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PDF: Brief CT.gov Registration Highlights

Trial Registry Overview Chart

Register WHEN? Phase 1 Phases 2-4 Device Other Interventional* Observational Post Results?
ICMJE Before enrollment of 1st subject Yes Yes Yes Yes No No
NIH Within 21 days of 1st subject’s enrollment Yes Yes Yes Yes No Yes
FDA Within 21 days of 1st subject’s enrollment No Yes Yes No No Yes
CMS Prior to claims submission (for Qualifying Clinical Trials) Yes (if qualifying) Yes Yes No No No
* Health-related or Behavioral Interventional Trials. Go back.