Trial Registration
The public documentation of a clinical trial's existence, design, and key information before or shortly after enrolment begins. Trial registration on databases like ClinicalTrials.gov and EU Clinical Trials Register is mandatory for most trials and promotes transparency and accountability.
Technical Context
Registration requirements: FDAAA 801 mandates registration of interventional trials of FDA-regulated drugs/biologics/devices within 21 days of first patient enrolment. WHO/ICMJE requires registration before first patient enrolment as a condition of journal publication. Information registered includes: descriptive information (title, sponsor, conditions, interventions), recruitment information (eligibility criteria, enrollment target, locations), design information (study type, phase, masking, allocation, endpoints), and administrative information (IND/IDE number, responsible party). Results reporting requirements mandate submission of summary results within 12 months of primary completion. Non-compliance with registration/reporting requirements can result in civil penalties up to $10,000/day and withholding of NIH funding.