Clinical Trials

Page Contents

  1. Clinical Trial Definitions
  2. Clinical Trial Requirements

IMPORTANT NOTICE: The Food and Drug Administration (FDA) has released guidance on how clinical trials shall be conducted during the COVID-19 pandemic. Please CLICK HERE to read the guidance and see how this may impact your clinical trial.

Clinical Trial Definitions

 

FDA Definition of a Clinical Trial

Registration at ClinicalTrials.gov is required for trials that meet the Food and Drug Administration Amendments Act of 2007 (FDAAA) section 801 definition of an “Applicable Clinical Trial”, which includes the following:

  1. Controlled clinical investigations (other than phase 1 investigations) of any U.S. Food and Drug Administration (FDA)-regulated drug or biological product for any disease or condition.
  2. Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric post-market surveillances of a device product.

Applicable clinical trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:

  • The trial has one or more sites in the United States;
  • The trial is conducted under an FDA investigational new drug application or investigational device exemption;
  • The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

OHRP Definition of a Clinical Trial

A federally funded 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.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

NIH Definition of a Clinical Trial

An NIH funded 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.

NIH applications/proposals involving clinical trials with due dates on or after January 25, 2018 must be submitted to an FOA or request for proposal (RFP) that explicitly states it will accept clinical trials.

NIH Special Considerations

The NIH has special considerations for Training, Fellowship, and Career Development Awards. Please see below:

  • Institutional Training awards do not support clinical trials (with the exception of some D43 and K12 awards).
  • The NIH encourages fellows to receive training in clinical research, however, NIH supported fellows are not permitted to conduct a clinical trial independently.
  • Career Development awards may support either independent clinical trials or a mentored research training experience, depending on the FOA.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

 

 

ClinicalTrial.gov Requirements

 

FDAAA (the FDA) and NIH Clinical Trial Requirements

Both FDAAA (the FDA) and the NIH have similar requirements for studies that are defined as clinical trials under their policies.  Please see the policies below:

  • Applicable clinical trials and NIH clinical trials are required to be registered on clinicaltrials.gov within 21 days after the first subjects has been enrolled (with few exceptions).
  • Applicable clinical trials and NIH clinical trials are required to be updated at least once every 12 months.
  • Applicable clinical trials and NIH clinical trials are required to post results no later than one year after the clinical trial completion date (with few exceptions).

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

OHRP Clinical Trial Requirements

The Office of Human Research Protections requires all clinical trials as defined in the Common Rule (45 CFR 46.102(b)) must post a consent form that was used in the trial.  Only one consent form needs to be posted and revised versions do not need to be uploaded. The consent form should only be posted if the actual document had been used to enroll a subject (signed consent forms should not be posted).

Furthermore, the timeline for when the consent form should be posted is between the date that recruitment was closed and 60 days after the last study visit by an enrolled subject as required by the protocol. If the consent form is posted after 60 days after the last study visit, or before recruitment is closed, then the federal requirement to post the consent form is considered unmet.

To learn more about how to register, maintain, or submit reports in clinicaltrials.gov, please see our Clinical Trials Procedures Page.

 

Please do not hesitate to contact the Regulatory Affairs and Clinical Trials Office should you have any questions about these important requirements.