This toolkit of materials contains templates, sample forms and information materials to assist clinical investigators in the development and conduct of high-quality clinical research studies. All files on this page link directly to a Word file maintained on the NIH website unless otherwise noted. Need assistance? Contact Regulatory Specialist Sheila Austin, 352-273-8702.
Regulatory Binder Checklist (NIH)
The following 12 items can be found in this checklist from the National Institutes of Health, which downloads as a Word document.
- Delegation of Responsibilities Log
- Documenting the Consent Process
- Financial Disclosure Form (see page 40)
- Investigational Product Accountability Drug – Stock Record Log
- Investigational Product Accountability Device – Stock and Subject Log (Word document downloaded from NIH May 2019 and maintained on this site)
- Monitoring Visit Log
- Protocol Deviation Tracking Log
- Regulatory Document Log – List of all documents submitted to the FDA
- Site Screening and Enrollment Log
- Specimen Tracking Log
- Subject Code Log – NIH (Word document downloaded from NIH May 2019 and maintained on this site)
- Training Log
Subject File Tools (NIH)
- Informed Consent Process Checklist Subject
- Investigational Product Accountability Drug – Subject Record Log
Miscellaneous File Tools
- Daily Temperature Log for Refrigerator and Freezer (FLDOH)
- Concomitant Medications and Therapies List (UNC)
- Good Clinical Practice Investigator Checklist (UNC)
- Study Closeout Checklist (UNC)
Quality Management Tools (NIH)
- QM-Clinical Quality Management Plan Template
- QM-Essential Documents Review Tool
- QM-Participant Data Review Tool
- QM-Quarterly Review Tool
- QM-Annual Review Tool
UF Institutional Review Board Tools
- Adverse Unanticipated Events Table (UF IRB)
- Deviation Tracking Log (UF IRB)
- Informed Consent Process Checklist (UF IRB)
- Note to File Template (UF IRB)
SOPs
- Recommended List of Site SOPs (Word document downloaded from ACRP in May 2019 and maintained on this site)
- SOP Writing for Clinical Research (PDF document downloaded from the University of Washington in May 2019 and maintained on this site)