Reporting and Reviewing Unanticipated Problems and Adverse Events

1. Reporting and Reviewing Unanticipated Problems and Adverse Events HHS Regulations at 45 CFR part 46 Freda Yoder Division of Education & Development Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Case Western Reserve University June 19, 2006

2. Outline Background OHRP Draft Guidance Document Work in progress Relevant regulation Unanticipated problems vs. adverse events Procedures for handling reports of adverse events/unanticipated problems Reporting incidents to OHRP Resources

3. Human Subject Protections

Reporting and Reviewing Unanticipated Problems and Adverse Events

Reporting and Reviewing Unanticipated Problems and Adverse Events

Presentation Transcript

Adverse Events and Serious Adverse Events

Reporting Adverse Events What, When, How?

Reporting Adverse Events to the IRB

New IRB Policies Reporting Unanticipated Problems & Adverse Events Data & Safety Monitoring

HHS Reporting Requirements and Adverse Events

Reporting Adverse Events in Research to ORO

Complications, Adverse Events and comorbidities

Unanticipated problems

Unanticipated Problems

Smallpox Vaccine Safety and Reporting Adverse Events

SERIOUS ADVERSE EVENTS REPORTING

Understanding Unanticipated Problems (UPs)

Adverse Events, Unanticipated Problems, Protocol Deviations & other Safety Information

Reporting Adverse Events What, When, How?

Adverse Events and Serious Adverse Events

Reporting Adverse Events and Unanticipated Problems to the UAB IRB

Reporting Unanticipated Problems Involving Risk to Subjects or Others and Adverse Events

Adverse Events

Smallpox Vaccine Safety and Reporting Adverse Events

Capturing and Reporting Adverse Events in Clinical Research

5. National and international reporting of adverse events: mechanisms, routes and resources

Reporting and Reviewing Unanticipated Problems and Adverse Events