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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.

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Policies

Feb 3, 2020

Statement of Practice: Flexibility Initiatives

The University of Michigan's federalwide assurance with the Department of Health and Human Services (HHS) allows the IRB flexibility in its application of federal regulations to studies not federally funded or FDA-regulated. Click here for PDF...

Policies

Nov 21, 2019

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

This Office of Research policy addresses MICHR IND/IDE Investigator Assistance Program (MIAP) support and oversight for Medical School personnel and university personnel using IRBMED who serve or seek to serve as FDA-recognized Sponsors or Sponsor-...

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Guidance

Apr 10, 2018

Clinical Research Billing Guidance (CRB)

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...

Guidance

Apr 17, 2019

Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...

Guidance

Jan 3, 2008

Record Keeping Guidelines

Investigators frequently ask how long they should keep research records after a study has ended. Because different regulations apply to different types of studies there is not a simple answer to this question. Ten years is a safe default standard,...

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Statement of Practice: IRBMED Finalization of Study Documents

Statement of Practice: Flexibility Initiatives

University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services

Most Viewed

Clinical Research Billing Guidance (CRB)

Protected Health Information (PHI)

Record Keeping Guidelines

Medical School Office of Research