What We Need to Know About CDISC
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The document discusses CDISC standards and their implementation. It begins by asking what the CDISC standards are, when is the best time to implement them, and the timeline for requiring them in FDA submissions. It then explains that CDISC develops data standards for medical research through an open consensus process. Implementing standards early in a clinical program saves time and money compared to converting legacy data later. The FDA will require CDISC standards like SDTM and ADaM for submissions through binding guidance issued in 2012 as part of critical path initiatives and legislative acts. Resources are available to stay up to date on standards development.
What We Need to Know About CDISC
- 1. What we need to know about CDISC Shannon Labout, CCDM Director, Data Management
- 2. WHAT WE NEED TO KNOW ABOUT CDISC What are the CDISC standards? What is the best timing to implement CDISC standards in a clinical program? What is the timeline for requiring CDISC Standards in FDA Submissions?
- 3. WHAT ARE THE CDISC STANDARDS CDISC organized as a non-profit standards developing organization (SDO) in 2000 CDISC works closely with other SDOs (e.g., HL7, ISO) and with the FDA CDISC develops standards for medical research (started with volunteers in 1990s) CDISC standards development is an open, consensus-based process, powered by volunteers www.CDISC.org
- 5. TIMING OF IMPLEMENTATION MATTERS! 1. If you choose to convert your legacy data to SDTM at the end of the process Allows you to hold on to your old processes and standards But… Adds significant time, effort, and expense at the end of the process Legacy data conversion can introduce other significant problems
- 6. LEGACY DATA CONVERSION PROBLEMS No 1:1 relationship between CRF and SDTM domains/variables means you will have to spend a lot of time mapping data to the right domains/variables Collected values may not map to controlled terminologies that are required No standards definitions/assumptions make the data less “combinable” – may not be able to map with the same meaning
- 7. TIMING OF IMPLEMENTATION MATTERS! 2. Streamline your processes by building (industry) standards into your process up-front: Saves time, money, effort Automatically generate deliverables throughout Build a standard library of CRFs, database structures, SAS programming, etc. Reduce (or eliminates) mapping and re-programming throughout the process Makes data more combinable, re-usable Allows data sharing with vendors and other research partners more easily Supports FDA objectives Standard format for data submissions and data repository Builds in transparency and traceability
- 8. IMPLEMENT STANDARDS FROM THE START ODM – designed to hold CDISC content plus audit trail, based on XML PRM – structured protocol information makes it reusable downstream (registries, EDC, CSR, labeling), based on XML CDASH – standard metadata for CRFs is harmonized with other CDISC standards – makes it easier to get to SDTM and ADaM Controlled terminologies with standard definitions Everyone collecting the same information the same way makes that data more usable and meaningful in a data repository
- 9. WILL CDISC STANDARDS BE REQUIRED? Two Perspectives
- 10. YES! CDISC STANDARDS WILL BE REQUIRED Supporting the Vision, Innovation and Opportunity of the Critical Path Initiative
- 11. YES!! CDISC STANDARDS WILL BE REQUIRED
- 12. Whichever way we choose to look at it… CDISC STANDARDS ARE NO LONGER OPTIONAL FOR FDA SUBMISSIONS
- 15. CRITICAL PATH INITIATIVE The Critical Path Initiative (CPI) is FDA's national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured. FDA was hoping that industry would voluntarily adopt standards…
- 16. 2004 Critical 2006 Federal Path Register Initiative Notice
- 17. FEDERAL REGISTER NOTICE In 2006, FDA told us the requirement was coming all submissions to be electronic all submissions to follow standard formats (e.g., SDTM) They were still hoping we would voluntarily adopt standards…
- 18. 2004 2006 2008 2010 Critical Federal Federal Federal Path Register Register Register Initiative Notice Notice Notice
- 19. WHAT’S HAPPENED SINCE THEN? ARRA $$ invested in FDA’s standards implementation CDER Computational Science Center Cross-Center FDA Data Standards Council New Software and Tools New Review Environment Janus V1, V2, V3 CDISC training developed for FDA reviewers CDISC Standards are being built in at FDA
- 20. FDASIA INTRODUCES THE REQUIREMENT 2012 FDASIA and PDUFA V
- 21. FDASIA Food and Drug Administration Safety and Innovation Act of 2012 Signed into law July 2012 Became effective October 2012 a few key points Reauthorizes PDUFA and MDUFA Creates User Fees for Biosimilars and Generics Section 1136 requires electronic submissions in a standard format to be referenced in binding Guidance
- 22. PDUFA V IT PLAN Objective “FDA is committed to achieve the long-term goal of improving the exchange, review, and management of human drug and biologic applications throughout the product life cycle through strategic investments in automated, standards-based information technology (IT).”
- 23. BINDING GUIDANCE FDA will issue final guidance no later than 12 months from the close of the public comment period on the draft guidance. Such final guidance and any subsequent revisions to the final guidance shall be binding on sponsors, applicants, and manufacturers no earlier than twenty-four months after issuance of the final guidance.
- 24. DRAFT GUIDANCE ISSUED 2012 Harmonized cross-center CDER – Drug applications CBER – Biologics applications CDRH – Device / Radiological applications Specifies the requirement for electronic submission in a standard format FDA publishes the standard formats they will accept on their data standards web page References these CDISC standards SDTM - tabulations of collected data Controlled Terminology – allowed values ADaM – analysis datasets (supports CSR) SEND – pre-clinical data (based on SDTM) Define.xml – standard metadata format http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm
- 25. FREE WEBINAR “CDISC WILL BE REQUIRED!” AVAILABLE ONLINE AT HTTP://KESTRELCONSULTING.TRAININGCAMPUS.NET
- 26. DEVELOPING TA STANDARDS FDA has published intent to help industry create therapeutic area (TA) specific standards by 2017 (PDUFA V commitment letter) High priority therapeutic areas published on FDA website (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Form sSubmissionRequirements/ElectronicSubmissions/ucm287408.h tm#_ftnref10) Working with CDISC and others to develop TA Standards development open to all who can participate (http://www.cdisc.org/therapeutic)
- 27. FDA Timeline This assumes standardization projects for therapeutic areas would be scoped narrowly enough to be accomplishable within a 12-month period, and that subsequent projects in those areas would build on the results.
- 28. CDISC Timeline
- 29. HOW WE CAN STAY UP TO DATE Monthly CDISC webinars Updates on what’s being released for public review – new domains, new terminology, etc Free to attend live webinar Archives are available on demand to CDISC members CDISC Newsletter (monthly, free) CDISC website (www.cdisc.org) CDISC Education & Events Private and public courses Conferences (Interchange) in US, EU and AP
- 30. RESOURCES www.cdisc.org/foundational-standards - Starting point for all the standards http://www.cdisc.org/content6283 - Technical development plan (Gantt chart) http://www.fda.gov/ForIndustry/DataStandards/ StudyDataStandards/default.htm Email accounts for questions (cber.cdisc@fda.hhs.gov, cder-edata@fda.hhs.gov, cdrh.cdisc@fda.hhs.gov) http://www.opencdisc.org/ Validation of your submission Help with Define.xml
- 31. TAKE AWAY MESSAGES It’s time to implement CDISC standards - no longer optional for FDA submissions Right now – FDA wants SDTM/ADaM In the near future – FDA will require SDTM/ADaM Update / improve your processes to take full advantage of these industry standards Get involved with standards development Contribute your TA-specific knowledge Help develop the standards we all will have to use
- 32. THANK YOU! Shannon Labout, CCDM Director, Data Management slabout@sdcclinical.com