1. No category

What’s New with CDISC
Wayne R. Kubick
CDISC CTO
© CDISC 2014
1
Agenda:
Things Old, Things New
and Things to Come
•
•
•
•
•
•
CDISC Standards and Me
Foundational Standards
Therapeutic Area Standards
SHARE Metadata
Tools and Processes
CDISC Standards and You
© CDISC 2014
2
The CDISC Mission
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.
Wayne’s Mission
Data Standards to Improve Clinical Research
© CDISC 2014
3
What is a CDISC Data Standard?
A CDISC data standard is any product (including
specifications, user guides, implementation guides,
models or schemas) provided by CDISC that
describes representation of clinical* research data
and has been properly developed, vetted and
approved through the CDISC process.
* And non-clinical
© CDISC 2014
4
2014 Technical Plan – Q3 Update
© CDISC 2014
5
Progress Update – Foundational Stds
Products Released in 2014:
• Dataset-XML v1 Final
• SDTMIG 3.3 Batch 1 (4 draft domains)
• ADaM Occurrence Data Structure v1 Draft
• ADaM IG v1.1 Draft
• Quarterly Terminology and Periodic QS
Supplements
• Updated COP-001 and Process Docs
• ADaM Results Metadata Specification
Upcoming New Drafts for Comment:
• Pharmacogenomics IG v1 Draft
• SEND v3.1 Draft
• SDTM Batch 2 (Disease Milestones, Domains)
© CDISC 2014
6
Bridging the Silos:
Governing the SDTM Product Family
SDTMIG-PGx
Pharmacogenomics
SEND IG
Non-Clinical
SDTMIG QS
Supplements
SDTMIG
Human Clinical
SDTMIG-AP
Associated Persons
SDTMIG-MD
Medical Devices
Study Data Tabulation Model (SDTM)
© CDISC 2014
7
© CDISC 2014
8
CFAST and Therapeutic-Area Data Standards:
It’s about Patients, People!
© CDISC 2014
9
Asthma User Guide Example
10
© CDISC 2014
Current CFAST Working Plan
© CDISC 2014
11
CDISC Technical Roadmap - 2014
Foundational Standards
Data Exchange Layer
PROTOCOL
XML, RDF, …
SDS/SDTM Products
CDASH
Semantic Layer
SEND
BRIDG/Terminologies/SHARE
ADAM
Functional Layer
Others
SDTM, SEND, ADaM, CDASH …
XML Technologies
Semantics
Implementation Layer
Controlled Terminology
Therapeutic Area Guides,
Questionnaire Guides
Healthcare Interoperability
Kits
BRIDG
CDISC SHARE
R1
R2
R3
Therapeutic Areas (CFAST)
Track 1 Projects
Track 2 Projects
Track 3 Projects
Health Care Interoperability
The Roadmap depicts evolution from siloed standards to an integrated stack based on BRIDG and SHARE
© CDISC 2014
12
What is SHARE?
• SHARE is a standards metadata repository for authoring,
governing, and publishing CDISC standards
• SHARE combines






SOA Semantics Manager
ISO 11179 Metadata Model
CDISC Standards Model
CDISC Foundational and TA Standards
Controlled Terminology
Exports to ODM, Define-XML and RDF
• Enables the development of a consistent, end-to-end
standards model
© CDISC 2014
13
13
User Perspectives of SHARE
SHARE
iSHARE
eSHARE
(SHARE Interactive)
(SHARE Exports)
Standards Development
& Governance
© CDISC 2014
Accessing Published Standards
in a Machine-Readable Format
14
The CDISC Standards Process
© CDISC 2014
15
© CDISC 2014
16
Opportunities for Participation in
CDISC and CFAST Projects
1. Read and provide comments on CDISC standards posted for
review
2. Volunteer for CDISC teams at any time through the CDISC
Website
3. Respond to a CFAST call for participation for specific roles on
named projects (e.g., Clinical SME for Dyslipidemia, Medical Writer
Diabetic Nephrology)
4. Seek management approval to apply for a position in the proposed
new CDISC Fellows Program – discussed in this presentation
 This will both maintain continuity between CFAST projects as well as
build expertise in sponsoring organizations (Industry, CROs, Vendors)
5. Participate in the future collective management of CDISC
standards as part of a proposed new CDISC SHARE Metadata
Curation Collaboration initiative
 Planned for 2015 -- details to be discussed separately later.
© CDISC 2014
17
© CDISC 2014
18