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This is the original public announcement from 2019. This pilot is closed. Results will be posted in the future. Contact Lou Ann Kramer or Ben Sefing for information. Lou Ann Kramer , Benjamin Sefing |
The CDISC1 Standard for Exchange of Nonclinical Data for the Center for Biologics Evaluation and Research (SEND for CBER) Working Group is requesting from the public, realistic toxicology study examples to support conducting a Proof-Of-Concept (POC) for implementation of SEND for submissions to FDA CBER offices. The purpose of the POC is to familiarize FDA CBER reviewers with complete studies in SENDIG v3.1 format and allow them to explore ways of reviewing data in this format, using tools in development at FDA. For example, reviewers could use the POC datasets to view and analyze aspects of study review in SAS JMP, or technicians at FDA can determine how the datasets will be loaded into FDA databases or other tools. The participating offices from CBER are:
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