PCORI requires applicants to include a DCC with an independent scientific leadership role in study decision making about the analytical, statistical, and data management aspects of both study phases for this PFA. For potential applicants to this PFA, a Letter of Intent (LOI) may be submitted without a DCC being in place—with the proviso that invited applicants include a DCC as part of their application submission. The DCC is expected to make a substantive contribution to refining the final trial design and protocol, data collection and management, and the statistical analysis plan. During the full-scale study phase, the DCC is expected to manage data reporting, monitor study enrollment and retention, assure data quality and completeness, prepare reports for the Data Safety and Monitoring Board (DSMB), carry out all necessary statistical analyses of study findings, and ensure a high level of data integrity, security, and protection. The requirements described above provide the best guidance about acceptable DCC configurations.
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