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Beginning with Cycle 1 2019, the PCORI Contract for Funded Research includes express obligations to comply with the terms of this Policy. Awardees funded through the Pragmatic Clinical Studies (PCS; recently subsumed into the Broad Pragmatic Studies PFA), Targeted Funding Announcement, PCORnet research, and the Phased Large Awards for Comparative Effective Research (PLACER) mechanisms will be required to adhere to Policy as outlined below:
- Pragmatic Clinical Studies or Targeted Funding Award: The Policy calls for deposition of the Full Data Package (or required data elements, as applicable) in a PCORI-designated repository. The Full Data Package is discussed in more detail below in the “Data deposition and availability of data” section of this document.
- Note: The Pragmatic Clinical Studies funding mechanism was subsumed into the Broad Pragmatic Studies (BPS) PFA in Cycle 1 2022. As such, the data sharing requirements for BPS awardees have been updated and are described below.
- Broad Pragmatic Studies Funding Award:
- Cycle 1 2019 – Cycle 3 2021 (Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Communication and Dissemination Research; and Improving Healthcare Systems): The Policy calls for maintenance of the Full Data Package for seven (7) years following acceptance by PCORI of the Final Research Report. In that time, PCORI may provide funds for the deposition of the Full Data Package in the PCORI-designated repository in circumstances where PCORI requests such deposition (e.g., due to PCORI estimate of high importance of research project findings or external research request).
- Cycle 1 2022 and after: Awardees with a research project award greater than $5 million, and up to $10 million, in direct costs (category 2) and are expected to deposit data in accordance with PCORI’s Policy for Data Management and Data Sharing. Please refer to the standing BPS PFA for more details.
- PCORnet Funding Award: The Policy calls for deposition of specified data elements, including, but not limited, to the Full Protocol for specific research project; description of the PCORnet Common Data Model tables, including ancillary or ad hoc tables (if applicable); all code used to query PCORnet data; aggregate level dataset(s); aggregate results of any new or research project-specific data quality investigations; and results from research project-specific analytical queries.
- Phased Large Awards for Comparative Effective Research PLACER: PLACER awardees will only be required to adhere to the Policy once it is clear the study will be proceeding to full-scale conduct. Following successful completion of the full-scale phase, the Policy calls for deposition of the Full Data Package.
A full data management and data sharing plan for the proposed research project will not be evaluated at the application stage; however, such a plan will be required and must be submitted to PCORI as part of the Full Protocol if an award is made. As described in the Policy, the plan must adhere to the PCORI Methodology Standards for Data Integrity and Rigorous Analyses, specifically Standard IR-7.