Clinical Trials

New Requirements for Clinical Trials

Effective July 19, 2018:  For each clinical trial conducted, one IRB-approved informed consent form used to enroll subjects must be posted on a publicly available Federal website. The informed consent form must be posted after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.

Effective January 25, 2018:  Applicants seeking NIH funding for a clinical trial will be required to submit the application through a Funding Opportunity Announcement (FOA) or Request for Proposal (RFP) that accepts clinical trials. Applicants will also be required to use the new PHS Human Subject and Clinical Trial Information Form (part of the NIH funding application package, Forms-E).


What is a Clinical Trial?

A clinical trial is defined 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.

Determine if you are conducting a clinical trial


ClinicalTrials.gov Registration

The following types of clinical trials require registration on ClinicalTrials.gov:

  • An NIH funded clinical trial; or
  • An FDA regulated clinical trial involving drugs, devices, or biologics.

All other clinical trials (those without NIH funding and those not FDA regulated) are still encouraged to register on ClinicalTrials.gov.

Learn more about the ClinicalTrials.gov Registration process


Good Clinical Practice (GCP) Training

All researchers that are engaged in conducting one or more of the following types of research studies are required to complete online GCP training (in addition to the regular CITI IRB training):

  • An NIH funded clinical trial; or
  • An FDA regulated clinical trial involving drugs, devices, or biologics.

GCP training can be completed through the CITI Program website. GCP training reports are valid for a period of three years and must be renewed at the end of that three year period.


Other Clinical Trial Resources