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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

Adverse Drug Reaction (ADR)

All harmful and unintended responses to a research use of a medicinal product (drug) related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between the drug and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.