NIH: Updated Information, Tools, and Resources Regarding the Definition of a Clinical Trial
- New PHS Human Subject and Clinical Trial Information form. Required for application due dates of January 25, 2018, and beyond.
- Current NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental,pilot/feasibility, behavioral, and more.
- NIH policy changes related to enhancing stewardship of clinical trials, including requirement to apply to an FOA that specifically allows for the submission of clinical trial applications, training expectations, and peer review criteria.