Monitoring and Reporting Requirements

Data Safety and Monitoring Plan (no longer a separate template; instead, use the Protocol 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


Primary teaching affiliate
of BU School of Medicine