Forms

Site Committee

Required Documents

• Concept Review Form (updated 07/02/20)
• 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

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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 (updated 07/31/2020)
  (not required for every submission – see Amendment Submission Policy)

Other

• Site Committees Contact Information

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)

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Study Conduct

• DOA Policy Study Specific DOA Log template
• DOA Policy Study Personnel Master Signature Page
• DOA Policy Note to file

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Protocol Templates

• Phase I Protocol Template
• Phase II Protocol Template

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Expanded Access

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