Forms
- Clinical Research
- Forms
Site Committee
Required Documents
- Concept Review Form (updated 11/13/18)
- Primary Reviewer's Comments Form (updated 11/13/18)
- Secondary Reviewer's Comments Form (updated 11/13/18)
- Statistical Reviewer's Comments Form (updated 11/13/18)
- Expedited Reviewer's Comments Form (updated 11/13/18)
- Chair/Co-Chair Summary of Review Form (updated 8/19/19)
- Deferred for Revision Response Review Form (updated 12/03/18)
- 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
Protocol Review Committee
Applicant Submission Forms
Amendment Submissions
- Summary of Changes Template (Updated 10/02/2015)
- Sample Protocol Facepage
-
Site Committee Protocol Amendment Review Form (NEW)
(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