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
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)
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
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
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
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
Known gotchas
The responsible party is the sponsor-investigator or designated PI, not the institution; the ClinicalTrials.gov account holder for the record must have legal authority to submit on behalf of the sponsor
Protocol amendments that change primary outcome measures require updating ClinicalTrials.gov before the change is implemented at sites; post-hoc outcome changes that differ from the registered primary outcome are flagged by FDA and journals as potential outcome reporting bias
Results submission is a separate action from registration; many sites register the trial but miss the 12-month results deadline because PRS does not proactively notify the responsible party — implement a calendar trigger at primary completion date
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claude mcp add --transport http waymark https://mcp.waymark.network/mcp