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Data Clearance Process

Research projects or investigator-initiated and scholarly quality improvement projects involving secondary data use requires clearance prior to IRB submission and approval. The Data Support Core will facilitate data clearance. Once data clearance has been given and all administrative and regulatory approvals have been confirmed, the Data Support Core will then facilitate data extraction and the data to be shared with the PI.

In data clearance process the Data Support Core confirms data availability and feasibility; this ensures the project has successful start-up once IRB is approved. Investigators are encouraged to reach out to the Data Support Core early in their protocol writing phase to identify the data elements and variables needed for their analysis.

In order to ensure that data needed to address the research question exists and is in a format that is useable without having to make multiple revisions, it is critical to develop a data tool that outlines variable to query upon. Investigators are encouraged to begin designing their data collection tool during protocol drafting. This tool can be as simple as identifying the column headers of a .CSV file used for data analysis. Designing the data collection tool begins to help translate data variables needed to the data extraction Prisma Health IS report writers may need.