FDA sets CDISC implementation timeline

Regulatory NewsRegulatory News | 08 March 2021 |  By 

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).
Sponsors will have an additional 1 to 3 years before they are required to use these formats for electronic submissions: CDISC SENDIG-DART is the required format for new drug applications, abbreviated new drug applications and some biologics license applications beginning 15 March 2023. Certain investigational new drug applications will need to start using the new standards a year later, on 15 March 2024.
Use of version 1.6 of CDISC SDTM will be required in just one year, on 15 March 2022.
Study data standards are already required for study data submitted to the agency’s Center for Drug Evaluation and Research (CDER), according to existing FDA guidance. Current efforts to standardize study data reporting afford regulators, researchers and sponsors “a consistent general framework for organizing study data, including templates for datasets, standard names for variables and a standard way of doing calculations with common variables,” said FDA in announcing last fall’s pilot.
Federal Register


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