Register a clinical trial on ClinicalTrials.gov to meet FDAAA 801 deadlines and submit results

Steps

1. Determine Applicable Clinical Trial (ACT) status: a trial is an ACT if it is a controlled, interventional study of an FDA-regulated drug, device, or biologic conducted in the US or under an IND/IDE, regardless of sponsor type
2. Register no later than 21 days after enrolling the first participant by submitting required registration data elements including intervention name, condition, study type, phase, enrollment target, primary completion date, and primary outcome measure(s) via the ClinicalTrials.gov Protocol Registration and Results System (PRS)
3. Update the record within 30 days of any change to a primary registration field (primary outcome measure, enrollment, study design, or completion date); document the update reason, as the system timestamps all changes
4. After the primary completion date (last participant's last data collection visit for the primary outcome), submit results within 12 months: participant flow, baseline characteristics, outcome measure data, adverse events table, and point-of-contact information
5. For studies with a certification of good cause delay, submit the certification before the results deadline and resubmit every year; without a valid certification, the record is marked non-compliant on the ClinicalTrials.gov public page
6. After submission, monitor PRS for QC review comments from the NLM staff and respond within 15 business days to avoid automatic rejection of result records