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 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, email or request a consultation.

The Clinical Research Toolkit provides investigators with tools and templates to help plan a clinical trial research study.

If you have questions regarding the tools, templates or other compliance-related questions in general, contact the ICTR Protocol Development team by emailing