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Monitoring and Reporting

Data Safety and Monitoring Plan 

Corrective and Preventative Action (CAPA) Plan

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: