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Policies

Jul 10, 2020

Statement of Practice: eResearch Cross-Reference Table

IRBMED has developed the eResearch Cross-Reference Table and Guide to guide study team members, IRB staff, and IRB board members in achieving complete and consistent resolution of all IRB review contingencies. Click here for PDF version.

Tags: IRBMED Statement of Practice

Policies

Feb 12, 2020

Statement of Practice: IRBMED Finalization of Study Documents

This document replaces: ‘ Approval Dates on Consent Documents and Recruitment Materials ’ Statement of Practice. Click here for PDF version.

Tags: IRBMED Statement of Practice

Policies

Mar 2, 2022

Statement of Practice: HIPAA and U-M study team members outside Michigan Medicine in eResearch applications

Consult guidance from Michigan Medicine Corporate Compliance Office (level-2 login or VPN required) and IRBMED for general definitions (PHI, HIPAA, Covered Entity, etc.) and concepts. The vast majority of studies subject to IRBMED oversight involve...

Tags: Study Coordinator Principal Investigator Study Teams IRBMED Statement of Practice

Policies

Oct 15, 2021

Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control

To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices...

Tags: Study Coordinator Study Teams IRBMED Statement of Practice