Monitoring and Reporting Requirements

Data Safety and Monitoring Plan

Click here for a DSMP template

 

Corrective and Preventative Action (CAPA) Plan

Click here for a CAPA plan template

 

Reporting table for Unanticipated Problems, Adverse Events, Serious Adverse Events, and Deviations

Click here for a table showing required reporting to the IRB after initial approval.

 

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