FDA Piloting New Data Standards for Studies

FDA website

The Food and Drug Administration (FDA) is creating a pilot program to test new data standards for the data collected in non-clinical studies funded by the agency, FDA announced in an upcoming Federal Register post.

The post, released for public inspection on August 19, notes that FDA is deciding whether to extend the Standard for Exchange of Nonclinical Data (SEND) 3.1, created by the Clinical Data Interchange Standards Consortium (CDISC). FDA’s Center for Drug Evaluation and Research (CDER) is specifically looking to apply SEND 3.1 to nonclinical toxicology data.

“SEND 3.1 is included in the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future. This pilot will evaluate the compliance of sample SEND 3.1 datasets submitted to CDER,” FDA states.

As an example of how the pilot may function, FDA said that it piloted the SEND 3.0 standards, submitting feedback to shift how the standards work and requiring them in December 2016. The pilot led to improvements in the implementation guidance, and the current pilot will also work with CDISC to update implementation guidance.

FDA is looking for five participants to participate in the six-month pilot by submitting SEND 3.1 datasets along with study packages, with a focus on datasets that “highlight the most significant changes from [SEND 3.0] to [SEND 3.1].” Applications will remain open until September 19.

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