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 NIH-funded studies (including both biomedical and behavioral.)

An Applicable Clinical Trial 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) if they are serving the role of Sponsor or Sponsor-Investigator (see definitions here https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3 In most cases, the role of Sponsor-Investigator must closely involve the medical expertise of a qualified physician. All roles must be clearly outlined in the Institutional Review Board (IRB) application.
  • Applicable Clinical Trials have stringent requirements for registration and reporting under the Food and Drug Administration Amendments Act (FDAAA) of 2007. 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 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. 

The NIH Clinical Trial Definition is:

“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 found here https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html).

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.

Links to requirements, tips, and tools for Purdue University investigators are included as content in the Getting Started and Frequently Asked Questions section of this website.