Forms

Site Committee

Required Documents

Amendment Review Form (updated 08/18/2020)
(not required for every submission – see Amendment Submission Policy)
Chair/Co-Chair Summary of Review Form (updated 07/02/2021)
Concept Review Form (updated 07/02/20)
Deferred for Revision Response Review Form (updated 12/03/18)
Expanded Access Site Committee Chair/Co-Chair Approval (updated 08-12-2019)
Expedited Reviewer's Comments Form (updated 07/02/2021)
Feasibility/Prioritization Site Committee Review Form (NEW 08/26/2021)
Membership Roster (from SC Memb. Policy 12/12/2022)
Quarterly Report (updated 9/12/18)
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)
Summary of Changes Template (updated 10/02/2015)
Supplemental Site Committee Review Form (updated 05/01/19)

Optional Documents

International Study Review Guidance Document (created 04/26/2021)
Leadership Terms Calculation Tool (created 08/28/2023)
Numerical Ranking (Resource Prioritization) List Sample
Safety Review Forms Sample
Site Committee Checklist (updated 12/17/15)

Protocol Review and Monitoring Committee

Applicant Submission Forms

Amendment Submissions

Amendment Review Form (updated 08/18/2020)
(not required for every submission – see Amendment Submission Policy)
Protocol Facepage Sample
Summary of Changes Template (Updated 10/02/2015)

Other

Site Committees Contact Information

Member Review Forms

Biostatistician Reviewer's Comments Form (updated 12/17/2014)
Primary Reviewer's Comments Form (updated 12/23/2015)
Secondary Reviewer's Comments Form (updated 12/17/2014)

Study Conduct

Protocol Templates

Behavioral Research Protocol Template (updated 6/9/2021)
Guidelines for Studies of Host Determinants of Drug Response and Toxicity (New as of Feb 2021)
Phase I Protocol Template (updated 03/15/2022)
Phase II Protocol Template (updated 07/26/2021)

Expanded Access

Expanded Access Site Committee Chair/Co-Chair Approval (updated 08-12-2019)