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