© CDISC 2016
An Overview of CDISC:
A Clinical Data Standards Organization
Kit Howard, MS, CCDM, CRCP
CDISC, Director of Education
Co-Leader Medical Device Standards Development
Michael Ibara
CDISC, Head of Digital Healthcare
MDEpiNet Webinar, 17-Jun-2016
© CDISC 2016
Agenda
• Part 1 - Kit
Introduce CDISC and its clinical standards
Where do CDISC standards fit into the larger
picture of standards
Opportunities to leverage CDISC in MDEpiNet
projects
• Part 2 - Michael
Describe CDISC’s eSource initiative
Introduce topic area challenges and
opportunities
© CDISC 2016
What is CDISC?
Clinical Data Interchange Standards Consortium
Non-profit Global Standards Development Organization (SDO) based in Austin, TX
Founded in 1997, incorporated in 2000; over 400 member organizations
Develops open and free data standards for clinical research
Funders
Regulatory Agencies
Publishers
Editorials
Nature 522, (10 june 2015)
The Public
Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC)
Pressure to Share Data is Intense:
Funders
Regulatory Agencies
Publishers
Editorials
Nature 522, (10 june 2015)
The Public
Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC)
Healthcare data, Repository Data, Research Data…
For what? Pool, compare, reanalyze, repurpose,
hypothesize, reinterpret, fish…
Pressure to Share Data is Intense:
Funders
Regulatory Agencies
Publishers
Editorials
Nature 522, (10 june 2015)
The Public
Slide courtesy of Philippe Rocca-Serra (U of Oxford) and Paul Houston (CDISC)
Healthcare data, Repository Data, Research Data…
For what? Pool, compare, reanalyze, repurpose,
hypothesize, reinterpret, fish…
Pressure to Share Data is Intense:
© CDISC 2016
What do we want to do?
Want to save lives, improve quality of life
Must be able to share data to, e.g., replicate results, access larger pools of data…
BUT… it’s useless if the data aren’t fit for intended uses
Clinical research data standards are part of solution
© CDISC 2016
CDISC Can Help…
• Core clinical data
• Therapeutic area data
• Device data including
• Pre-market UDI analogue
• Design to capture “in-use” settings
Defined data structures optimized for research and designed for pooling
Also supports data repository structures to pool repositories and pool with clinical research data
Understands HL-7 via ISO-approved BRIDG
Streamlines FDA submission production
Part of determining if data are comparable
© CDISC 2016
What is a Clinical Research Data Standard?
A set of defined data elements, their characteristics and relationships among them
Rules for creating, managing and using the data elements
A design for combining data meaningfully when they have been collected in many different places and ways
A best practice for managing data
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
CDISC in the World of Standards
10
HL-7
MDEpiNet
JICONC
MDIC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
Organizations of Standards Orgs
11
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
12
Government/Regulatory
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
13
Healthcare & Public Health
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
14
Healthcare Informatics
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
15
Dictionaries/ Terminologies
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
16
Foundations & non-profits
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
17
Operational Standards
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
18
Watchdogs
MDIC
HL-7
MDEpiNet
JICONC
HITSP
FDA
ICH
WHONIH
ANSI
CEN
CDISC
MSSO
EMA
MHLW
IHTSDOMedical
Orgs
ISO Reagan-UdallCTTI
MCC
TransCelerate
NCVHS
PHIN
UMLS
NLM
CONSORT
C-Path
CDISC in the World of Standards
19
HL-7
MDEpiNet
JICONC
MDIC
HITSP
Typical Data Flow in Clinical Research
20
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
CDISC’s Foundational Standards Can Help
21
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
Michael’s talk in Part 2
CDISC’s Foundational Standards Can Help
22
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
CDISC Standards: Protocol
Protocol Representation Model (PRM)Machine-readable study design;
e.g., allows comparison of
outcomes across study designs
CDISC’s Foundational Standards Can Help
24
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
CDISC Standards: Data Collection
FDASDTMHealthcare
Systems
Foundational Standards
CDASH
Example e/CRF
CDISC Standards: Data Collection
FDACDASH
ADaM
SDTM
PRM
Healthcare
Systems
Foundational Standards
CDASH
Example e/CRF
CDASH Specifications
CDISC Standards: Data Collection
FDACDASH
ADaM
SDTM
PRM
Healthcare
Systems
Foundational Standards
CDASH
Example e/CRF
Controlled Terminology (Code Lists)
CDASH Specifications
CDISC’s Foundational Standards Can Help
28
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
CDASHSDTM
Healthcare
Systems
SDTM
Example Reporting Data
CDISC Standards: Study Datasets/ Reporting
Data Comes from CDASH
CDASH
ADaM
SDTM
PRM
Healthcare
Systems
SDTMSDTM Dataset Specifications
Example Reporting Data
CDISC Standards: Study Datasets/ Reporting
Data Comes from CDASH
CDASH
ADaM
SDTM
PRM
Healthcare
Systems
SDTM
Controlled Terminology
SDTM Dataset Specifications
Example Reporting Data
CDISC Standards: Study Datasets/ Reporting
Data Comes from CDASH
CDISC’s Foundational Standards Can Help
32
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
CDASH
ADaM
SDTMHealthcare
Systems
ADaM
Analysis Dataset
CDISC Standards: Analysis Datasets
CDASH
ADaM
SDTMHealthcare
Systems
ADaMADaM Dataset Specifications
Analysis Dataset
CDISC Standards: Analysis Datasets
CDASH
ADaM
SDTMHealthcare
Systems
ADaMADaM Dataset Specifications
Controlled Terminology
Analysis Dataset
CDISC Standards: Analysis Datasets
CDISC’s Foundational Standards Can Help
36
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol
Data are the SAME
when...
Ask the Same
Question
Use the Same
Answer Set
Use the Same Name
Save in the Same
Structure
How do we know if data are the same?
Use Same Assumptions
Assuming you ask a valid question…
© CDISC 2016
Foundational (Core) Standards Cover
Interventions Events Findings Special Purpose
Concomitant
Medications (CM)
Adverse Events
(AE)
ECG (EG) Demographics (DM)
Exposure (EX) &
Exposure as
Collected (EC)
Medical History
(MH)
Inclusion Exclusion
Criteria (IE)
Comments (CO)
Procedures (PR) Disposition (DS) Lab (LB) Subject Visits (SV)
Substance Use (SU) Device Events (DE) Questionnaires
(QS)
Subject Elements
(SE)
Device Exposure
(DX)
Healthcare
Encounters (HO)
Subject
Characteristics (SC)
Device Subject
Relationship (DR)
Clinical Events (CE) Death Details (DD)
Device Tracking
(DT)
Vital Signs (VS)
Foundational Standards Implementations
39
Study Data Collection
Programming (study
datasets/reporting)
Statistics(analysis datasets)
Clinical Study Reports
FDA (submissions)Publications
Repositories
Electronic
Health
Records
(patient data)
Patient Care World Clinical Research World
Data/Results
Study Protocol• (General) Human Clinical Trials Implementation
Guide (IG)
• Device IG
• Therapeutic Area User Guides (UG)
• Major Depressive Disorder
• Alzheimer
• Diabetes
• Cardiovascular Endpoints
• Etc.
• PGx IG
• Associated Persons IG
• Animal Toxicology/Reproductive Toxicology IG
Devices IG
© CDISC 2016
Seven Device Domains
Special Purpose Domains
Device Identifi
ers (DI)
Consistent unique
sponsor-defined
identifier that links data
across domains.
Device-Subject
Relationship (DR)
Look-up table
providing single
consistent link between each device and subject
Findings
Device Propert
ies (DO)
Important unvarying
device characteristics that are not
identifiers
Device-In-Use
(DU)
Measurements and
settings intentionally set that may
vary between uses of a
device
Interventions
Device Expos
ure (DX)
Subject’s exposure to a medical
device under study
Events
Device Events (DE)
Reportable device-related
occurrences such as
malfunctions and
calibrations
Tracking and
Disposition (DT)
Physical locations of
device, either at
each movement or
just finalstatus
Devices Covered in Device IG
Device Not
Under Study
Device Under
Study
Class II & III
requiring submission
Single vs Multiple
Component
Subject:Device
1:1
1:Many
Many:1
Many:Many
Drug/Device
Combos
Diagnostics
Implantables
Software
Reagents
Dialysis
Machines
Powered
Wheelchair
Denture
Adhesive
Injectables
© CDISC 2016
CDISC Therapy Area Standards Using Device DomainsN
atio
nal In
stitu
tes o
f
Health/D
epart
ment
of
Health
and H
um
an S
erv
ices
Asthma
Image:
CS
F
Alzheimer’s
Traumatic Brain Injury
DiabetesInfluenza
QT Cardiac
© CDISC 2016
CDISC Can Help…
• Core clinical data
• Therapeutic area data
• Device data including
• Pre-market UDI analogue
• Design to capture “in-use” settings
Defined data structures optimized for research and designed for pooling
Also supports data repository structures to pool repositories and pool with clinical research data
Understands HL-7 via ISO-approved BRIDG
Streamlines FDA submission production
Part of determining if data are comparable
© CDISC 2016
CDISC Not Specifically Designed for…
EHR Data
Inventory management
Cost data
…
Can interface and store clinical trials-related data
Informing patient care and
safety through higher quality
medical research
Thank you!
© CDISC 2016
Supplementary Materials
© CDISC 2016
CDISC Standards (1)
• Clinical Data Acquisition Standards Harmonization model
• Used to design data capture structures consistently
CDASH model
• Implementation Guide for implementing CDASH model for core and custom domains
• Codifies rules for capturing CDISC-conformant data
CDASH IG
• Study Data Tabulation Model
• Used to guide development of clinical and other study data structures
SDTM model
• Study Data Tabulation Model Implementation Guide
• Structure and content of subject and study design data in electronic files
SDTM IG
• Analysis Data Model, Implementation Guide
• Structure of analysis datasets
ADaM & ADaMIG
© CDISC 2016
CDISC Standards (2)
• Operational Data Model
• XML model for describing, transmitting & managing CRF-based data
ODM
• Laboratory
• Content standard for defining lab dataLAB
• Defines code lists/controlled terms for CDISC variables
• NCI’s Enterprise Vocabulary Enterprises provides controlled versioned management
Controlled Terminology
• CDASH, SDTM & Controlled Terminology done together
• Initial focus: Implantable & similar devicesDevices
• Biomedical Research Integrated Domain Group Model
• Framework for clearly defining data elements and for linking and harmonizing to other standards
BRIDG
© CDISC 2016
CDISC Standards (3)
• Shared Health and Research Electronic Library
• Central electronic repository for CDISC standards
• In developmentSHARE
• Protocol Representation Model
• Structured way of describing protocol elements that allows them to be search on, e.g., eligibility criteria
PRM
• Standard for the Exchange of Non-clinical Data
• Pre-clinical data exchange definitions, currently animal toxicology and reproductive toxicology
SEND
• Gateway/system for moving data between EHRs and EDC
• Based on required CCD output from all EHRsHealthcare Link
• Alzheimer’s, Polycystic Kidney Disease, TB, selected biomarkers, et al
Therapeutic area standards
© CDISC 2016
Standards-Related Resources
• CDISC website http://www.CDISC.org
Information about CDISC, the standards, education/training, membership,
sponsorship, meetings/events, and more
• CDISC User Networks www.cdisc.org/cdisc-user-networks
• CDISC Discussion Forum www.cdisc.org/forum
• EVS Controlled Terminology
http://www.cancer.gov/cancertopics/terminologyresources/CDISC
• FDA Data Standards
Applies mostly to CDER & CBER
http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
CDRH standards page
http://www.fda.gov/medicaldevices/deviceregulationandguidance/datastandards
medicaldevices/default.htm
• LinkedIn CDISC Groups www.linkedin.com/grps
• PhUSE www.phuse.eu
• MAGI: http://www.magiworld.org/standards/
• NIH: https://ncats.nih.gov/expertise/clinical
CDISC Education: Classroom
• Include major standards, e.g., CDASH, SDTM, ADaM
• Regularly scheduled public events in major cities globally
• Private training can be requested at any time
Public
Licensed
Private
CDISC Education: Online
• Most major standards
• Therapeutic area standards
• 30-minute modules grouped into courses
• Videos, voice over slides, exercises
On Demand Courses
• 60-90 minute members-only webinars
• Recorded and available on members site
• Deeper dive into focused topics
• Video, voice over slides, recorded Q&A
Mini-Training Webinars
• 60-90 minute webinars later available online
• Focus on recently released draft and final standards
• Video, voice over slides, recorded Q&A
Public Webinars
• Selected free modules available at http://cdisc.trainingcampus.netFree modules
© CDISC 2016
CDISC Contact Information
and Helpful Links
• For CDISC membership inquiries, please contact
• For CDISC education inquiries, please contact
• For general CDISC inquiries, please contact [email protected]
• Click here for more info on CDISC Education
• Click here for more info on CDISC Membership
• For help on handling FDA data issues: [email protected]
• For help with FDA submission issues: [email protected]
© CDISC 2016
For More on the World of Standards…
Please visit http://kestrelconsulting.trainingcampus.net, create an account, click Product Catalog, C-11 Free Courses from Kestrel, Kestrel-014a-Overview of Standards 2013
Webinar includes definitions of the acronyms in the slides, and explanations of the organizations’ functions
The World of Standards webinar was created by Kit Howard when she was a consultant at Kestrel. It is not endorsed by CDISC. Kit is not currently accepting consulting engagements