Research Data Security Plan Overview

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.

RSDP ProcessThe SBRs, not the IRB, are the “process

owners” of the RDSPThe 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.

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The scope of the RDSP includes electronic and paper storageSBR 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

Adoption of the RSDP is RequiredThe RDSP has been vetted with SOM

Leadership.The following SOM Leadership are being

routinely apprised of the RDSP rollout:Scott Gibson, Executive Vice Dean AdminSally Kornbuth, Vice Dean for ResearchWes Byerly, Assoc. Dean Research Support

ServicesChairs of respective areasTina Tyson, Chief Compliance OfficerMark Phillips, OIA, IT Audit Director

Team ResourcesIn 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

Documents to Assist your understandingUser Guide http://eIRB.mc.duke.eduRDSP Checklist

https://www.iso.duke.edu/modules/iso_links/index.php?id=17

RDSP Adoption SchedulePediatrics SBR – July 2011Surgery SBR – August 2011All other SBRs – November 2011Protocols not managed by SBRs –

December 2011