№ files_lp_4_process_3_104422
Administrative worksheet listing categories of documents and review checklists required for Institutional Review Board evaluation of research protocols, modifications, continuing reviews, reports of new information, and humanitarian use device submissions.
Document code: HRP-301
Date: 12/16/2025
Document type: Worksheet
Subject: Institutional Review Board review materials preparation
Topic: Human research oversight and protocol review documentation
Purpose: Guidance for preparing materials for IRB review processes
Institutional body: Institutional Review Board (IRB)
Audience: IRB staff, IRB members, designated reviewers, scientific or scholarly reviewers, consultants
Related forms and documents: HRP-310, HRP-311, HRP-312, HRP-314, HRP-314a, HRP-315, HRP-316, HRP-317, HRP-318, HRP-320, HRP-321, HRP-323, HRP-333, HRP-334, HRP-410, HRP-411, HRP-412, HRP-413, HRP-414, HRP-415, HRP-416, HRP-417, HRP-418, HRP-419, HRP-441
Review stages covered: Initial review, continuing review, review of modifications, review of new information
Special review categories: Humanitarian Use Device (HUD)
Regulatory references: DHHS approved protocol and consent documentation; HIPAA authorization waiver
Content structure: Checklist of required materials for different IRB review roles and submission types
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