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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

14.5 External Problems and Safety Notices/Reports from Sponsor or Central Site



Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Current Approval Date:

November 28, 2007

Revised: June 30, 2012

 



Policy

This policy pertains to external problems (adverse events) or other materials emerging from sites other than the University of Miami or affiliated institutions within multicenter studies in which UM is engaged. 

A general principle is that investigators at all participating institutions within multicenter studies should learn of external problems (adverse events) that require prompt reporting via reports that are distributed by the sponsor, coordinating center or data safety monitoring committee.  Summary reports generated by the sponsor and/or data monitoring committee (when applicable) should be submitted for review at the time of study continuation.

External events that do not meet the criteria of unanticipated problems and have no effect on the risks to subjects participating at UM do not require reporting to the UM IRB.  External problems that are unanticipated and increase risk to subjects who are participating locally (i.e. they require a change in the protocol or consent documents) or that occur in studies in which UM is the prime awardee or coordinating center in a multicenter study should be reported to the UM IRB within 10 calendar days of their becoming known.  Changes in the protocol or consent forms that occur in response to external problems should be submitted to the UM IRB as amendments

External unanticipated problems that occur in clinical trials sponsored by cooperative groups (RTOG, COG etc) do not require reporting to the UM IRB.

A. Safety Notices, Informational Items and Reports:

Federal regulations do not require that safety notices or other informational items or reports from sponsors or a non-UM coordinating center in a multi-site study be submitted to the IRB.

UM principal investigators should maintain copies of external unanticipated problem reports, safety notices and related materials which shall be made available to the IRB upon request.



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