The University of Wisconsin School of Medicine and Public Health often conducts clinical trials. Clinical trials are a subset of human subjects research and are commonly sponsored by industry.
It is important to differentiate clinical trials from other human subjects research, since different policies relating to the acceptability of certain contractual terms are applicable.
Clinical trials are defined as falling into one of the following categories:
- Any study that is intended for submission to a regulatory agency in support of registration of an intervention
- A prospective biomedical or behavioral research study in which the safety, pharmacokinetics, or therapeutic effect of an intervention is being evaluated
- A prospective biomedical or behavioral research study in which a diagnostic procedure or test is being evaluated for its effectiveness in diagnosing a disease state or condition
One attribute of a clinical trial is that it follows a prescribed protocol with specified endpoints. It does not involve an iterative, discovery-oriented process of first evaluating, then improving or modifying the intervention or diagnostic being tested, then re-evaluating, etc., and the associated open-ended experimental design.
A second attribute of a clinical trial is that it involves patient care activities or interactions with healthy volunteers as a major component of the work, or that it is an activity supporting a clinical trial, such as biostatistical analysis.
Procedures for Establishing Clinical Trials Agreements
All clinical trials must be processed through the University of Wisconsin School of Medicine and Public Health’s Office of Clinical Trials. Clinical trial agreements received from sponsors can be sent to the UW-Madison office of Research and Sponsored Programs for negotiation, using a WISPER approval, without initial routing through the School of Medicine and Public Health dean’s office.
When the agreement and budget are finalized, the WISPER record is then routed to the UW School of Medicine and Public Health division address. Note: All new clinical trials must attach the OnCore ancillary report to the WISPER record ensuring registration and the appropriate clinical trial expenses. For questions on OnCore contact Tracy Ohrt, (608) 262-7505.