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CDISC
CDISC defines standards to be used or reused in the definition, development, and execution of clinical trials as well as the submission of the clinical trial data to regulatory agencies (e.g., FDA) for drug, device or procedure approval. CDISC is currently focused on constructing a Shared Health and Research Electronic Library (SHARE) and would like to use the NCI Knowledge Repository as the basis for SHARE.
CDISC SHARE will contain the existing CDISC standards and will provide machine readable element (variables) within those standards. This will allow a range of applications used within other organizations (e.g., Clinical Research Organizations _(_CROs), Pharma, and other Agencies) to automatically access those definitions.
1. CDISC-1: CDISC wants a Distributed, Collaborative Environment and a Distributed Knowledge Repository to capture and manage its Metadata.
2. CDISC-2: There is a need for High-Quality Governance, Data Element Definitions Input, and Normalization in authoring CDISC standards.
3. CDISC-3: Support the Harmonization of External Data Standards.
4. CDISC-4: Develop Tooling to Shorten the Time it Takes to Collaboratively Define CDISC Standards.
5. CDISC-5: Normalize & Harmonize Data Element Definitions via Group Collaboration.
6. CDISC-6: Normalization & Harmonization requires better Visualization & Browsing/Search tools.
7. CDISC-7: Use the Metadata Model being Developed by CDISC SHARE Team 2
8. CDISC-8: The CDISC SHARE meta-model should incorporate BRIDG (Biomedical Research Integrated Domain Group) Domain Analysis Model (DAM).
9. CDISC-9: Use Controlled Terminologies and Harmonize them across the Research and Healthcare domains.
10. CDISC-10: Use Ontologies to Help Create High Quality Data Element Definitions.
11. CDISC-11: Create Templates as CDISC SHARE Reusable Entities.
12. CDISC-12: CDISC Standards Should Support both existing Tabular Formats and Other Emerging Formats.
13. CDISC-13: The Knowledge Repository Should Delivery CDISC Standards/Content to the CDISC Membership and manage its Metadata.
14. CDISC-14: CDISC Metadata should be Machine-Interpretable as well as Available to authorized Humans.
15. CDISC-15: CDISC Is Interested in Generating Standards-Based Forms.
16. CDISC-16: KR Versioning/Change Management and Traceability.
17. CDISC-17: Support Global Use of Biomedical Research and Healthcare data.
18. CDISC-18: Use CDISC Standards to Enable the Query/Aggregate Data (e.g., Computer and Healthcare Classes. (e.g. CDISC-19 clinical trials and health records integration) is a critical CDISC Requirement.
19. CDISC-19. Use CDISC standards to integrate Clinical Trial Data with Health Record Data.
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