What is CDISC and SDTM? | HCL Technologies

TECHNOLOGY Q&A

Clinical Trial Data migration to CDISC SDTM

What is CDISC and SDTM?

CDISC stands for the Clinical Data Interchange Standards Consortium. It is a global not-for-profit organization that develops data standards for the pharmaceutical industry.

Study Data Tabulation Model (SDTM) defines a standard structure for human clinical trial (study) data tabulations and for non-clinical study data tabulations, that are to be submitted as part of a product application, to a regulatory authority such as the United States Food and Drug Administration (FDA).

What is CDISC ODM?

CDISC ODM is a vendor-neutral, platform-independent format. It supports the electronic acquisition, exchange, and archival of clinical trial data for the medical and biopharmaceutical industries.

What are SDTM and ADaM datasets?

The SDTM data sets provide standards for organizing clinical trial data following database lock. The ADaM data sets provide a connection between the SDTM data sets and the final statistical analyses. In conclusion, these concepts are simply standards for clinical trial data.

The Clinical Data Interchange Standards Consortium (CDISC) defines standards to deal with medical research data linked with life sciences, to "enable information interoperability to improve medical research and related areas of life sciences". The standards support medical research from protocol through analysis and reporting of results, and have been shown to decrease resource-needs by 60% (overall) and 70–90% (in the start-up stages) when they are implemented at the beginning of the research process.