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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
Statement of Practice: Remote Study Procedures
Secondary Use Research
Michigan Medicine Clinical Research Position Statement
Guidelines for Studies Conducted Through MCOHR and the Dental School
Device Study Procedure Flow
Retention of Research Data/Biospecimens

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR)

Any adverse experience occurring at any dose or level of participation that results in any of the following outcomes:

  • Results in death,
  • Is life-threatening
  • Requires inpatient hospitalization or prolongation of existing hospitalization,
  • Results in persistent or significant disability/incapacity, or
  • Is a congenital anomaly/birth defect.
  • An unexpected result of therapy or other intervention that is severe, life threatening, or fatal, corresponding to grades III, IV, or V using NCI/CTC Common Toxicity Criteria.