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.
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."
Please contact your NIH program officer if you are unsure if your study qualifies as a clinical trial.
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.
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.
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:
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."