When to Register your Study on ClinicalTrials.Gov
Jul 2, 2020
When to Register your Study on ClinicalTrials.Gov
Question: When should I register my study?
Answer: Generally, BEFORE you begin enrollment.
If the study is an Applicable Clinical Trial, the study must be registered within 21 days of enrollment of the first subject in accordance with FDAAA 801 and Final Rule (42CRF11) Requirements.
HOWEVER, NIH-supported clinical trials, and clinical trials that will be published in ICMJE-affiliated academic medical journals are subject to those organizations’ policies. Those policies require that clinical trials be registered before the first subject is enrolled.
For more information, please see:
- The International Committee of Medical Journal Editors (ICMJE) Policy on Clinical Trial Registration
- The NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
For more information, please visit our ClinicalTrials.gov support page, where you can download step-by-step instructions for registering your study on ClinicalTrials.gov.
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registration