№ files_lp_4_process_3_104443
Year: 2025
Institution / Department: West Virginia University (WVU), Office of Human Research Protections (OHRP)
Document Type: Standard Operating Procedure (SOP)
Purpose: Ensure awareness of updates approved by external IRBs or local investigator changes
Owner: WVU OHRP Director
Approver: WVU Vice President of Research
Responsible Staff: Reliance Coordinator, IRB Staff
Scope: External IRB submissions and local site modifications
Revisions: None
Materials Referenced: HRP-024, HRP-055, HRP-309, HRP-441, HRP-830, HRP-859
Procedures: Submission of RNI and Site Modifications, review of updates, personnel qualification checks, COI and HIPAA compliance, ancillary reviews, local event reporting, finalization of documents and letters
Compliance Requirements: IRB reliance agreements, sIRB reporting, local oversight responsibilities
Price: 8 / 10 USD
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