FDA-Regulated Studies
The FDA defines a clinical investigation as "any experiment that involves a test article and one or more human subjects," when the test article is or would be FDA-regulated. To determine if a study is FDA-regulated, the Quality Assurance team conducts ancillary reviews for studies using investigational drugs and devices to determine the applicability of FDA regulations. For the FDA, clinical investigation is synonomous with research, clinical research, clinical study, and study. Clinical research that also meets the definition of an "Applicable Clinical Trial" (ACT) must meet additional regulatory requirements for the FDA.
All ACTs must be registered and have result reported on ClinicalTrials.gov, a public registry and results database overseen by the National Library of Medicine. By ORP policy, ACTs must be registered within 21 days of IRB approval. By federal regulations, active registrations must be updated and verified regularly and no less than every 12 months. Results must be reported within 12 months, respectively, of final data collection for the primary outcome and final data collection for the study as a whole.
Please see our page on ClinicalTrials.gov for more details on registration and reporting requirements.
Applicable Device Clinical Trial
"Applicable Device Clinical Trial" is a controlled study using an FDA-regulated device, excluding feasibility studies.
- Device studies that do not require pre-market notification or appoval (i.e. are 510(k) exempt) are excluded from this definition.
- The FDA defines feasibility studies as studies intended only to confirm the design and operating specifications of a device. Feasibility studies do not measure health outcomes.
- The FDA's definition of "controlled" for device studies is broad. It includes studies with non-concurrent controls such as historical controls (e.g., literature, patient records), validated objective outcomes using objective performance criteria (criteria based on broad sets of data from historical databases) that are generally recognized as acceptable values, or participants as their own control.
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The definition does not apply to research using only de-identified human specimens.
Applicable Drug Clinical Trial
"Applicable Drug Clinical Trial" is a controlled study using an FDA-regulated drug or biologic, excluding phase 1 studies and, in most cases, basic science.
- Federal regulations indicate that the types of controls generally used in clinical investigations are placebo concurrent control, dose-comparison control, no intervention concurrent control, active intervention concurrent control, and historical control.
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Historical control includes comparing results to literature, patient records, or the participants' baseline data, meaning the participant serves as his or her own control.
More information on applicable clinical trials can be found in the publication "The Elaboration of Defintions of Responsible Party and Applicable Clinical Trial.
Resources
Investigational Device Exemption (IDE)
IDE Annual or Final Report Template
Investigational New Drug (IND)
Preparing for FDA Inspections
Investigators Guide - Preparing for a Regulatory Agency Site Inspection