an overview of cdisc a clinical data standards organization · clinical events (ce) death details...

© 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


Healthcare data, Repository Data, Research Data…

For what? Pool, compare, reanalyze, repurpose,

hypothesize, reinterpret, fish…


Funders

Regulatory Agencies

Publishers

Editorials

Nature 522, (10 june 2015)

The Public


Healthcare data, Repository Data, Research Data…

For what? Pool, compare, reanalyze, repurpose,

hypothesize, reinterpret, fish…


© 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


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


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


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


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


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


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


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


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


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


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


Data/Results

Study Protocol

Michael’s talk in Part 2


22


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


Data/Results

Study Protocol

CDISC Standards: Protocol

Protocol Representation Model (PRM)Machine-readable study design;

e.g., allows comparison of

outcomes across study designs


24


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


Data/Results

Study Protocol

CDISC Standards: Data Collection

FDASDTMHealthcare

Systems

Foundational Standards

CDASH

Example e/CRF


FDACDASH

ADaM

SDTM

PRM

Healthcare

Systems


CDASH

Example e/CRF

CDASH Specifications


FDACDASH

ADaM

SDTM

PRM

Healthcare

Systems


CDASH

Example e/CRF

Controlled Terminology (Code Lists)

CDASH Specifications


28


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


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




CDASH

ADaM

SDTM

PRM

Healthcare

Systems

SDTM

Controlled Terminology

SDTM Dataset Specifications





32


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


Data/Results

Study Protocol

CDASH

ADaM

SDTMHealthcare

Systems

ADaM

Analysis Dataset

CDISC Standards: Analysis Datasets

CDASH

ADaM

SDTMHealthcare

Systems

ADaMADaM Dataset Specifications

Analysis Dataset


CDASH

ADaM

SDTMHealthcare

Systems

ADaMADaM Dataset Specifications


Analysis Dataset



36


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


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


Programming (study

datasets/reporting)




Repositories

Electronic

Health

Records

(patient data)


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


• 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

http://www.cdisc.org/

http://www.cdisc.org/cdisc-user-networks

http://www.cdisc.org/forum

http://www.cancer.gov/cancertopics/terminologyresources/CDISC

http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm

http://www.fda.gov/medicaldevices/deviceregulationandguidance/datastandardsmedicaldevices/default.htm

http://www.linkedin.com/grps

http://www.phuse.eu/

http://www.magiworld.org/standards/

https://ncats.nih.gov/expertise/clinical

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

[email protected]

• For CDISC education inquiries, please contact

[email protected]

• 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]

mailto:[email protected]



http://www.cdisc.org/education-and-events

http://www.cdisc.org/membership



© 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

http://kestrelconsulting.trainingcampus.net/

an overview of cdisc a clinical data standards organization · clinical events (ce) death details...

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