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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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Basic Folder Information

14.4 Reporting Problems (Adverse Events) at Continuing Review



Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

April 27, 2006

Revised: June 30, 2012

 



Policy

Internal problems/adverse events that do not require prompt reporting to the IRB (per criteria defined in Section 14.3 of these policies) must be submitted as a summary of events with an assessment of risk within the continuing report. 

Although “internal” problems (adverse events) requiring prompt reporting pursuant to the criteria of 14.2 (above) should already be known to the IRB, applications for study continuance at the time of continuing review must also include a summary of those problems (adverse events).    For “external” problems (adverse events) from multi-center studies, the Principal Investigator must include with the continuing report:

  1. the most recent copy of the sponsor's analysis of the problems (if applicable)
  2. the most recent copy of the Data Safety Monitoring Board report if received by the Principal Investigator from a DSMB [NOTE – The IRB may request DSMB reports from sponsors if these are not available to the Principal Investigator].
  3. a summary of all external unanticipated problems presented in the context of the entire multi-center study, if possible.


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