New IRB Policies Reporting Unanticipated Problems & Adverse Events Data & Safety Monitoring Susan Burner Bankowski, M.S., J.D. Chair, OHSU IRB.
EMORY INSTITUTIONAL REVIEW BOARD VERSION 8-1-13 Unanticipated Problems, Protocol Deviations and Non-Compliance.
Capturing and Reporting Adverse Events in Clinical Research
Adverse Events
Unanticipated Problems, Protocol Deviations and Non-Compliance
Unanticipated Problems Potentially Involving Risks to Subjects or Others