NIH-Funded Clinical Trials

NIH-funded clinical trials must comply with specific NIH policies. Please review the information below to determine if your study qualifies as a clinical trial and for guidance on compliance with related policies.

 

NIH Definition of "Clinical Trials"

Effective January 25, 2015, NIH defines 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 those interventions on health-related biomedical or behavioral outcomes."

Review this decision tree and these case studies for help in determining if your study qualifies as an NIH-funded clinical trial.

 

Good Clinical Practice Training

Effective January 1, 2017, NIH requires all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of NIH-funded clinical trials to be trained in Good Clinical Practice (see NIH Policy on Good Clinical Practice for NIH Awardees Involved in NIH-funded Clinical Trials). This policy applies to all currently NIH-funded as well as all future NIH-funded clinical trials. Investigators are not required to retake GCP training during their study (unless required by local regulations or by their sponsor).

 

GCP Training Course

GCP training is available for investigators and clinical trial staff through NYU's CITI program. See How to Register and take the NYU CITI GCP course for instructions on accessing and registering for CITI's GCP training: Social and Behavioral Research Best Practices for Clinical Research.

 

Registering Studies with ClinicalTrials.gov

Effective January 18, 2017, NIH-funded clinical trials must register with ClinicalTrials.gov.

ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

To ensure compliance with the NIH policy, NYU requires that:

  • Clinical trials are registered at ClinicalTrials.gov at the time of IRB review.
  • Results information from clinical trials is submitted to ClinicalTrials.gov not later than one year after the trial's primary completion date (i.e., the date of final data collection for the primary outcome measure).
  • Consent forms include the following text: "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

NIH funding proposals are required to include a plan outlining how applicants will comply with the policy. NYU recommends that the following text be used to describe the plan: "In compliance with NIH policy, this clinical trial will be registered with ClinicalTrials.gov. Registration will occur at the time of IRB review and results information will be submitted not later than one year after the trial's primary completion date. Additionally, the relevant informed consent documents will include a specific statement relating to posting of the clinical trial information at ClinicalTrials.gov."

 

 

For questions about ClinicalTrials.gov, please contact:

Deborah Zarin, M.D., Director, ClinicalTrials.gov
(301) 451-4634
dzarin@mail.nih.gov