Policies University of Michigan Medical School Policy on Requirement to Use MICHR MIAP Services Nov 21, 2019 1:30 pm Copy Generated on: October 9, 2024, 12:20 am Login to Bookmark Print Share 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-Investigators. I. Purpose The purpose of this policy is to ensure that any University of Michigan Medical School (UMMS) personnel and University of Michigan personnel using the Institutional Review Board of the UMMS (IRBMED) who serve or are seeking to serve as a United States Food and Drug Administration (FDA)-recognized Sponsor or Sponsor-Investigator (S-I; i.e., IND or IDE holder) receive expert support and oversight from the Michigan Institute for Clinical and Health Research (MICHR) Investigational New Drug / Investigational Device Exemption (IND/IDE) Investigator Assistance Program (MIAP) in order to reduce noncompliance risk. II. Policy It is the policy of the UMMS to require that any university personnel holding or seeking to hold an FDA IND or Significant Risk Device IDE in conjunction with his or her university appointment receive oversight and support from the MICHR MIAP. III. Procedures Prior to initiating an IND or IDE application to the FDA, personnel must notify MICHR MIAP to arrange for support and oversight (fees may apply). MICHR MIAP support and oversight includes: training on Sponsor and S-I requirements; document preparation and retention, application review, and IND/IDE maintenance reports; and monitoring by the MICHR Study Monitoring Unit (for non-oncology studies), or other professional monitoring unit (at study expense) as deemed suitable by MIAP. Abbreviated IDE Sponsors or Sponsor-Investigators are exempt from this policy. The UMMS Executive Vice Dean for Research and Associate Dean for Regulatory Affairs, or their delegates, will jointly consider other exceptions to this requirement on a case-by-case basis. Failure to adhere to this policy may result in restriction to conduct certain or all FDA-regulated research. IV. References UM Human Research Protection Program (HRPP) Operations Manual (OM) Part 8 section VII.B. FDA regulations at 21 CFR 312.50-59 and 21 CFR 812.40-47 V. History and Approval This policy is effective January 1, 2020. Original policy approval date: November 21, 2019 Policy revisions: updated by Ann Curtis, per Pat Ward, May 3, 2021. Approver: Steven L. Kunkel, PhD, Executive Vice Dean for Research Tags: MICHR Units: Institutional Review Boards (IRBMED) Topic: Clinical Trial FDA (Drugs, Devices & Biologics) Questions? MICHR IND/IDE Investigator Assistance Program (MIAP) [email protected] or 734-998-7598 Related Documents FDA Expanded Access Program at the University of MichiganEmergency Use of a Test Article in Life-Threatening CircumstancesFDA Expanded Access Informed Consent TemplateInvestigator Responsibilities