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Access for External Monitors to Advarra eRegulatory at Michigan Medicine
Access to Academic Research Applications for Vendors and Contractors
Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments
IRB Standard Operating Procedures
AHRQ: Mandatory Use of Data Safety and Monitoring Plans
Payment to Research Participants
Clinical Trials with No/Low Enrollment: Guide for Departments
CBR Use Proposal Form
Central Biorepository Memorandum of Understanding Regarding Use of CBR Resources
Data & Biospecimen Sharing Checklist

Human Subject

Human Subject means:

  • OHRP: “A living individual about whom an investigation conducting research obtains (1) Data through intervention or interaction with the individual or (2) identifiable private information.” 45 CFR 46.102 (f)
  • FDA: “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” 21 CFR 50.3 (g) and 21 CFR 56.102 (e)