The U.S. National Library of Medicine has updated the Clinicaltrials.gov FAQs to address expanded access and all-cause mortality. The expanded access FAQs cover:
- What is Expanded Access?
- Who is required to submit expanded access information to ClinicalTrials.gov and what information is required?
- When is expanded access information required to be submitted to ClinicalTrials.gov?
The all-cause mortality question addresses which deaths must be submitted as part of clinical trial results information. Applicable clinical trials (ACTs) with a Primary Completion Date on or after January 18, 2017, must provide this information to ensure all collected participant deaths that occurred during the course of the trial are accounted for.
Visit the Clinicaltrials.gov FAQs to review general questions as well as the specific inquiries about the Protocol Registration and Results System, Section 801 of the Food and Drug Administration Amendments Act, and the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).
