Site Committee
Required Documents
- Concept Review Form (updated 07/02/20)
- Primary Reviewer's Comments Form (updated 07/02/2021)
- Secondary Reviewer's Comments Form (updated 07/02/2021)
- Statistical Reviewer's Comments Form (updated 11/13/18)
- Expedited Reviewer's Comments Form (updated 07/02/2021)
- Chair/Co-Chair Summary of Review Form (updated 07/02/2021)
- Deferred for Revision Response Review Form (updated 12/03/18)
- Feasibility/Prioritization Site Committee Review Form (NEW 08/26/2021)
- Supplemental Site Committee Review Form (updated 05/01/19)
- Expanded Access Site Committee Chair/Co-Chair Approval (see Expanded Access section below)
- Review Activity Quarterly Report (updated 9/12/18)
Optional Documents
- Site Committee Checklist (updated 12/17/15)
- Sample Numerical Ranking (Resource Prioritization) List
- Sample Safety Review Forms
- International Study Review Guidance Document (created 04/26/2021)
Protocol Review and Monitoring Committee
Applicant Submission Forms
Amendment Submissions
- Summary of Changes Template (Updated 10/02/2015)
- Sample Protocol Facepage
- Site Committee Protocol Amendment Review Form (updated 08/18/2020)
(not required for every submission – see Amendment Submission Policy)
Other
Member Review Forms
- Primary Reviewer's Comments Form (Updated 12/23/2015)
- Secondary Reviewer's Comments Form (Updated 12/17/2014)
- Biostatistician Reviewer's Comments Form (Updated 12/17/2014)
Study Conduct
- DOA Policy Study Specific DOA Log template
- DOA Policy Study Personnel Master Signature Page
- DOA Policy Note to file
Protocol Templates
- Phase I Protocol Template (Updated 03/15/2022)
- Phase II Protocol Template (Updated 07/26/2021)
- Behavioral Research Protocol Template (Updated 6/9/2021)
- Guidelines for Studies of Host Determinants of Drug Response and Toxicity (New as of Feb 2021)