What data safety and monitoring updates should be provided to PCORI?

In accordance with the reporting requirements described PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research, awardee institutions must include a summary of any data safety and monitoring issues in their interim progress reports to PCORI.  Notwithstanding those reporting requirements, the awardee institutions must fulfill all reporting obligations related to any serious unanticipated problems related to the research study that are required by the sponsor, DSMB, IRB, or FDA.  As the funder of the research study, PCORI expects to be informed of serious unanticipated problems RELATED TO THE RESEARCH PROJECT on an accelerated timetable -- those must be reported to PCORI promptly and no later than 10 days after the sponsor and appropriate oversight bodies have been notified.