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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
Statement of Practice: Remote Study Procedures
Secondary Use Research
Michigan Medicine Clinical Research Position Statement

Protocol Exception

Term used by FDA and some sponsors to refer to a departure from the protocol that receives approval from the IRB before implementation (a one-time exception as distinguished from an amendment to the protocol). Approval requests for a protocol exception should be submitted using the ORIO submission in eResearch. Investigator should specify the extent of the exception (e.g., one-time only for patient X and note if data will be included in the study analysis). If the exception is to become a permanent change, an Amendment submission in eResearch needs to be submitted.