1. Research Data Security Plan Overview

2. Research Data Security Plan (RDSP) The RDSP is a new section in eIRB that documents where study data is planned to be kept. The RDSP fulfills two institutional goals: Create an inventory of systems and devices where human subject research protocol data resides Create a process whereby IT Support is actively involved in helping researchers make systems and data storage choices that are in compliance with Duke Medicine Information Security Standards.

3. RSDP Process The SBRs, not the IRB, are the “process owners” of the RDSP The Principal Investigators (PIs) and Clinical Research Coordinators (CRCs) are responsible for completing the RDSP (page 12.1 in eIRB). The SBR is responsible for coordinating the review of the RDSP and its approval. -

4. The scope of the RDSP includes electronic and paper storage SBR Members are responsible for reviewing the RDSP section on paper document storage. Selected IT Staff are responsible for reviewing the RDSP sections on electronic document storage. A RDSP IT Checklist is available to help ensure that consistency in IT review throughout Duke Medicine. The IRB does not have a formal role in review of the RDSP

5. Adoption of the RSDP is Required The RDSP has been vetted with SOM Leadership. The following SOM Leadership are being routinely apprised of the RDSP rollout: Scott Gibson, Executive Vice Dean Admin Sally Kornbuth, Vice Dean for Research Wes Byerly, Assoc. Dean Research Support Services Chairs of respective areas Tina Tyson, Chief Compliance Officer Mark Phillips, OIA, IT Audit Director

6. Team Resources In May, 2011, the RDSP was successfully rolled- out in the Department of Medicine. Pat Bixby, Research Practice Manager in the DOM SBR has volunteered to help other SBR members in RSDP adoption. Bryan Watson, Director of IT in the DOM has volunteered to assist IT Staff in RDSP adoption. Rosemary Herhold, ISO for the SOM/SON is accountable for the rollout Nancy Walden, IT Analyst, IRB is coordinating documenting the workflow and updating workflow documents. Casey Schmidt, Database Analyst, IRB is responsible for programming

7. Documents to Assist your understanding User Guide http://eIRB.mc.duke.eduhttp://eIRB.mc.duke.edu RDSP Checklist https://www.iso.duke.edu/modules/iso_links/index.php?i d=17 https://www.iso.duke.edu/modules/iso_links/index.php?i d=17

8. RDSP Adoption Schedule Pediatrics SBR – July 2011 Surgery SBR – August 2011 All other SBRs – November 2011 Protocols not managed by SBRs – December 2011