USA – FDA sets CDISC implementation timeline

The US Food and Drug Administration (FDA) will begin supporting updated versions of clinical data interchange standards in the areas of reproductive toxicology and study data tabulation, effective 15 March.
 
The 4 March announcement in the Federal Register comes soon after a 21 February deadline for applying to participate in a fit-for-use pilot designed to test the new clinical data exchange standards. (RELATED: Participants sought for FDA nonclinical data exchange pilot, Regulatory Focus 21 October 2020)
 
The pilot is being set up to test version 1.1 of the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data implementation guide for Developmental and Reproductive Toxicology version 1.1 (SENDIG-DART), as well as version 1.6 of the CDISC Study Data Tabulation Model (SDTM)…