Since 2015, PCORI has established in its funding announcements and in its research contracts that Awardees must develop a data management and data sharing plan and be prepared to share research project data. The Policy now adds additional specificity and clarification to that general requirement.
If you are an Awardee with a Pragmatic Clinical Studies or Targeted research award funded through a funding announcement before Cycle 3 2018, 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.
If you are an Awardee with a PCORnet research award funded through a funding announcement before Cycle 3 2018, 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.
If you are an Awardee with a Broad research award (Assessment of Options, Improving Healthcare Systems, Addressing Disparities, Communication and Dissemination Research, Improving Methods) funded through a funding announcement before Cycle 3 2018, the Policy calls for maintenance of the Full Data Package for seven (7) years. 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).