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Policies and Guidance

Clinical Trials Registration

All clinical trials which meet either the FDA or International Committee of Medical Journal Editors (ICMJE) definition of “clinicaltrials.gov's” must be registered on clinicaltrials.gov's website. Our Guidance on ClinicalTrials.gov Registration explains the requirements associated with registration (who, what, when, and how), and the penalties for failing to meet those requirements.  Please see https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/clinical_trials.html for help in registering your clinical trial on clinicaltrials.gov's