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Humanitarian Use Device Requirements for U-M Physicians & Investigators
Other Reportable Information or Occurrence (ORIO)
Non-Significant Risk (NSR) Medical Devices: Monitoring Requirements
Multi-Site and Performance Site applications: Reporting to IRBMED
Study-Specific Adverse Event (AE) Reporting Plans
Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting
Adverse Event Reporting
External Adverse Event (AE) Reporting
Unanticipated Problems Involving Risks to Subjects or Others
Statement of Practice: External Adverse Event Reports & Unanticipated Problems
G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

Adverse Event Reporting

Updated on:

G
Guidance
Suggested parameters and sets of instructions outlining best practices and standards for accomplishing specific duties.

External Adverse Event (AE) Reporting

Updated on: