Which Trials Must Be Registered in ClinicalTrials.gov?
Jul 8, 2021
1.Trials that meet the FDAAA 801 definition of an "Applicable Clinical Trial".
2.All NIH-funded clinical trials, per NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, if the study started AND the application for funding was submitted on or after 1/18/2017.
- The requirement applies regardless of study phase, type of intervention (including behavioral interventions), or whether they are subject to the Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11
- NIH defines "Clinical Trial" as:"a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."
3.Clinical trials intended to be published in an International Committee of Medical Journal Editors(ICMJE) member journal that meet the ICMJE definition of a clinical trial (per their policy).
- ICMJE defines "Clinical Trial" as: any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome".
- ICMJE policy requires that studies be registered prior to the start of enrollment.
4.Studies otherwise required to be registered by the funder (e.g. other Federal agencies or departments, Bill & Melinda Gates Foundation) or by the policies of individual academic journals.
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