Training and Education

CDISC (Clinical Data Interchange Standards Consortium) is an organization that develops industry standards. The standards support the electronic acquisition, exchange, and archival of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC defines several data models for the interoperability of clinical data exchange. The mission of CDISC is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of health care.

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SDTM stands for Standard Data Tabulation Model defined by Clinical Data Interchange Standards Consortium (CDISC). SDTM defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted to a regulatory authority like FDA as part of a product application. SDTM standard is widely used in the industry, such requirements were standardized and are broadly shared. SDTM should be followed by Data Manager while designing eCRF. SDTM bridges the gap between data manager and statistician by eliminating the dependency of statistical programmer. Particular requirements of statisticians and modeling scientists for data formats are known and understood by SDTM. SDTM increase the efficiency of the drug development process. SDTM gives a more consistent and robust CDM approach compared to collecting the clinical data in CDISC standard.

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ADaM stands for Analysis Data Model defined by Clinical Data Interchange Standards Consortium (CDISC). ADaM defines a standard for Analysis Dataset’s to be submitted to the regulatory authority like FDA. This provides a clear content, source, and quality of the datasets submitted in support of the statistical analysis performed by the sponsor. The principle of clear and unambiguous communication, relies on clear AD's (Analysis datasets) documentation. ADaM helps to standardize this documentation.