Research Administration > OHRPP > Post Approval Reporting > Post Approval Reporting
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Reporting Requirements

 

The Principal Investigator is responsible for submitting to the IRB ongoing reports of events that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research. The types of events and information that may need to be reported to the IRB include, but are not limited to:

  • Adverse Events
  • Violations, Deviations, and Incidents
  • Updated Study Safety Information

 

For a summary of post approval reporting requirements, please see the Summary Sheet of Post-Approval Reporting Requirements for Investigators.

 

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Unanticipated Problems

 

An unanticipated problem is an event or outcome that meets the following criteria: 1) unexpected; 2) related or possibly related to participation in the research; and 3) places subjects or others at a greater risk of harm than was previously known or recognized. All unanticipated problems need to be reported to the IRB via webIRB, though not all adverse events, violations, incidents or deviations are unanticipated problems.

For examples, please see the guidance document Reporting of Unanticipated Problems, Including Adverse Events as well as Protocol Violations, Deviations and Incidents and the Reporting of Updated Study Safety Information.

 

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Staff Contacts

 

Marcia Malmet, RN Assistant Director, Education and Quality Improvement

(310) 983-3150
Anthony Saldaña MIRB-1 Administrator

(310) 825-5351
Greg Ellis MIRB-2 Administrator

(310) 825-5406
Mark Mimnaugh MIRB-3 Administrator

(310) 825-4804
Gloria Varghese GCIRB Administrator

(310) 825-3969
Paul Lillig NGIRB Administrator

(310) 206-2091

 

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Page Last Updated: June 3, 2015