CDISC mission statement from CDISC website says "CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata. 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. CDISC standards are vendor-neutral, platform-independent and freely available via the CDISC website."
We will cover each CDISC standard in detail in the coming posts, here is a summary table with links to the current standard specification at http://www.cdisc.org. To give an overview the different parts of the CDISC standard are related as below to the clinical trial process
CDISC Standards in Production
| Submission Data Standards Team (For submission of data-sets to regulatory) | (SDTM IG V3.1.1) |
| Operational Data Modeling Team | (ODM V1.3) See also (eSDI Document) |
| Analysis Dataset Model Team | (ADaM 2.0) |
| Laboratory Standards Team | (LAB) |
| Standard for Exchange of Non-clinical Data | (SEND V2.3) |
| Case Report Tabulation Data Definition Specification (define .xml) | (CRT-DDS V1.0) |
| Terminology | (Terminology) |
Standards in Development
| Submission Data Standards Team | SDTM IG V3.1.2 Draft SDTM V1.2 Draft Metadata Submission Guidelines, Appendix to the SDTM IG V3.1.1 |
| Protocol Representation Group | (PRG) |
| Clinical Data Acquisition Standards Harmonization (CDASH) | (CDASH) |
| Terminology | (Terminology) |
| Cardiovascular and Tuberculosis Data Standards | (Cardiovascular and Tuberculosis Data Standards) |
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