This policy describes the procedures that UW–Madison follows to provide oversight of clinical trials for which a UW–Madison investigator holds an investigational new drug (IND) and/or investigational device exemption (IDE).
Policy:
The UW–Madison FDA-Regulated Research Oversight Program uses routine reviews to ensure that clinical trials under a UW–Madison investigator-held IND or IDE are conducted in compliance with applicable laws, regulations, policies, and guidelines.
Clinical trials that meet the following criteria will undergo periodic routine reviews:
Clinical trials for which a UW–Madison investigator holds an IND or IDE; and
Clinical trials that have been Institutional Review Board (IRB)-approved, opened to accrual, and enrolled subject(s).
Reviews conducted by other internal or external monitoring programs do not take the place of the routine reviews conducted by the program.
Investigators will receive written results of the routine review and are responsible for following up with their IRB of record should any reportable events be observed. A copy of the routine review report may also be submitted to the IRB of record; however, such submission does not remove the investigator’s responsibility to submit reportable events to the IRB.
Aggregate data obtained from the routine reviews are provided to the governance structure for the FDA-Regulated Research Oversight Program to enhance the quality, efficiency, and effectiveness of FDA-regulated research on campus.
Policy Administration
Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Administrative Director FDA Regulated Research Oversight Program
Contact:
Administrative Director FDA Regulated Research Oversight Program -- Jacob Rome, rome2@wisc.edu, (608) 265-3890
