If a research study meets any one of the following definitions, the trial must be registered on ClinicalTrials.gov:

• The Food and Drug Administration (FDA) requires registration for “applicable clinical trials” (ACTs) defined as follows:
  • For any trials of drugs and biologics:  controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulation.
  • For trials of biomedical devices:  controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post-market surveillance.
• International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

If you are uncertain whether or not your study meets the definition of a clinical trial (as defined above), please register the study to ensure compliance with the regulations. However, please note that if you register a research study with ClinicalTrials.gov, even inadvertently, you will be responsible for completing the entry and updating the information throughout the course of the trial according to the FDA requirements.

In order to be compliant with regulations in regards to ClinicalTrials.gov, your study needs to be posted on the public website and assigned a NCT number (ClinicalTrials.gov Identifier) prior to enrollment of the first study subject.

 Common Delays

• Not both “Approving” and “Releasing” the study for review with ClinicalTrials.gov (this is two-step process).
• Not addressing QA Review Comments regarding studies after initial ClinicalTrials.gov review.

Important Note

Periodically check the status of your study in Clinicaltrials.gov for any problems, errors, or warnings identified by Clinicatrials.gov.

If you have specific questions or need to address an issue concerning ClinicalTrials.gov registration, please send an email to register@clinicaltrials.gov with your question or description of the problems you are encountering.

Bridget Strong, Director OCR, Education and Outreach