model.


If possible, recommend to add these to the eTMF list since they are sometimes provided / required to be in the sponsor's TMF: 236 Risk Management Plan --> Subcategory 100.10237 Vendor Management Plan --> Subcategory 100.10238 Device Review Committee --> Subcategory 100.12 239 Report of Prior Investigations --> Subcategory 101.10 (device trial document analogous to the IB for clinical trials)240 Investigators Agreement (Device)-->Subcategory 104.11 (= Investigator's Contract)245 Technical Design Document --> Subcategory 109.12


Important artifact in the TMF. Required by MHRA and a very comment artifact in the TMF.

Line 392, RM 237, Vendor Management PlanTerm: Vendor Management PlanSynonym: Outsourcing planDefinition: "To document overall management strategy for vendors used to conduct trial-related activities. May include assignment of responsibilities for vendor oversight, performance indicators, monitoring activities and schedules, issue escalation and resolution process technology and documentation transfer, and business continuity plan."Comment: Suggestion to text. Should absolutely be part of the model


Suggest to add new item unless it is already covered somewhere: CRO Oversight Plan


Line 167, Add term X_____ IP Device Maintenance LogNo comments

Line 166, Add term X__ IP Retest and Expiry Document No comments

agree with artifact name change [TMFRM 242]

Line 124, X______ NEW: To be submitted. (Curriculum Vitae C54631 too general for our definition)CVs of sponsor employees are available elsewhere and should not be copied into several TMFs.Definition should be changed to not to include Sponsor CVsConsideration: How can i.e. Investigator CVs be found for submission at a later stage - they will as this be mixed will all other kinds of CVs.It could be considered to create a Category for CVs (xxx,yy) with a code (Txxs.yy.zz) for all types of CVs instead.

eTMF.owl: Reference to Carelex shall be removed.

If this will be added, "Study Team" is too general a term and could have confusion as "study team" exist at some many levels. May also allow duplication of PI and SI CVs here too. The definition even allows it! I still think TMF RM term is mostly right as well as the definition "To document qualifications and eligibility of site personnel other than the Principal Investigator or Sub-Investigators to conduct trial and/or provide medical supervision of subjects."

T104.11.39 = TMFRM nos. 087 (Principal Investigators), 088 (Sub-investigators) and 089 (Other site staff), i.e. all 3 artifacts.

artifact name change has limited additional benefit; are we certain that this new scope is inclusive enough?

Row 124, Preferred Term “Study Team Curriculum Vitae”; add Study Team CV to synonyms, PI CV, Sub-I CV. If using this term then delete C115487 (PI CV) and C115488 (Sub-I CV)

X______ NEW: To be submitted. (Curriculum Vitae C54631 too general for our definition) The definition for this entry is confusing. It talks about both site and sponsor personel. Sponsor CVs are listed in C115489. Are you saying there is a difference between a study team and a trial team?

eTMF.owl : <owl:DatatypeProperty rdf:about="&etmf;eSign_Status"> An indication of whether a document or Content Item has been digitally signed. We re only captriung digital signature status . What about electronic signatures. And also we are not capturing essential properties of signatures like date time, signee and reason for signature.

eTMF.owl : <owl:DatatypeProperty rdf:about="&etmf;Format"> Value_Set does not covers many other file formats that could be in eTMF.

The user fields such as Modified_By below states as the username of the person. Would it be better to have email address of a unique person identifier for interoperability purposes[?] <owl:DatatypeProperty rdf:about="&etmf;Modified_By"> <Definition rdf:datatype="&xsd;string">Indicates the username of the person who changed an item. [CareLex]</Definition>

eTMF.owl: <owl:DatatypeProperty rdf:about="&etmf;Modified_By"> Definition says username of the person. What value does username provides for interoperability. Username of one application may not mean anything in another if they are not using the same source. Moreover, in my opinion it is a security risk to send usernames until some security protocol is followed. Would suggest use of some other identifier e.g. email address,

eTMF.owl: <owl:DatatypeProperty rdf:about="&etmf;Modified"> The date and time a digital resource was changed in ISO 8601 format. We should stick to UTC format only as ISO 8601 defines two ways of handlijng timezones.

Page 10: "Support for the DIA TMF Reference Model..."Why was the TMF RM not used as the source here, given its level of adoption and awareness in industry? Beyond cross-referencing, the OASIS model should stay in lockstep with the TMF RM to reduce industry confusion.

The classification of content within category 104 is inconsistent. Subcategory 104.11 includes content which is pertinent to a specific site ad yet content in other subcategories is also pertinent to a specific site only e.g. trial initiation monitoring report, investigator confidentiality agreement, approved consent forms. Subcategory 104.11 includes 39 individual content types. Although it is understood that the classification schema is a technical classification and not necessarily an end-user interface classification, it would make sense to use a subdivision that resulted in smaller groupings of content, as the TMF Reference Model has done.

[no comment attached or in body of email. Sender notified.]


These TMF documents are filed only at the Investigator Site (ISF only)- not needed unless you are also planning for e-ISFs / (should not be filed in the sponsor's TMF files): 234 Subject Identification Log235 Source Data

Table 3. None of metadata types can be reserved. Is it correct (i.e. Domain-specific)?

Table 1 and Tables 3,5 contradict one another: Table 1 says ‘Organization-specific term has no Term Source URL’, Tables 3,5 say it can have.


Add synonym "Vendor Oversight Plan" which was removed from C115777

C80447 – include electronic signature as well



Duplicate of https://lists.oasis-open.org/archives/etmf-comment/201408/msg00113.html

All contents in this comment (link) are duplicates of comments contained in https://lists.oasis-open.org/archives/etmf/201408/msg00007.html

Duplicate entry. See https://lists.oasis-open.org/archives/etmf-comment/201408/msg00091.html

Submitted Comment Souce Submit By

Source Type

E. Rammell C

P. Durusau TAB

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<A link to the oasis-charter-discuss@ email or emails providing those comments should go here>

V=vendor, C=consultant; O=clincal ops; S=sponsor; R=CRO;

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https://lists.oasis-open.org/archives/etmf-comment/201408/msg00054.htmlM. Wallstein MD










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Issue Status

Resolution status INDICATED BY COLOR: Draft Workgroup text or background info (black) Resolution Proposed by Workgroup (orange) Final Resolution voted by TC (green)

<A statement of the proposers decisions on how to address the comment should go here.>

This Specifcation is designed for use by application developers who wish to design interoperable systems for the eTMF domain. However, it is built on global internet standards, the foundational components of the specification will support other clinical trials domains as well. Action: Clarify in the introduction that focus is on eTMF domain.

Add TMF RM as a non-normative reference. Although the Specification does not directly draw from the TMF RM, CareLex's work with NCI does reference TMF RM. Action item: Please review all non-normative references.

No action. This is a common practice iwthin technical standards development and indicates to the application developers what is required and what is useful, but not required.

One of the solutions which the Specification will support is CMIS, which provides general mapping to any file folder system.

A. Change term 'Enterprise' in first paragraph of 2. Problem Definition, to 'Electronic' to match reference in section 2.1, 2nd paragraph. B. Insert reference to difficulty of content exchange between CRO-Sponsor systems in 1st paragraph. Action 1: Aliaa please review use of electronic vs. enterprise term; Action 2: expand the prob statement to include system to system interoperability; add an example of a common problem (ex: CRO and sponsor both having different systems / schema, can't communicate)

Issues: 1) Use of the term archive 2) An eTMF system may not be suited for long term archive of 25 yrs; Proposed action 1): Relabel the term 'Archive' in its first use in the spec to digital archive, followed by reference to the term as 'archive'. The term digital archive is from NCI [Digital Archive (Code C114463)]; review uses of term archive throughout spec to ensure consistency.; clarify the use of the term digital archive - is not intended to support any specific storage format; Proposed action 2): Clarify what we mean by a digital archive, its not intendend to conflict with the EU regulatory definition. Beyond the scope of the spec - The format and the media that the archive is stored in is up to the implementing org or regulatory agency.

Add clarifying statement on the scope of the content being limited in this spec to eTMF domain.

Proposed text change: From: 'Today, there is no standard that defines how eTMF documents and records should be formatted for electronic export'To: Today, there is no standard that defines how eTMF documents and records should be structured for electronic export

No change proposed.

Proposed text change: 'finally, any eTMF system must support government agency requirements for exported electronic records.'To: 'Finally, any eTMF system should support government agency requirements for exported electronic records.'

Suggested action- remove the word automated

The Metadata Vocabulary Layer draws on industry group terms such as the Trial Master File Reference Model.

While system details and functionalities are to be determined by application developers, the Specificaiton allows users to have as many multiples of a particular content type as desired. Each is characterized by the metadata tags, such as data, location, creator, etc. as well as through use of versioning.

The Specification DOES assign a minimum set of metadata to each content type and it DOES allow organizations to add organization-specific and domain-specific metadata. The three digit numbers used in TMF RM are unique identifiers, but they are not machine readable. Since this is a specification for the digital environment, they are not useful.

The Technical Committee will determine it's process for updating the CCS and Metadata Vocabularyfor future versions of the Specification. In any case, the process will be open and pubic.

No action. The TMF RM terms were used as a starting point. However, they were modified where they did not meet controlled vocabulary standards, as the goal of this specification is to accommodate the eTMF domain but domains of clinical trials as well.

No change. THe Association for Information and Image Management (AIIM) states that a content type is one of the primary building blocks for designing an enterprise content and records management system in SharePoint. Gaining an understanding of what is a content type, how is it created and configured, and what is its relationship to metadata, will enable an organization to begin the critical first steps in planning a system.

Correct Subcategory Preferred Term (100.10) to 'Trial Operations' not 'Trial Oversight' & correct figures 6, 7, 8, and 9.

Change as indicated in red or stricken: "An example is the name “100.10 Trial Management” assigned to a Primary Category, where the first part in the number sequence “100.10” reflects the Category Code, while the second part in the sequence represents the Category Subcategory Code and associated preferred term Name, “Trial Management Operations”.

The purpose of this specification is to develop a standard based upon standards for clinical trial eTMF Systems AND allow for application developers and and their customers of such eTMF systems to tailor systems to their needs. Just as the Specification allows flexibility as to the type of operating systerm, computer language, or software applications used, the Specification also allows organization-specific modifications.

As with the entire specification, these are instructions for the application developers, not for clinical operations professionals.

Proposed change: Add text that states 'If organizations decide to create org specific data, then the organizations involved should mutually agreed upon the terms' (or something similar). Another possible clarification - if org specific metadata (or content model schema) is added, its not required that receiving orgs accept the metadata.

No Change. Figure 12 is accurately referenced.

Proposed change: from: 'As illustrated in the figure, the use of dissimilar metadata terms inhibits efficient search and decreases productivity, while the use of similar terms enhances search efficiency and business productivity'to: 'As illustrated in the figure, the use of dissimilar metadata terms inhibits efficient search and interoperability (delete: decreases productivity,), while the use of a controlled vocabulary enhances search efficiency and business productivity.'

Proposed change: from: 'Finally, in order to allow for a flexible model..To: Split this bullet in two bullets, one for org specific, one for general.

In case of Organization-specific metadata terms, the details of these terms (i.e., values of annotation properties) are user-defined with exception to Code annotation property, which is generated locally.

This is not within the scope of a technical specification. This is to be determined by the application developer.

Add text,'such as' prior to refernce to XML and PDF. See Specification sections 1.2 Normative References & 6.1.1. The Specification requires use of the IANA Media Types Standard, which includes 1,080 other media types, including MS Office, MPEG audio, MPEG Video, DICOM, etc. http://www.iana.org/assignments/media-types/media-types.xhtml

Add text,'such as' prior to refernce to XML and PDF. See Specification sections 1.2 Normative References & 6.1.1. The Specification requires use of the IANA Media Types Standard, which includes 1,080 other media types, including MS Office, MPEG audio, MPEG Video, DICOM, etc. http://www.iana.org/assignments/media-types/media-types.xhtml

Add text, "...common file formats such as of XML and PDF”

The Specification allows for export of content types for preparation of the eCTD Submission format. The metadata term 'eCTD Item' can be applied to any content item by selecting 'yes, rather than the default 'no' setting. Exact process will be defined by each application developer. Exports are in XML format.

See Specification sections 1.2 Normative References & 6.1.1. The Specification requires use of the IANA Media Types Standard, which includes 1,080 other media types, including MS Office, MPEG audio, MPEG Video, DICOM, etc. http://www.iana.org/assignments/media-types/media-types.xhtml

Proposed change: In spec, clarify in sect 6.1.2 (see fig 17) the differences between the two exchange systems: eTMF Live exchange format for realtime/cloud, and eTMF exchange package for zip or for offline.

Compression: We support the standard published zip format [insert ZIP spec here ] Omit the . before the term zip just refer to it as ZIP.

Proposed: Eliminate sentence “However, the signing party cannot be easily verified.”

The specification builds in allowances for both electronic and digital signatures. Application developers (vendors) will dictate what level of signature is implemented, not this specification.

Please review term 'digital signature' term ID: C80447. Digital Signature metadata details are provided in the URL of the x.509 certificate pointed to by the metadata value for digital cert. It is up to the application to decide how to display this data or how to implement it if desired. For purposes of this spec, an electronic signature is defined as a mark or graphic image on an electronic document such as a scanned document with a signature, or a faxed document with a signature. These types of electronic signatures are supported by FDA and EMA today, and no additional metadata is required for these types of electronic signatures. Adding additional metadata for electronic signatures on scanned or faxed documents is outside of the scope of this spec. (we need to add something like this to spec, and ask Peter Alterman for clarifying thoughts). Application developers may add additional metadata regarding electronic signatures. If an org elects to use digital signatures, then mandating the capture of electronic sig metadata is an unnecessary burden and captures redundant information.

Proposed change: In the context of the OASIS eTMF standard content model, digital certificates are used to sign electronic documents. Statement ' “digital signers are validated every time they sign” will be qualified to state 'Digital signatures will be validated in accordance with x.509 digital certificate application standards regarding the requirement for passwords to be used for digital signing.' or something similar. (Peter Alterman - comments?) Specifying security or password policies is outside of the scope of this doc.

Proposed: Spell it out RSA is a public key cryptography algorithm named after its inventors (Rivest, Shamir, and Adelman). The RSA algorithm is the most commonly used encryption and authentication algorithm and is included as part of the Web browsers from Netscape and Microsoft, and many other products. (Oracle)

This Specification does not mandate whether electronic signatures, digital signatures or even wet signatures on scanned documents are used, rather the Specification makes provisions for all . It is up to each application developer to determine what functionalities are made available through their software or SaaS products.

No action. The Specification is based on the ublic Key Infrastructure (PKI) X 509

For clarification: The focus of the TC with respect to vocabulary is on content, not processes. Its beyond the scope of this version of the spec to recommend or specify a vocabulary for processes or tasks. The naming of processes and tasks is the purview of application developers and system implementers.

The Business Process Model will indicate with the process name and task name(s) within the Process. It is up to the application developers to determine the process names and process flow. This information is used within the context of Business Process Modeling Notation 2.0.

Change text from: 'd) If the eTMF Content Classification System is used for any application where ‘individually identifiable health information’ is captured, stored or transmitted, US Department of Health and Human Services HIPAA privacy regulations and compliance policies for electronic records and patient protected health information (PHI) security must be implemented in the eTMF System. For example, investigator site data may contain individually identifiable patient protected health information. System protections and data management policies for the protection of this information must be implemented to be in compliance with US HIPAA privacy regulations. 'To proposed: 'd) If the eTMF Content Classification System is used for any application where ‘individually identifiable health information’ is captured, stored or transmitted, regional, national or local regulations and laws regarding electronic records and patient protected health information (PHI) may apply. In some cases, implementations of the OASIS eTMF standard by organizations may have investigator site data with individually identifiable patient protected health information. If such protected information is included in the eTMF, then system protections and data management policies for the protection of this information must be implemented to be in compliance with applicable privacy regulations. For example, in the USA, HIPAA privacy regulations and compliance policies for electronic records and patient protected health information (PHI) security must be implemented in the eTMF System.

Proposed: The OASIS TC is open to all; specific individuals and groups that contributed to the spec were recognized. FDA/PhUSE and NCI were major contributors to the work so they were recognized. This work was in part based on TMF RM work, and this work is acknowledged under references.

ICH Def: "A TMF is the collection of documentation that allows the conduct of the clinical trial, the integrity of the trial data and the compliance of the trial with GCP to be evaluated." http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/02/WC500138893.pdfAlternative- electronic document management systems:computer-based applications dealing with the management of documents throughout the document life cycle[SOURCE: IEC 82045-1] ISO/TR 14105:2011 https://www.iso.org/obp/ui/#iso:std:iso:tr:14105:ed-2:v1:en

Core metadata is potentially applicable to every document but is not required that it have a data value.





The specification contains metadata for basic audit trail functionalities. In addition, application developers may add other audit trail capabilities. See Table 7 of B.2.

Domain based metadata listed in section B.2.2 is a sample list. The complete list is contained in the Metadata Vocabulary (spreadsheet) portion of the Specficiation.

No Change. While the focus of this Specification is the eTMF domain, the Specification is in fact being developed to enable cross domain interoperability. The Core Metadata is intentded to be interoperable with other other metadata such as BRIDG, HL7, CDISC and other controlled vocabularies. Interoperable metada also supports integration with other systems, such as CTMS and EDMS. No Change. While the focus of this Specification is the eTMF domain, the Specification is in fact being developed to enable cross domain interoperability. The Core Metadata is intentded to be interoperable with other other metadata such as BRIDG, HL7, CDISC and other controlled vocabularies. Interoperable metada also supports integration with other systems, such as CTMS and EDMS.

question regarding 'Credential' relative to security Regarding Investigator/Site Personnel ID ??? No change. The term credential is not required and is optional for any record. The term credential field is drawn from CDISC's BRIDG model and it is optionally used in eTMF content types such as PI CV. Required core metadata are noted as 'required' in the RDF/XML file. Investigator/Site Personnel ID: All content types in the Site Investigator category require Person name, Organization name identification assignments.

Additional discussion on Credentials is required by TC. Per definition, this term works.

No change. This is not a document (content type), rather a metadata tag used to identify that the noted content item may be targeted for export to the eCTD at a later date. This allows for quick identification of the documents for the eCTD, as well as rapid compilation of the documents for eCTD purposes. Note per EMA eSubmissions guidance for esubmissions document published Aug 2011, 'Guidance for Industry on Providing Regulatory Information in Electronic Format' 'The eCTD format is regarded as the principal electronic submission format in EU and is the only electronic format that is accepted by the EMA'. Please also see EMA's website where eCTD is acknowledged as the standard for eSubmissions: http://esubmission.ema.europa.eu/

No change. This is not a document (content type), rather a metadata tag used to identify that the noted content item may be targeted for export to the eCTD at a later date. This allows for quick identification of the documents for the eCTD, as well as rapid compilation of the documents for eCTD purposes. Note per EMA eSubmissions guidance for esubmissions document published Aug 2011, 'Guidance for Industry on Providing Regulatory Information in Electronic Format' 'The eCTD format is regarded as the principal electronic submission format in EU and is the only electronic format that is accepted by the EMA'. Please also see EMA's website where eCTD is acknowledged as the standard for eSubmissions: http://esubmission.ema.europa.eu/

The goal is flexibility. Allows tagging with metadata to delineate a location and country (e.g. Madrid HQ & Spain), but does not require either.

This document is for direct use by application developers of electronic systems serving the clinical trials industry, not for use directly by clinical operations professionals. It will be incumbant upon the Systems developers to properly design and build the business processes, terminology, and capabilities needed for their customer base relative to archiving standards of OECD, MHRA, EMA, and other regulatory agencies.

This term, definition and associated code is drawn from NCI, which is based upon the CareLex eTMF Domain.

As stated, versioning is supported through the W3C OWL Versioning Policies adopted in this specification. However, version management is not within the scope of this Standard, rather it is an application specific task.

No action this is out of scope, although the application developers will want to address this issue more deeply relative paper archives with relationship to electronic archives. This is a specification only for digital environments.

Use NCI preferred term 'Clinical Trial Subject Recruitment Advertisement' (Code C115462) and change Template Advertisement for Subject Recruitment' to a synonym..

Use NCI preferred term 'Clinical Trial Subject Recruitment Advertisement (Code C115462)' and change Template Advertisement for Subject Recruitment' to a synonym.

Use NCI preferred term 'Clinical Trial Subject Recruitment Advertisement (Code C115462)' and change Template Advertisement for Subject Recruitment' to a synonym.

REVIEW needed. Add Synonym: Sample Advertisement for Subject Recruitment OR Remove Template.

Hold for discussion of all IRB comments also ICF together. The proposed content types stand. The rationale is to allow for mapping with the legacy content types from the TMF RM. Going forward in future versions of the OASIS eTMF standard these content types can be reviewed.

Comment read. No action.

No change. The definition for this term the noted items without restrictive specificity. Looking into adding definitions for Clinical Supplies and Investigational Product.

Change preferred term to Site Related Confidentiality Agreement


No action. Adjudication has its own term and content type T100.12.13

Hold for discussion of all IRB comments also ICF together. The term refers to SponsorThe term refers to Sponsor-to- Central IRB direct communication and doesn't involve "Local" or Site-to-IRB communications.



New content type is being added, called 'Study Team Curriculum Vitae' T104.11.39; maps most closely to TMF RM 089. Also have content types C115487 = Principal Investigator CV and C115488 = Sub-investigator CV

Recommend keep as is, with review of Content Types under this Subcategory.

Recommend keep as is, with review of Content Types under this Subcategory.

No Change. Correct Subcategory Preferred Term (100.10) to 'Trial Operations' not 'Trial Oversight' & correct figures 6, 7, 8, and 9.


Hold for discussion of all IRB comments also ICF together.


Hold for discussion of all IRB comments also ICF together. Per ICH Change Term to Information Provided to Subjects or Non ICF Subject Information. Add Subject Information Form and Subject Information Sheet as Synonyms. Could be video or audio info in the future. (2nd mtng) Keep as is.(1st mtng)

Hold for discussion of all IRB comments also ICF together. Form = (Mirriam-Webster Def:) one of several or many different ways in which something is seen, experienced, or produced (Oxford Def): The visible shape or configuration of something. Card = (Mirriam-Webster Def:) a flat stiff usually small and rectangular piece of material (as paper, cardboard, or plastic) usually bearing information (Oxford Def): A piece of thick, stiff paper or thin pasteboard, in particular one used for writing or printing on.

Hold for discussion of all IRB comments also ICF together.

Hold for discussion of all IRB comments also ICF together. Form = (Mirriam-Webster Def:) one of several or many different ways in which something is seen, experienced, or produced (Oxford Def): The visible shape or configuration of something. Card = (Mirriam-Webster Def:) a flat stiff usually small and rectangular piece of material (as paper, cardboard, or plastic) usually bearing information (Oxford Def): A piece of thick, stiff paper or thin pasteboard, in particular one used for writing or printing on.

HOLD and review with all same code comments. Add “professional license” and “certification” to the synonyms???

This is for development of a technical appliction. The recommended specificity is too granular for a controlled vocabulary. The definition is defined in such as way to allow or disallow inclusion of such docs, based upon industry best practices.

No change. Per controlled vocabulary practices, and at NCI recommendations, terms used in the Preferred Term are best not to be used in defining the PT.

No change. Per controlled vocabulary practices, and at NCI recommendations, terms used in the Preferred Term are best not to be used in defining the PT.



Change PT to 'Trial Management Filenote'

Change Abbreviation to 'Trial Mgmt Flnote' Mgmt is the standardized abbreviation.

Add 'Note to File' in Synonym



Comment read.


This is a subcategory, see the content type C79176 'Clinical Study Report' which encompases both interim and final reports.

Form = (Mirriam-Webster Def:) one of several or many different ways in which something is seen, experienced, or produced (Oxford Def): The visible shape or configuration of something. Card = (Mirriam-Webster Def:) a flat stiff usually small and rectangular piece of material (as paper, cardboard, or plastic) usually bearing information (Oxford Def): A piece of thick, stiff paper or thin pasteboard, in particular one used for writing or printing on.




Trial Management Communications falls under a separate Subcategory.

Trial Management Communications falls under a separate Subcategory.



This is a Category name and defines the documents within this category.


No action. This content type provides the OPTION for users to use it but is not required.

Recommend no action. 'Document' delineates this is a noun not a verb. It is clarification required by NCI for controlled vocabularies. Used in other subcategories/categories: C115656, C115646, C115675, C115636

Also similar to ICH GCP.

This is a subcategory PT. See C115637, which also includes 'documents'.




Form = (Mirriam-Webster Def:) one of several or many different ways in which something is seen, experienced, or produced (Oxford Def): The visible shape or configuration of something. Card = (Mirriam-Webster Def:) a flat stiff usually small and rectangular piece of material (as paper, cardboard, or plastic) usually bearing information (Oxford Def): A piece of thick, stiff paper or thin pasteboard, in particular one used for writing or printing on.

No action. This is a category name and defines the documents within this category.




The abbreviations are only for the purpose of coding by application developers and the shorter the code the better.

Add italicized text to Def: "An itemized accounting of standard operating procedures (SOP) in effect for the duration of the trial, or any portion thereof."

REMOVE current Synonyms and ADD synonym, 'List of SOPs Current During Trial'


DELETE from abbreviations: TM Plan-C115780; ADD Synonym 'TM Plan'to C115780 ADD to abbreviations: Fin Docn-C115648; Cert Analysis-C115473;

The abbreviations are only for the purpose of coding by application developers and the shorter the code the better.

This code, preferred term, and definition was generated by NCI, not CareLex for controlled vocabulary purposes.

This code, preferred term, and definition was generated by NCI, not CareLex, for controlled vocabulary purposes.

Add ICF to Synonym. Form = (Mirriam-Webster Def:) one of several or many different ways in which something is seen, experienced, or produced (Oxford Def): The visible shape or configuration of something. Card = (Mirriam-Webster Def:) a flat stiff usually small and rectangular piece of material (as paper, cardboard, or plastic) usually bearing information (Oxford Def): A piece of thick, stiff paper or thin pasteboard, in particular one used for writing or printing on.

Add 'Clinical Investigational Plan' to Synonym

This is an NCI Code generated some time ago for use by many health science domains.


No action on this comment. Deviations from the TMF RM names resulted through development of a controlled vocabulary with consultation from the National Cancer Institute Enterprise Vocabulary Services and their bioinformatics professionals to ensure proper cross-mapping of biomedical terminology. Careful consideration was given to each existing preferred term, definition, and was screened for noun-noun agreement, specificity and clarity of description, no duplicate terms or illegal characters, and interoperability outside the eTMF domain, to name just a few elements of assessment.

This specificity pertains to development of a controlled vocabulary. Something that is documented may not be in a document format.

No action on this comment. Deviations from the TMF RM names resulted through development of a controlled vocabulary with consultation from the National Cancer Institute Enterprise Vocabulary Services and their bioinformatics professionals to ensure proper cross-mapping of biomedical terminology. Careful consideration was given to each existing preferred term, definition, and was screened for noun-noun agreement, specificity and clarity of description, no duplicate terms or illegal characters, and interoperability outside the eTMF domain, to name just a few elements of assessment.

Remove references to source, as they are listed in NCI. The source references were a reminant from the spreadsheet used for NCI.

Repeat of 323-SCD1

No action. The level of 'review' being suggeted is the very work of the the OASIS eTMF TC. Public review is for those not willing/able to do the in depth and continuous work, but who have comments to contribute. Extensive and on-going outreach to thousands of individuals representing hundreds of companies inviting eTMF TC participation has occurred from Sept 2013 to present day. As publicized, the OASIS eTMF TC is always open to those who wish to join the TC and work in depth on the OASIS eTMF Standard TC. We encourage you and colleagues to join the TC.

As noted in section 5.1, the Specification "... allows for automated sorting of content classifications and documents and has a flexible and infinitely expandable hierarchical system that can use any vocabulary or text-based terms."

This is an application-specific business process.

This is not within the scope of a technical specification. This is to be determined by the application developer, or implementing organization.

This specification supports all IANA Standard media types, including DICOM, MP3, MP4. The TC will investigate accomodating specialized image formats, including PET scans.

The specification is based on W3C standards, and does not mandate the protocol for file exchange. This is to be determined by individual application developers.

File types generated by PET imaging include .lst, .scn, .img

This is an application-specific business process.

No action.

Table 1: Rules for Creating and Editing Annotation Properties of Categories and Content Types Table 4: Rules to Edit/Create Metadata Annotation Properties Table 6: Rules to Edit/Create Annotation Properties of Annotation Properties

No action.

Date post:	14-Mar-2018
Category:	Documents
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