FDA updates bioresearch monitoring e-submission guide
A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration.The guide provides detailed information for electronic submission of clinical trial data (e-CTD) by sponsors in advance of submissions for new drug applications, biologics license applications, and supplemental submissions. The technical specifications document delineates details of the electronic submissions framework laid out in a related draft guidance, Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions.
The document, originally issued in December 2017, has been updated with primarily technical adjustments. The document now has more consistency in how variables are named in the tables and in explanatory examples. Additional clarification about documents, listings, and data requests was provided as well. The update also adds some variables and revises or removes others in the instructions for electronic submission.
The guide provides "current FDA specifications, recommendations, and general considerations" for sponsors who are preparing and submitting electronically both clinical study-level information and subject-level data line listings by clinical site, as well as summary-level clinical site datasets that will be used by the Center for Drug Evaluation and Monitoring (CDER) to plan bioresearch monitoring (BIMO) inspections.
FDA Technical Specifications Document