IS YOUR STUDY A CLINICAL TRIAL?
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. Correctly identifying whether your study is a clinical trial is crucial in complying with NIH policies and Michigan Medicine.
If you answer yes to the following questions, then your study qualifies as a clinical trial:
- Does the study involve one or more human subjects?
- Does the study involve the use of one or more interventions?
- Does the study prospectively assign human subject(s) to an intervention(s)?
- Does the study have a health-related biomedical or behavioral outcome(s)?
Learn more about the NIH Clinical Trial Definition at nih.gov.
HOW WE SERVE YOUR CLINICAL TRIAL NEEDS
Feasibility Review Support
The Feasibility Review, conducted by the appropriate CTSU, looks at the whole picture of a potential clinical trial to prevent unexpected challenges in its execution and to open to accrual in a timely manner. LEARN MORE.
Clinical Trials Support Units keep studies on track during the pre- and post-award process. A CTSU portfolio manager follows a study along its lifecycle and assists teams on their path to study activation. LEARN MORE.
Study Coordinator Support
Principal Investigators can ultimately find a smoother process and save time by taking advantage of our study coordinator pool, which can provide investigators with team members who are already on staff and fully trained. LEARN MORE.
FACULTY AND STAFF