1. What’s New with CDISC
Wayne R. Kubick CDISC CTO

2. 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

3. The CDISC Mission Wayne’s 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

4. 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

5. 2014 Technical Plan – Q3 Update
Changes to Roadmap include adjustment of timelines, new Vaccine Data IG project, new CT Registry project, multiple SHARE projects, removal of healthcare link.

6. 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)

7. Governing the SDTM Product Family
Bridging the Silos:
Governing the SDTM Product Family
Study Data Tabulation Model (SDTM)
SDTMIG
Human Clinical
SDTMIG-MD
Medical Devices
SEND IG
Non-Clinical
SDTMIG-PGx
Pharmacogenomics
SDTMIG-AP
Associated Persons
CDISC Therapeutic Area User Guides
SDTMIG QS
Supplements

9. It’s about Patients, People!
CFAST and Therapeutic-Area Data Standards:
It’s about Patients, People!

10. Asthma User Guide Example

11. Current CFAST Working Plan

12. CDISC Technical Roadmap - 2014
Foundational Standards
Data Exchange Layer
XML, RDF, …
PROTOCOL
SDS/SDTM Products
CDASH
Semantic Layer
BRIDG/Terminologies/SHARE
SEND
ADAM
Functional Layer
SDTM, SEND, ADaM, CDASH …
Others
XML Technologies
Semantics
Implementation Layer
Therapeutic Area Guides,
Questionnaire Guides
Healthcare Interoperability Kits
Controlled Terminology
BRIDG
CDISC SHARE R R R3
Therapeutic Areas (CFAST)
Track 1 Projects
Changes to the Roadmap include an initial timeline orientation (with Release of SHARE R1), removal of Glossary (not active, and no transition planned to SHARE), and removal of separate Healthcare Interoperability tracks.
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

13. What is SHARE?
SHARE is a standards metadata repository for authoring, governing, and publishing CDISC standards
SHARE combines
SOA Semantics Manager
ISO 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 13

14. User Perspectives of SHARE
iSHARE
(SHARE Interactive)
eSHARE
(SHARE Exports)
Standards Development
& Governance
Accessing Published Standards
in a Machine-Readable Format

15. The CDISC Standards Process

17. Opportunities for Participation in CDISC and CFAST Projects
Read and provide comments on CDISC standards posted for review
Volunteer for CDISC teams at any time through the CDISC Website
Respond to a CFAST call for participation for specific roles on named projects (e.g., Clinical SME for Dyslipidemia, Medical Writer Diabetic Nephrology)
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)
Participate in the future collective management of CDISC standards as part of a proposed new CDISC SHARE Metadata Curation Collaboration initiative
Planned for details to be discussed separately later.