Monitoring and Reporting

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.
• Note that if a different IRB is the IRB of record:
  • The reporting requirements of the IRB of record must be followed; AND
  • Internal Study Personnel Changes and local Unanticipated Problems must also be reported to the BMC-BU Medical Campus IRB

Flow Chart to determine Unanticipated Problems and Adverse Events

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