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.
- Clinical Research Manual
- Before You Begin a Study
- Study Initiation
- Study Conduct
- Self-Assessment & Audit Prep
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 firstname.lastname@example.org or submit a consultation request.
- Informed Consent Checklist (PDF)
- New Clinical Research Staff Orientation & Training Checklist Template (Word Docx)
- Suggested Standard Operating Procedures
- Protocol Checklist (PDF)
- Budget Development Guidance (PDF)
- Case Report Form/Source Document Templates (20 forms)
- Subject Chart Table of Contents (PDF)
- Study Initiation Steps for Investigator-Initiated Studies (PDF)
- Regulatory Binder Guide (PDF)
- Protocol Version History Tracking (Word Doc)
- Consent Form Version History Tracking (Word Doc)
- Delegation of Duties/Signature Log Template (Word Doc)
- Protocol Activity Training Log Template (Word Doc)
- Protocol Training Tracking Log Template (Word Doc)
- Monitoring Visit Log Template (Word Doc)
- Study Contact Information Template (Word Doc)
- Investigator Agreement Guidance (PDF)
- Financial Disclosure Guidance (PDF)
- Informed Consent/HIPAA Authorization Log Template (Word Doc)
- Pre-screening Log Template (Word Doc)
- Screening and Enrollment Log Template (Word Doc)
- Corrective Action and Preventive Action (CAPA) Plan Template (Word Doc)
- Case Report Form Templates (separate page)
- FDA Site Inspection Intake Form (Word Doc)
- FDA Site Inspection Guidance (PDF)
- Self-Audit Tool: Regulatory Review Worksheet (Word Doc)
- Self-Audit Tool: Investigational Product Review Worksheet (Word Doc)
- Self-Audit Tool: Subject Record Review Worksheet (Word Doc)
- Informed Consent Review Worksheet (Word Doc)
- Staff Credential Verification Worksheet (Word Doc)