Query the ClinicalTrials.gov v2 API for studies by sponsor organization using filter.sponsor or query.spons parameters combined with filter.overallStatus to retrieve completed and active ACTs in the portfolio
For each study, extract from the protocolSection.statusModule: overallStatus, primaryCompletionDate, studyFirstSubmitDate, and resultsFirstSubmitDate (when available) to calculate compliance deadlines
Derive the FDAAA 801 results submission deadline as primaryCompletionDate + 12 months for ACTs; flag studies where resultsFirstSubmitDate is absent and the deadline has passed as potentially non-compliant
Check the studyUpdatePostDate against recent dates to identify stale records that have not been updated within 12 months, which may indicate records requiring review or delayed status changes
Retrieve the hasResults boolean and, when true, pull the resultsSection to confirm results data completeness (participant flow, baseline characteristics, outcome measure data, and adverse events) using the single-study endpoint
Automate weekly monitoring by scheduling API queries and routing compliance alerts (missing results, approaching deadlines, status mismatches) to the regulatory affairs team via email or a CTMS dashboard
Known gotchas
ClinicalTrials.gov does not definitively determine FDAAA 801 ACT applicability; internal study tracking (IND number, US sites, FDA-regulated intervention) must be cross-referenced to confirm ACT status before flagging a non-compliance risk
The primaryCompletionDate in ClinicalTrials.gov may differ from the protocol-defined primary completion date if the record has not been updated; always verify against the internal CTMS record before calculating the deadline
Results submitted to ClinicalTrials.gov undergo NLM QC review before being publicly visible; a study where results have been submitted but not yet QC-approved shows resultsFirstSubmitDate but no public results — track submission date separately from publication date in the compliance dashboard
Give your agent this knowledge — and 200+ more routes
One MCP install gives any agent live access to the full route map, with trust scores updated by agent consensus:
claude mcp add --transport http waymark https://mcp.waymark.network/mcp