Clinical Trials
Registration Requirements for Clinicaltrials.gov
The definitions of “Clinical Trial” and “Applicable Clinical Trial” differ, but are central to knowing what is required in certain federally-funded studies (including both biomedical and behavioral interventions).
Investigators whose studies do not meet the definition of Applicable Clinical Trial may still encounter registration requirements based on the NIH definition of Clinical Trial. This definition encompasses a much broader set of studies. Researchers must review the NIH policy definition to gauge potential impact on their upcoming research activities. Click on the sections below to review the definitions.
Both biomedical and social behavioral researchers must be aware of these requirements. The Federation of Associations in Behavioral and Brain Sciences (FABBS) provides a comprehensive overview of NIH communications, guidance, and resources related to the expanded clinical trial requirements.
Utilizes research with human subjects and a drug, device, or biologic. An interactive flow chart about this definition is available from NIH at this link: https://grants.nih.gov/ClinicalTrials_fdaaa/ACTs_under_FDAAA.htm
Investigators whose studies meet this definition may also be required to apply to the Food and Drug Administration (FDA).
Applicable Clinical Trials have stringent requirements for registration and reporting under the Food and Drug Administration Amendments Act (FDAAA) of 2007.
“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.” (Reference NIH NOT-OD-15-015.
Notice that a study does not require use of a drug, device, or biologic to fit under the NIH definition. NIH-funded clinical trials must be registered in Clinicaltrials.gov under the Purdue University account.