Views of Metadata and MetaViews of Data:
The Power of EDMS Systems
Donald PalmerAssociate Director, Regulatory Systems
February 2009
“Two thirds of Americans can't do fractions. The other half, just don't care.” - Unknown
The Road We Take – Simple?
Agenda’Data about Data’ So what?
–Metadata for Humans–Metadata for Computers
Metadata Types – Views of Metadata–Metadata Types and eCTD
MetaViews of Data–Changing Views of Documents: eCTD & Authors–EDM Metadata Issues
Summary
Content of a document is for Human use–Computers don’t understand content
Human data about content is specific to the content
Computer data is about an object, not really about the content
Human Data vs Computer Data
‘Data about Data’ So What?
Content presumes an environment in which to understand that document–Topic/Subject, Expertise, Audience
Metadata about content can be free-form–Description, Summary
Metadata for Humans
‘Data about Data’ So What?
BioPharmaceutical Pre-Market Process
(Environment)
Metadata for Humans
STDY-0123
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug.
Side Effects: Mice got ticklish.
Study: Study # CS-V4321 – 10 mg/mL in Mice for 15 days
Document Title: Study Report on Jan. 3, 05 by Barack Doe
Free-Form or Unstructured Metadata
‘Data about Data’ So What?
Computers deal with Structured metadata
Computer metadata is used to categorize documents
Documents can be placed into a structure based upon computer metadata
Metadata for Computers
‘Data about Data’ So What?
Metadata for Computers
Document
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Electronic Document Management (EDM) System
‘Data about Data’ So What?
Descriptive– Identifies a characteristic about the content
Structural–Places the content into a larger organization of
information
Process–Specifies a stage in a transformation
Metadata Types
STDY-0123
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug
Side Effects: Mice got ticklish
Free-Form or Unstructured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Metadata Types - Descriptive
STDY-0123
Doc-Type: NonClinical
Doc-Sub-Type: Safety Study
Doc-Category: Mice Study
Structural Metadata
NonClinical
SafetyStudy
MiceStudy
Metadata Types - Structural
STDY-0123
Version: 2.0
Status: Approved
Retention Date: 31-DEC-2020
Process Metadata
Draft
Review
Approved
Effective
Metadata Types - Process
STDY-0123
Doc-Type: NonClinical
Doc-Sub-Type: Safety Study
Doc-Category: Mice Study
Structural Metadata
NonClinical
SafetyStudy
MiceStudy
Draft
Review
Approved
Effective Version: 2.0
Status: Approved
Retention Date: 31-DEC-2020
Process Metadata
Author: Barack Doe
Title: Study Report
Date: 03-Jan-2005
Structured Metadata
Synopsis: Safety Animal Study concluding no problems.
Description: Animal Study using Mice and WonderDrug
Side Effects: Mice got ticklish
Free-Form or Unstructured Metadata
Object ID: 3e4dols9j52m0dpm4qm7x93
Creation Date: 3443472000 (seconds after year 1900)
Format: MS Word 2003 (.doc)
Computer Metadata - Structured
Metadata Types – All Together
Descriptive– Module 1 Information: Sponsor Name, Application
Date, Application Type
Structural:– Application Nbr., Sequence Nbr., Module, CTD Heading
Process:– Version Nbr., Status, Approved Date
Metadata Types – For eCTD
WonderDrugLabeling
Application Nbr: 998877
Sequence Nbr: 0010
Module: Admininstrative
CTD Heading: Labeling
Structural Metadata
Draft
Approved
Effective
Version: 2.0
Status: Approved
Approved Date: 12-FEB-2009
Process Metadata
M1.14Labeling
M1.14.1Draft Label
Module 5Efficacy
Module 4Safety
Module 3Quality
Module 2Summary
Module 1Admin
M1.14.2Final Label
Seq. Nbr0010
Application Nbr998877
Sponsor: MedImmune
Application Date: 23-MAR-2009
Application Type: IND
Descriptive Metadata
Metadata Types – For eCTD
Different Groups want to see documents differently– Submission Publishers
– Document Authors
– Clinical Trial Management
– Manufacturing
EDM Systems can allow for different Views– Views are based upon Metadata – ‘MetaViews’
MetaViews of Data
WonderDrugClinical Study
Sequence Nbr: 0010
Module: Efficacy (5)
CTD Maj-Heading: M5.3 – Clinical Study Reports
CTD Min-Heading: M5.3.5 Clinical Reports of Efficacy
CTD Heading: M5.3.5.1 – Controlled Clinical Studies
Structural Metadata – EDM & Publishing
M5.3.5Reports of
Efficacy M5.3.5.1Controlled
Clinical Studies
Module 5Efficacy
Module 4Safety
Module 3Quality
Module 2Summary
Module 1Admin
Seq. Nbr0010
M5.3Clinical Study
Reports
New
Operation: New
Version: 1.0
Process MetadataIndication: Influenza Virus
Descriptive Metadata – M5.3.5
MetaViews of Data – for eCTD
WonderDrugCover Letter
Indication: Influenza Virus
Descriptive Metadata
IND
Cover Letter
Regulatory
Quality
NonClinical
Administrative
Status: UnSigned
Version: 1.0
Process Metadata
WonderDrugClinical Study
Clinical
Product Vaccine
Study Nbr CS-1234
Clinical Study Body
Indication:Influenza Virus
Product: Vaccine Application Type: IND
Doc-Type: Regulatory Doc-Category: Cover Letter
Doc-sub-Type: Administrative
Structural Metadata
Product: Vaccine Study Nbr: CS-1234
Doc-Type: Clinical Doc-Category: Clinical Study Body
Indication: Influenza Virus
Structural Metadata
Signer: Dr. Reggy Affairs
Descriptive Metadata
Status: Signed
Version: 2.0
Process Metadata
MetaViews of Data – for Authors
Different EDM Systems use different Metadata - causing issues– External Authors
– Partners
– Mergers & Acquisitions
Consider 10,000’s Documents in EDM
MetaViews of Data – Issues
Indication: Influenza Virus
Descriptive MetadataWonderDrugClinical Study
Clinical
Product Vaccine
Study Nbr CS-V1234
Clinical Study Body
Indication:Influenza Virus
Therapeutic Area: VaccinesProduct: PRD-5432Doc-Type: Efficacy
Study Nbr: CS-V1234
Structural Metadata
Indication: Influenza Virus
Descriptive Metadata
Product: Vaccine Study Nbr: CS-1234
Doc-Type: Clinical Doc-Category: Clinical Study Body
Indication: Influenza Virus
Structural Metadata
Therapeutic Area:
Vaccines
Product PRD-5432
Efficacy
Study Nbr CS-V1234
WonderDrugClinical Study
MetaViews of Data – Partnerships
EDM Systems need Standard Views
EDM Systems need Metadata
EDM Reference Model– DIA EDM SIAC Reference Model Sub-Group
MetaViews of Data – Solution
Indication: Influenza Virus
Descriptive Metadata
WonderDrugClinical Study
Therapeutic Area: VaccinesProduct: PRD-5432Functional Area: ClinicalIndication: Influenza VirusStudy Nbr: CS-V1234Doc-Type: Clinical Study Body
Structural Metadata
Indication: Influenza Virus
Descriptive Metadata
Clinical
Study Nbr CS-V1234
Clinical Study Body
Indication:Influenza Virus
Therapeutic Area: Vaccines
Product PRD-5432
Product PRD-5432
Study Nbr CS-V1234
Clinical
Indication:Influenza Virus
Therapeutic Area: Vaccines
Clinical Study Body
MetaViews of Data – Partnerships
Summary
Human Metadata vs Computer Metadata
Metadata Types: Descriptive, Structural, Process
Views can vary based upon Metadata
Incommensurate Metadata can consume Money