Reviewing studies involving drugs, biologics, devices
FDA regulations apply to any study that meets the FDA’s definition of a clinical investigation involving human subjects. This section of the staff manual describes how IRB analysts use Toolkit and campus FDA resources to identify during pre-review when FDA regulations apply to a study, determine when an FDA-regulated study is review ready, and make recommendations to the IRB regarding how to apply the regulations.
Definitions
Clinical Investigation: Per 21 CFR 50.3(c), a clinical investigation means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58, regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, and clinical investigation are deemed to be synonymous for purposes of this part.
Human Subject: 21 CFR 50.3(e) Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. 21 CFR 50.3(j) A test article means any drug for human use, biologic product for human use, medical device for human use, human food additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act.
FDA regulations apply differently to drugs and devices and even with Toolkit resources as a guide, determining whether and how to apply the regulations can be difficult. UW-Madison has resources dedicated to assisting researchers with FDA compliance: ICTR IND/IDE Consultation Service (I3CS) and UW FDA-Regulated Research Oversight Program (FDARROP). I3CS responds to questions regarding whether and how FDA regulations apply in specific situations. FDARROP oversees registration of UW investigator-held INDs and IDEs, sponsor-investigator training for these investigators, and quality assurance reviews for research with investigator-held INDs/IDEs. IRB analysts should direct study teams to these resources as needed and also consult I3CS/FDARROP about any drug or device questions during the review process.
Reviewing Studies Involving Drugs and Biologics
Reviewing Studies Involving Medical Devices
Studies Requesting to Rely on an External IRB
RELIANT will contact FDARROP for any UW held IND/IDE studies and use the HRP-834 WORKSHEET Institutional Requirements for Ceded Studies to work with study teams on identifying UW requirements such as registering through the FDA Regulated Research Oversight Program.
Additional considerations
- Obtaining identifiable private information or biospecimens for the purposes of screening, recruiting, or determining study eligibility does not fit FDA’s definition of a clinical investigation. For that reason, similar to studies under the Revised Common Rule, FDA regulated studies do not require informed consent for recruitment activities such as pre-screening of medical records or screening questionnaires to determine eligibility.
- Use HRP-309 Ancillary Review Matrix to check for ancillary review requirements that may apply to certain types of drugs/biologics, such as Radiation Safety review for radiopharmaceuticals. While study teams are responsible for obtaining all required ancillary approvals, as a courtesy IRB analysts can refer study teams to HRP-309 and applicable review requirements.
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