CDISC

The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization whose contribution to global health is developing a common language for clinical research.

CDISC Study Data Standards eCTD Submissions

As it relates to clinical data included in eCTD submissions filed to regionl health agencies like the U.S. Food & Drug Administration (US FDA) and European Medicines Agency (EMA), CDISC believes the ultimate goal is “creating regulatory submissions that allow for flexibility in scientific content and are easily interpreted, understood and navigated by regulatory reviews.”

The standards put forth by CDISC used to submit clinical data include the Study Data Tabulation Model (SDTM), the Standard Exchange for Nonclinical Data (SEND) and the Analysis Data Model (ADaM). SDTM has been the FDA’s preferred regulatory submissions standard for clinical trials since July 2004 and nonclinical studies since July 2011.

On December 17, 2014, the FDA released binding guidance documents that will require, not just recommend, the submission of clinical data in a standard format in the near future. The FDA Data Standard Catalog (DSC) will provide the support data, support end date, requirement data for each standard.

When the FDA announced its intent to require CDISC standards many years ago, then Commissioner Lester M. Crawford said, “The importance of standard for the exchange of clinical trial data cannot be overstated. FDA reviewers spend far too much valuable time simply reorganizing large amounts of data submitted in varying formats. Having data presented in a standard structure will improve FDA’s ability to evaluate the data and help speed new discoveries to the public.

Study Data Standards Resources

Guidance for Industry – Providing Regulatory Submissions in Electronic Format — Standardized Study Data

Data Standards Catalog

Study Data Technical Conformance Guide v2.3