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

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

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

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

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.

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)

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

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

Asthma User Guide Example

Current CFAST Working Plan

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 R1 R2 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

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 13

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

The CDISC Standards Process

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 2015 -- details to be discussed separately later.