CDISC

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) (SDTM V1.1) (SDTM IG V3.1) WebSDM edit checks for  (SDTM 3.1.1)
Operational Data Modeling Team	(ODM V1.3) (ODM V1.2.1) 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)