The transfer of data to and from the Enterprise for research purposes is an important aspect of translational science in an Academic Learning Health System. Research Administration and Information Technology recognized that an additional resource was needed to provide research teams with best practice and cost information early in the study design process to avoid last-minute surprises that could impede research.
What is R-EDAR?
The team was recently formed to assist investigators when preparing to receive or distribute certain types of data requiring additional protection (e.g., Protected Health Information; International Data; Claims data, etc.). The R-EDAR team will not approve or disapprove the study. Instead, the R-EDAR team will review to verify that appropriate data governance, security and privacy controls are in place. Once that is satisfied, the R-EDAR team will refer the research protocol to the IRB for study review (if required).
The following services are provided:
- Planning for transfer and storage of external data, any associated costs, and IT resource needs so that these factors can be included in grant budgets or contract negotiation.
- Assists in routing to any other required groups for approval (e.g., for claims data use) to facilitate faster processing.
- Works with investigators as the study evolves to ensure that proposed changes to data categories, transfer or storage methods meet current regulatory and Enterprise requirements.
Who is involved?
The R-EDAR team is comprised of representatives from Information Technology, Enterprise Privacy, Office of Sponsored Programs, Office of Informatics, Office of Regulatory Affairs, and research faculty representatives. With this expertise we are positioned to provide guidance on best practices, tailored to the needs of a particular study in an efficient and timely way.
How does it work?
Study teams can access R-EDAR team members in several ways, depending on their needs.
- For those planning a project that may require special transfer, storage, or tracking processes, use of novel technologies, etc., R-EDAR can be accessed through Service Now for consultation on appropriate processes, cost estimates, and how to describe the security measures for grant and contract language.
- For those with plans already in place who are submitting grant applications involving the receipt or distribution of data outside the Enterprise, R-EDAR will automatically receive the application for review as a part of the standard procedures. This will help ensure that any adjustments to processes can be made before proposals are submitted and avoids complications for study teams at the time of an award.
- The IRB submission process will automatically route applications that involve certain types of data transfer or receipt to R-EDAR as an ancillary review.
R-EDAR meets formally once per week and can assist study teams on an Ad-Hoc basis as needed.
To request a consultation with the R-EDAR team please email lrodgers@wakehealth.edu. |
Contact for Questions |
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Joe Andrews |
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Pat Corn pcorn@wakehealth.edu Enterprise Privacy Office |
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Larisa Rodgers lrodgers@wakehealth.edu CTSI Office of Informatics |