Internal problems/adverse events that do not require prompt reporting to the IRB (per criteria defined in Section 14.3 of these policies) must be submitted as a summary of events with an assessment of risk within the continuing report.
Although “internal” problems (adverse events) requiring prompt reporting pursuant to the criteria of 14.2 (above) should already be known to the IRB, applications for study continuance at the time of continuing review must also include a summary of those problems (adverse events). For “external” problems (adverse events) from multi-center studies, the Principal Investigator must include with the continuing report:
the most recent copy of the sponsor's analysis of the problems (if applicable)
the most recent copy of the Data Safety Monitoring Board report if received by the Principal Investigator from a DSMB [NOTE – The IRB may request DSMB reports from sponsors if these are not available to the Principal Investigator].
a summary of all external unanticipated problems presented in the context of the entire multi-center study, if possible.