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.

Internal Investigator

Each of these steps have several action steps to lead to a successful data request.

Step 1. Brainstorm, document ideas, draft data elements/variables needed for analysis.

Drafting data elements/variables may be an iterative process. Data requests require very specific detail in order to extract the correct variable that is required for the study’s data analysis. Investigators are encouraged to engage with Academic Vice Chair (AVC), mentors, and Data Support Core staff to determine exact data elements/variables needed.

Step 2. Submit Data Support Core Consultation & Clearance Intake form

When Data Clearance Intake form is submitted, the AVC of the investigator’s respective department will be notified.

Step 3. Complete AVC Scientific Review Form

The AVC Scientific Review Form is required with the IRB application, it can be done simultaneously with the Data Clearance Process. The IRB will require BOTH the AVC Scientific Reivew Form and a Data Clearance letter for review.

Step 4. Once Data Clearance has been completed and the approval letter received, you may proceed to IRB submission through the most appropriate workflow for you project / study.

IRB review is not required for projects that are Not Human Subject Research (NHSR). These projects include activities that are clearly Quality Improvement projects or studies that involve use of secondary data (retrospective data) that is totally de-identified. If you are unclear about what type of review, if any, your project requires please contact the IRB office and a pre-determination will be made of review type and provided to you prior to submitting you study/project in eIRB. If you contact the IRB, please provide an abstract or brief summary of your project and the list of data elements approved in the clearance.

Step 5. Data Request submitted to IS on behalf of investigator

Data requests will be made through IS and data will be transferred to the PI according to the protocol. All data requests will require the data clearance letter AND the IRB determination letter. If a Prisma Health internal investigator has a collaborator or study team member who will be analyzing data, additional agreement executions may be required.

HSC Academic Partners

Researchers associated to Prisma Health through the academic affiliate partners, Clemson University, Furman University, and University of South Carolina, are required to obtain data approval before submitting and IRB application.

Step 1. Brainstorm, document ideas, draft data elements/variables needed for analysis.

Drafting data elements/variables may be an iterative process. Data requests require very specific detail in order to extract the correct variable that is required for the study’s data analysis. Investigators are encouraged to engage with clinical partners, HSC Academic Research Directors, or Data Support Core staff to determine exact data elements/variables needed.

Step 2. Submit Data Support Core Consultation & Clearance Intake form

Once Data Clearance has been completed, investigators will receive an approval letter and the Data Support Core will begin to help facilitate an agreement for data use or data sharing depending on the final elements of the dataset or the elements of data that would be leaving the health system. Some academic partners will require the agreement execution prior to an IRB review or to help determine the type of IRB review. Once Data Clearance has been completed and the type of agreement has been determined for data leaving Prisma Health, the investigator can discuss with their respective institution the processes for IRB review. The Data Support Core will help initiate the agreement facilitation and execution.

Step 3. Submit IRB application at respective institution.

Note: The investigator’s respective institution may have additional forms or processes associated to study start-up.

Step 4. Data request submitted on behalf of the investigator

Once the investigator has their data approval letter, appropriate IRB determination, and registered the project in the Data Agreement Registration form, the Data Support Core staff will submit the data request through Prisma Health IS on behalf of the investigator.

Other Investigators