No. Establishing the DSMB is the Awardee Institution’s responsibility. The DSMB is an advisory body to the sponsor of the research project, which is typically the Awardee Institution for PCORI-funded research projects. As the funder of the research, PCORI does not convene DSMBs nor will PCORI staff serve as DSMB members. Please see the PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research for additional guidance on PCORI’s principles for structuring a DSMB.
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