University of Wisconsin–Madison

Clinical Research Toolkit

Through collaboration with multiple research disciplines, the documents below were created to assist investigators and research teams at various timepoints throughout a clinical research study. They are geared towards investigator-initiated, or investigator-sponsor type research studies where the investigator has more responsibilities, and represent the local vision for the conduct of clinical research at the UW-Madison.

The templates and tools are to be used as guidance; research teams are not required to follow the documents exactly. Some of the documents or tools are not applicable to all studies. Also, the nature of some research may warrant the development or use of additional tools related to specific research specialties or subject populations. Additionally, some sponsors, CROs, or federal agencies may require that investigators keep additional documents that are not specifically referenced in this guidance.

If you have questions regarding the tools, or other compliance related questions in general, contact the ICTR Study Monitoring Service team by emailing compliance@lists.wisc.edu or requesting a Study Monitoring Service consultation.

The ICTR Clinical Research Manual: A Guide to Conducting Clinical Research at UW Health serves not only as the course manual to accompany the Basics of Conducting Clinical Research at UW Health online training offered by UW ICTR, but also a resource that can be referenced at any time.

Each chapter of the manual corresponds to a lesson in the online course, with the final chapter describing the various resources and services available to researchers. In addition, the manual includes references to several of the tools and templates available in the Clinical Research Toolkit.

If you have questions regarding the manual, tools, templates or other compliance related questions in general, contact the ICTR Study Monitoring Service team by emailing compliance@lists.wisc.edu or submit a Study Monitoring Service consultation request.

ICTR Clinical Research Manual: A Guide to Conducting Clinical Research within UW Health (PDF)