CDISC 4 Pager Pages Web

7/24/2019 CDISC 4 Pager Pages Web

1/4

CDISC Vision & Mission

CDISC is a 501(c)(3) non-profit charitable organization, with ov

300 member organizations across the healthcare industry. O

organization and members are committed to maximizing the va

of medical and research information, to streamlining the resear

process and to accelerating the translation of research findings in

clinical decisions that benefit patients around the globe. CDI

has been made possible by the efforts and support of thousan

of dedicated volunteers, collaborating to realize the CDISC vis

and mission. CDISC global consensus-based standards for medi

research and its link with healthcare are vendor-neutral, platfor

independent and freely available via the CDISC website.

The CDISC Vision is to inform patient care and safety

through higher quality medical research.

The CDISC Mission is to develop and support global,

platform-independent data standards that enable

information system interoperability to improve

medical research and related areas of healthcare.

CDISC was initiated as a volunteer organization in 1997 and was

incorporated as a non-profit organization in February 2000. In

May of 2011, CDISC attained 501(c)(3) status, recognizing it as a

charitable organization. Since 1997, teams of volunteers have ensured

that efficient, consensus-based standards have been produced

through the CDISC Standards Development process. The standards

development process was updated in 2012 (using lessons learned

from the development of a number of therapeutic area standards)

to an improved, accelerated process that is now being implemented.

CDISC released its first production models in 2000 and has had

steady record of accomplishment ever since. In 2013, the U.S. Fo

and Drug Administration and the Japan Pharmaceuticals and Medi

Devices Agency released documentation announcing the intent

require data in CDISC format in the coming years. Additionally, t

European Medicines Agency, Korea Food and Drug Administrati

and China Food & Drug Administration are considering research

the use of CDISC standards.

Foundational Standards SemanticsData Exchange

THERAPEUTIC AREA STANDARDS & QUESTIONNAIRES

Achieving Interoperability

ODM/

SDM

XML

ODM

XML

Dataset

XML

Define

XML

Protocol

PRM

Study Design

HL7 RIM

Data Collection

CDASH

CDISC-Lab

HEALTHCARE

Patients Tabulation& Analyses

SENDSDTM

ADaM

Submission/PublicationReporting

SEND

SDTM

ADaM

CLINICAL & NON-CLINICAL RESEARCH

BRIDG

Controlled Terminology

Healthcare Link

Healthcare Link

CDISC SHARE


2/4

Modeling andNomenclature Groups> Glossary Group>ODM (DAS) and SDS

ADaM andLAB Teams

SEND Team Protocol RepresentationGroup ( CDISC-HL7)

Terminology Team;BRIDG Groups

100 MemberOrganizations

SDS v1.1

SDS v2.0; ODM v1.0;Glossary v1

(new versions annuallythereafter

ODM v1.1ADaM Models

Visits to Japanand Europe

ACRP and DIAprovided venues

DIA SIAC on Standards

DIA SIAC changed toeClinical SIAC

(DIA cannot establish

standards)

CDISC-HL7 CharterAgreement (CT-SIG);

renewal every 2 years

HL7 RCRIMreplaces CT-SIG

Collaborations

Globalization

CDISC Standards

and Innovations

Teams

The Organization Non-profit incorporation 501c6(32 Charter Members)

5-year Anniversary(~ 150 member orgs)

LAB v1.1;

ODM v1.2;SDTM v3.1

Courses inAustralia

Courses in Interchang

NCI-CDISC andIHE-CDISC

Collaboration begin

NIH Roadwith Duk

CV P

Define.xml tation Rele

SENDODM v1.2.1; ODM mappe

Volunteer GroupInitiated

SDS v1.0 andODM v0.8

LAB v1.0; SDTM v3.0;BRIDG Model Initiated

SEND 1.0; LAB V3Message passed ballot

E3C Initiated J3C Intiated

CDISC TImeline 1997-1999 2000 2001 2002 2003 2004 20

CDISC SHARE

Single, trusted, authoritative source for CDISC data standards

Concepts, metadata, collections, relationships, value sets across thefull spectrum of CDISC content

Supports change control, impact analysis and inheritance,transformation logic and governance workflows.

Aligned with NCI Semantic Systems Links research to healthcare concepts to support interoperability

Foundational Standards

Protocol Representation Model

BRIDG-based model and tools

for representing standard clinical

research protocol elements and

relationships.

CDASH

Clinical Data Acquisitions Standards

Harmonization is a specification

describing basic data collection

domains and variables for CRF data

with standard question text,

implementation guidelines, and

best practices.

LAB

Specification describing standard

content for the acquisition and

interchange of clinical laboratory

data between central labs and

sponsors or CROs.

ODM

Operational Data Model - XML

Schema specification for the

regulatory compliant acquisition,

exchange and archive of clinical

trials data and metadata.

Define-XML

XML Schema specification based

on ODM to describe metadata for

SDTM, SEND and ADaM submission

datasets.

Dataset-XML

XML Schema specification based

on ODM for representing study

datasets associated with Define-

XML metadata.

ADaM

Analysis Data Model describing fun-damental principles and standards

for representing analysis datasets

and metadata.

ADaM Time to Event Model

ADaM Adverse Event Model

SDTM

Study Data Tabulation Model

general model for representing

study tabulation data used in

clinical research.

SEND

Standard for Exchange ofNonclinical Data: SDTM IG

describing domains and variables

for data from nonclinical studies.

Semantics

Glossary

Glossary with definitions of

acronyms and terms commonly

used in clinical research.


A set of standard value lists,

developed and maintained in

The CDISC Standards and Implementations

partnership with NCI Enterprise

Vocabulary Services (EVS) to

support CDISC standards such as

SDTM, CDASH, ADaM from data

collection through submission.

BRIDG

Biomedical Research Integrated

Domain Group (BRIDG) UML mode

of the semantics of protocol-drive

clinical research.

BRIG, ISO21090

Protocol, CDASH

SDTM, ADaM

Terminologies

Facilities

Data

Exchange

Improvesaccess to datstandards

Traceability

Re-use ofconcepts

Acceleratesdevelopmenof standards

SHARE

CDISC SHARE

CDISC Metadata Repository sourcefor all CDISC standard metadata

and terminology.


3/4

Learn CDISC from CDISC!

The CDISC education program provides the

only courses for the CDISC standards that are

developed under the authority of a CDISC

Operating Procedure (COP-005). This ensuresthat the course materials are developed with

the cooperation of the CDISC technical teams

and delivered by instructors who are selected

through a rigorous set of qualification criteria.

Developed to advance the CDISC mission

and to ensure distribution of authoritative

educational courses across the medical

research continuum, CDISC authorized courses

are identified by the Education logo and are

only available through CDISC Education. Look

for the logo to be sure that you are receiving

authorized CDISC education.

EDUCATION

CDISC Authorized Education Courses:

1-day ADaM Implementation

1-day CDASH Implementation

-day Controlled Terminology

Implementation

1-day Deep Dive BRIDG Workshop

-day Introduction to BRIDG

1-day LAB Implementation

1-day ODM Implementation

-day Protocol Representation

2-day SDTM Theory and Application

2-day SDTM Theory and Application

for Medical Devices

1-day Healthcare Link

2-day SEND

ASH Team andeams; eSDI Group

Devices Team;SHARE Teams

Therapeutic AreaStandards projects

10-year anniversarysince incorporated,~ 250 member orgs

DM v1.3: LAB &

SDTM Aligned;CDISC-IHE RFD

BRIDG v1.0, v1.1; BRIDG

posted as open sourcemodel

BRIDG v2.0, v2.1, v2.2

CDASH v1.0; eSDIDocument Published

SDTM v3.1.2; ADam v2.1

Imaging CRFs CDISC-IHERFD and RPE

Networks initiatedrope (5 languages)

Courses in Brazil

Courses in China;RFD Training in Japan

South Africa initiatesUser Network

DISC-IHE Quality,search and PublicHealth (QRPH)

ISO Liason A StatusAwarded; ASTER

Launched

Critical PathInstitute/

CAMDAlzheimers;

TuftsPKD; ACCCVdisease

EMA cites CDISC eSDIrequirements; SHARPn

Project with ONC/Mayo; JIC Leadership;Rockefeller/FDA Painand Analgesics

HITSP: Use Case (EHRs forCore Research Data) Clinical Research Tiger TeamInitiated

Additional IHE Profiles Proposed(e.g. RPE); Greenway EHR-

Outcome Implementation of RFD

Courses inThailand and Singapore

CDASH v1.1; SEND v3.0;Study Design XML v1.0;

C-Path MOU Signed;Gates Foundation-TB

K3C Initiated

CDISC accepted into JointInitiative Council (JIC) forGlobal Harmonization of

Healthcare Standards

Protocol RepresentationModel (PRM) v1.0; BRIDG v3.0;

ODM v1.3.1; HHS-ONC/HITSPInteroperability Specification

#158; CDISC-IHE RPE

C3C Initiated

501c3 status (charitable)approved by US IRS;

CDISC Europe Foundationlaunched

Alzheimers DiseaseTA Package

2006 2007 2008 2009 2010 2011 2012 2013

300 Member MarkAchieved; Austin OfficeEstablished; CFAST TA

Program SteeringCommittee Established

CFAST Scientific AdvisCommittee Establishe

>320 Members;CFAST Grant Awarded by

CDISC Grows to >20Employees

CFAST TA StandardsTeams

Essential Standards to EnLearning (ESTEL) Initia

Launched;7 New CFAST TA Team

Initiated

Global Regulatory AuthoAnnounce Intent to Req

CDISC Standards in NeFuture;

First CDISC Asia-Pacific Inchange Held in SingapoAsia-Pacific CDISC Coornating Committee (AP

Established;CDISC User Groups star

in India

IMI, NCI EVS & C-PatRelationships StrengtheLearning Health Comm

MOU

Updates to Foundational Standards; Updates to X

Data Exchange Standards; Updates to SemanticUpdates to Implementations

10th Anniversary for CDISC Japan ; CDISCWorkshops with AmCham in China; WHO

Forum on Health Data Standardizationand Interoperability; EMA Workshop onClinical-trial Data and Transparency; Eu-

ropean Commission Projects ConvergenceRound Table

Endorsed core valuesof the Learning Health

System;CDISC engaged in 3 IMI

Consortia projects; NIH/FDA Grants; Leading role

in JIC;One Mind for Research

Workshop

TRI (Japan) MOU SignedIMI (Europe) MOU

Signed

Therapeutic Area Standards

The goal of the development of CDISC Therapeutic Area (TA) standards,

under the CFAST initiative, is to identify a core set of clinical therapeutic

area concepts and endpoints for targeted therapeutic areas and translate

them into CDISC standards to improve semantic understanding, suppor t

data sharing and facilitate global regulatory submission. A list of available

TA standards is below:

Alzheimers Disease Asthma

Pain Questionnaires

Parkinsons Disease

Polycystic Kidney Disease

Tuberculosis

Healthcare Link Standards

The CDISC Healthcare Link Initiative has developed a suite of CDI

inspired IHE standards and enablers to improve the workflow of clinicia

doing research, leveraging electronic health records and resea

systems.

Retrieve Form for Data Capture(RFD)

Clinical Research Document (CRD)

Drug Satety Content (DSC)Redaction Services

Retrieve Process Execution (RPE)

Clinical research Process Content (CRPC)

Research Matching

Data Element Exchange (DEX)

In Development for 2014:

DataSet-XML

Pharmacogenomics

Online Courses:

SDTM

CDASH

ADaM


BRIDG

Therapeutic Areas


4/4

Gold Member Benefits

1. NEW! Webinars for Members ONLY starting in 2014

2. NEW! Opportunity to be CDISC ODM certified

3. Access to Members Only area on the CDISC website for every

employee of member organization

4. 20% discount for CDISC Education Courses and CDISC Events

5. Opportunity to be a CDISC Registered Solution Provider

6. Opportunity to participate in CDISCs licensed training progra

7. Personalized Gold Member plaque

Platinum Member Benefits

All the Gold Member Benefits PLUS the following:

1. NEW! Platinum members will have free access to CDISC SHARE

content in 2014

2. Representation on the CDISC Advisory Council (CAC), with the

following benefits:

Networking opportunities and face-to-face meetings with p

clients and visionaries

Opportunity for representation on Board Committees (StratTechnical and Financial)

Opportunity to vote a Board Member onto the CDISC Board

Directors

Opportunity to participate in Town Hall meetings with regu

and CDISC Board members

3. Additional 20% Discount (i.e. 40% total) for CDISC Education C

and CDISC Events

4. CDISC Overview course CDISC Global Approach to Acceleratin

Medical Research can be given at Member site upon request

5. Personalized Platinum Member plaque

MEMBERS BY INDUSTRY

Technology Service

Provider: 33%

Pharmaceutical: 19%

Other: 3%

Healthcare Provider: 2%

Government: 2%

Consulting: 6%

Academic Institution: 1%BioTech: 5%

CRO: 26%

NPO: 3%

Medical Device 25,000 $ 29,000 $ 35,000 Annual fee+$35,000

Academic Institution For rates, please contact

Government CDISC Membership at

Non-profit Organization [email protected]

Discounts to CDISC Education and Events: 20% for Gold and

40% for Platinum

For membership upgrades, contact CDISC Membership at

[email protected]

Learn more about CDISC

at www.cdisc.org

Documents

CDISC 4 Pager Pages Web