Guidance May 7, 2018 FDA Expanded Access Program at the University of Michigan For assistance in obtaining approval to use an Expanded Access investigational product, contact MICHR IND / IDE Investigator Assistance Program (MIAP) by emailing [email protected] The FDA Expanded Access program allows a...
Templates Mar 29, 2017 FDA Expanded Access Informed Consent Template This template should be used when creating an FDA Expanded Access informed consent document. This template is designed for use in all Expanded Access uses, which include both Compassionate Use and Emergency Use. For more information on specific...
Guidance Aug 22, 2022 Emergency Use of a Test Article in Life-Threatening Circumstances This guidance describes the circumstances regarding Emergency Use of an investigational product (drug, biologic, or device) and the procedures to be followed before or immediately following the emergency use of an investigational product. Emergency... Tags: Regulatory MICHR Investigator Initiated
Guidance Apr 17, 2012 Federal Regulations - ARCHIVED 04/23/2021: This page has been archived. IRBMED Guidance pages throughout Research A-Z link to relevant federal websites Regulations enforced by the Food and Drug Administration (FDA) 21 CFR 50 -- Protection of Human Subjects 21 CFR 56 --...
Guidance Mar 6, 2012 ARCHIVED - Accessing Medical Records UPDATE - December 2023. This page is out of date and should be considered archived. Please consult the new guidance page Secondary Use Research . When requesting records the requestor must be listed on the approved IRB, provide the IRB# and approval...
Policies Apr 28, 2023 Privacy and Confidentiality Protections for Individual-Level Data Policy The University of Michigan Medical School (UMMS) Central Biorepository (CBR) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens and... Tags: Data Use Biorepository Use
Templates Mar 13, 2018 Data Office Access Request Form Request an account for a self-serve tool through this online form through Jira. If you have issues accessing this page, please contact the Data Office at [email protected] . Tags: Data Use
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
Informational Dec 17, 2020 Guidance for Writing HUM Applications for Access to Biospecimens Stored at the CBR This page provides guidance on policies and practices related to CBR activities. It is not an exhaustive set of instructions on how you should complete your HUM application for secondary use of biospecimens. IRBMED may require more information from...
Policies Jun 18, 2020 Use and Distribution of Biospecimens and Data Policy The University of Michigan Medical School (“UMMS”) Central Biorepository (“CBR”) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens... Tags: Data Use Biorepository Use
Guidance Aug 31, 2020 Certification Preparatory to Research Review of data and/or biospecimens preparatory to research are not regulated under the Common Rule if any data obtained is not used for future research. However, if you or any member of the study team will be accessing Protected Health Information (...
Guidance Aug 10, 2020 Decedents Research involving data and/or biospecimens from decedents (deceased i ndividuals) is not regulated under the Common Rule. However, if you or any member of the study team will be accessing Protected Health Information (PHI) of the decedent(s), the...
Guidance Aug 10, 2020 Uses & Disclosures of 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 Nov 6, 2015 Certificates of Confidentiality Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on...
Guidance Feb 17, 2017 Repository Overview Data and biospecimen repositories (sometimes called registries, banks , or libraries) are used to store data, with or without biospecimens, for future research use. Federal regulations and U-M policies that protect the privacy of patients and...
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
Policies Apr 1, 2023 Establishment of Biospecimen Collections Within the Central Biorepository The UMMS Central Biorepository (CBR) is a repository of human biospecimens that serves as central storage facility, point of research access, and administrative hub for research using these biospecimens and data associated with, or derived from them... Tags: Data Use Biorepository Use
Guidance Aug 10, 2020 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 Mar 8, 2013 Electronic Records and Electronic Signatures (21 CFR Part 11) - ARCHIVED 11/8/2021: This page has been archived. UMMS Regulatory Affairs maintains documentation regarding FDA Part 11 compliance at Data Integrity and Sharing (level-2 login required). The regulations in 21 CFR Part 11 set forth the criteria under which FDA...
Templates Apr 15, 2024 Specialty Informed Consent Templates Obtaining the consent of a subject is a process that goes far beyond asking for a signature on a document. Potential participants must understand the nature of the study, the risks, discomforts, inconveniences, and potential benefits involved if... Tags: Regulatory Study Coordinator Principal Investigator Participant Management Study Teams
