Clinical Trials.gov - Trial Record Life-cycle

Trial Record Life-cycle

The trial typically goes through stages of: initial registration, ongoing record updates, and basic summary result submission. Each trial record is administered by trial record manager. A trial record manager typically provides initial trial registration prior the study enrolls the first participant. This also facilitates informing potential participants that the trial is no longer recruiting participants. Once all participants were recruited, the trial record may be updated to indicate that is closed to recruitment. Once all measurements are collected (the trial formally completes), the trial status is updated to 'complete'. If the trial terminates for some reason (e.g., lack of enrollment, evidence of initial adverse outcomes), the status may be updated to 'terminated'. Once final trial results are known or legal deadlines are met, the trial record manager may upload basic summary results to the registry either by filling a complex web-based form or submitting a compliant XML file.