Reporting Unanticipated Problems, Adverse Events, & Deviations

The IRB is no longer accepting (as of November 1, 2007) reports of individual AEs and SAEs unless they represent Unanticipated Problems. The requirements for reporting of AEs and SAEs have changed significantly.

 

Data Safety and Monitoring Plan

Click here for a DSMP template

 

Reporting table for Unanticipated problems, Adverse events, Serious Adverse events, and deviations

Click here for a table showing How and When to Report AEs, Unanticipated Problems, and deviations.

 

INSPIR Instructions for UPSER form

Click here for the Instructions on how to complete the UPSER form in INSPIR (to report Unanticipated Problems and summaries of Adverse Events)

  Click here for a checklist for investigators to use to assess their current compliance with AE and UP reporting requirements and plan for future reporting

  Click here for the November 2007 Clinical Research Seminar: Reporting Unanticipated Problems and Adverse Events: A Change in Policy

  Click here for a printer friendly copy of the October 2007 CR Times article that explains the changes in detail.

  Click here for the Reporting Cheatsheet

  Click here for a letter to sponsers regarding the change in our policy for reporting to the IRB AEs, and Unanticipated Problems

 

Flow Chart to determine Unanticipated problems and Adverse events

Click here for a copy of the reporting Algorithm or see below

Algorithm

Primary teaching affiliate
of BU School of Medicine