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.
- 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 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)
- Informed Consent Checklist (PDF)
- New Clinical Research Staff Orientation & Training Checklist Template (Word Doc)
- Suggested Standard Operating Procedures (SOPs) (PDF)
- 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 Training 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)
- Research Sample Tracking Log Template (Word Doc)
- Device Accountability Log (per protocol) (Word Doc)
- Drug Accountability Log (per protocol) (Word Doc)
- Serious Adverse Event Tracking Log (per protocol) (Word Doc)
- Protocol Deviation Log (per protocol) (Word Doc)
- Note to File Template (Word Doc)
- Corrective Action and Preventive Action (CAPA) Plan Template (Word Doc)
- FDA Site Inspection Intake Form (Word Doc)
- FDA Site Inspection Guidance (Word Doc)
- Self-Audit Tool: Regulatory Review Worksheet (Word Doc)
- Self-Audit Tool: Investigational Product Review Worksheet (Word Doc)
- Self-Audit Tool: Subject File/Chart Review Worksheet (Word Doc)
- Informed Consent Review Worksheet (Word Doc)
- Staff Credential Verification Worksheet (Word Doc)