A clinical trial is a study that is characterized to include:
- Prospective assignment of human subjects
- One or more interventions, and
- Identification of one or more health-related biomedical or behavioral outcomes
For more information see the NIH definition of clinical trial at the Office of Science Policy.
Studies that propose to conduct a clinical trial at the time of application submission must include with the application:
- Protection of Human Subjects section that describes all of the human subjects components of the study
- Data and Safety Monitoring Plan (DSMP), which may involve the creation of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for NIH-Defined Phase III clinical trials
- Inclusion of Women and Minorities
- PHS Inclusion Enrollment Report(s)
- Inclusion of Children
Conducting an international clinical trial? Finding clinical trial regulations has never been easier! Visit NIAID’s revamped ClinRegs website and explore regulations for 17 different countries in a single place. The site’s improved navigation includes a table of contents for regulatory topics, easy toggling between single country and comparison views, a Quick Facts table with discrete pieces of information for each country, and an easy way to provide feedback on country content.
Policy Updates: New HHS rule and NIH policy, effective January 18, 2017, affects all NIH-funded clinical trials. Under the NIH Policy, all clinical trials funded in whole or in part by NIH, regardless of study phase or type of intervention will be expected to register at ClinicalTrials.gov and report findings. Read the summary. For information about ClinicalTrials.gov, the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information, and the expansion of the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Clinical Trials Registration and Results Information Submission) click here.
Additionally, the NIH has also published a policy, effective January 1, 2017, that establishes the expectation that all NIH-funded investigators who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with the principles of the International Conference on Harmonisation (ICH) E6 (R2). Click here for the full policy.
Lastly, NIH has published the Policy on Funding Opportunity Announcements (FOA) for Clinical Trials. Starting with application due dates on or after January 25, 2018, NIH will require that all applications involving one or more clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designed for clinical trials. This means that the NIH will no longer accept clinical trial applications through “parent” FOA announcements or through other FOAs that are not specifically designed to accept clinical trials.