Transcript Project Overview - Home | Duke Department of Pediatrics

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 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.
-
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
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
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
Documents to Assist your
understanding
 User Guide http://eIRB.mc.duke.edu
 RDSP Checklist
https://www.iso.duke.edu/modules/iso_links/index.php?i
d=17
RDSP Adoption Schedule
 Pediatrics SBR – July 2011
 Surgery SBR – August 2011
 All other SBRs – November 2011
 Protocols not managed by SBRs – December 2011