Clinical Trials

The Quality Assurance program provides support for investigators who need to comply with the federal regulations and policies pertaining to clinical research, including FDA-regulated studies and NIH-funded clinical trials.  A number of federal funding agencies, including the NIH, share a definition of "clinical trial" that is codified in federal regulations effective January 21, 2019.  These regulations define a 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 the interventions on biomedical or behavioral health-related outcomes."  

The regulatory definition is intentionally broad, covering a wide range of research not traditionally considered a clinical trial.  A study does not need a "clinical endpoint" to meet this regulatory definition of a clinical trial.  The definition includes basic science, mechanistic studies, and social and behavioral research.  There may be exceptions, but research that is purely observational or that is simply an analysis of pre-existing data generally does not meet the definition of "prospectively assigned."

The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices and biologics.

For more information about NIH clinical trials and for help determining if your study meets the definition of a clinical trial, refer to this guidance.  To determine if your study is an FDA-regulated clinical trial, which is called an Applicable Clinical Trial, see the guidance on FDA-regulated studies.  

Federal Regulations

Federal regulations require that an investigator receiving federal funding for a clinical trial, except clinical trials sponored by the NIH or FDA, post any consent form approved by the IRB any time after recruitment closes but not later than 60 days after the last study visit by any subject.  The consent form must be posted on a publicly available federal repository.  Studies approved by the IRB before January 21, 2019 are not subject to this requirement.

For clinical trials approved on or after January 21, 2019, investigators can choose to use for this purpose or post the consent form to a docket folder on Docket ID: HHS-OPHS-2018-0021

For registration on, please see our policy and instructional page.  Studies registered for the purpose of this federal agency requirement are subject the ORP policies and requirements for voluntary registrations.

Review these instructions for post to the docket folder and refer to the Consent Form Posting guidance for additional information. 

Please contact us at or 814-865-1775 with any questions realted to FDA-regualtions or clinical trials.  For investigators affiliated with the College of Medicine, please contact for questions about ACTs and NIH-funded clinical trials.  Your IRB Analyst will help you with this definition when you submit a new study for IRB approval.

GCP Training

All study team members on any study determined to be a clinical trial must complete Good Clinical Practice (GCP) training before a study can receive IRB approval, and the training must be refreshed every 3 years. This is in addition to the human subjects training required by the IRB, which also must be refreshed every 3 years. Penn State offers GCP training through the CITI Program. Please see our our instructions for how to access the training.