Research Data Security Plan (RDSP)

Research Data Security Plan (RDSP)

18 Pages · 2014 · 180 KB · English

RDSP Purpose. 2. •Institutional oversight and management of. Research Data Storage. • During an internal or external audit, can the auditors validate intended vs actual data storage? • Can we guide our researchers into more secure methods of data storage?

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Research Data Security Plan (RDSP) Reviewer Training January 6, 2014 Duke Medicine Information Security Office DATA CLASSIFICATION: PUBLIC RDSP Purpose 2 • Institutional oversight and management of Research Data Storage •During an internal or external audit, can the auditors validate intended vs actual data storage? •Can we guide our researchers into more secure methods of data storage? History of RDSP 3 •Implemented November 2011 for all new nonexempt submissions through Duke Medicine IRB •Retrospective survey in REDCap was administered by Duke Office of Clinical Research (DOCR) to all existing approved, nonexempt studies at that time RDSP review 4 •Paper review is done by CRU/Study Owning Organization Research Practice Manager or equivalent •Electronic review is done by designated IT supporting CRU/Study Owning Organization •Final approval should come after communication between paper and electronic reviewers assures that all data storage is listed and is compliant with Duke Medicine Information Security Standards and regulatory requirements “but IRB approved my study……” 5 •The human subjects must understand where data are going and authorize the arrangements which, within Duke, are accomplished via informed consent •IRB does not review the RDSP The Research Study Team and CRU/Study Owning Organization are responsible for ensuring that what is listed in RDSP is reflected in the IRB submission (consent, waivers, summary) •Communication with the study team and between reviewers is a critical aspect of the review process 01 Storage Media Types 6 Reviewer Note: If both sections are blank, this should be questioned as it is rare that a research study would not generate ANY paper or electronic data Notice that this section does not mention PHI, so unless a study has generated no paper or electronic data at all (extremely rare) then something should be checked 021 Storage of Paper or Nondigital Media 7 Reviewer Note:  Check to ensure that “yes’ or “no” is selected for each dropdown option in the section labeled "Indicate if paper or non digital media, even if the storage is temporary, contain:"  The PHI dropdown box should almost always be “Yes” If “No” is the selection, inform the PI/CRC that nearly all of the data collected for a research study at Duke Medicine is PHI Even if it only has the date of a clinical service, it qualifies as PHI Reviewer Note: SSNs require "two keys" for paper storage Temporary storage of paper SSNs (permanently redacted at earliest possible time ) may be permitted for participant payment purposes, but all other paper SSN storage requires institutional approval through Duke Medicine ISO All storage, temporary or permanent, must be listed within RDSP 022 Storage of Electronic Information 8 Reviewer Note: Temporary storage of electronic SSNs (permanently redacted at earliest possible time) may be permitted for participant payment purposes, but all other electronic SSN storage requires institutional approval through Duke Medicine ISO All storage, temporary or permanent, must be listed within RDSP 022 Storage of Electronic Information (continued) 9 Reviewer Note: This section, as of January 2014, contains two additional options for storage within: •Duke University, OIT Managed Service •Campus Department Supported IT Service If either of these options are selected, IT reviewer should email Duke Medicine Information Security Office ([email protected]) for review with subject “RDSP Pro000XXXXX” 022 Storage of Electronic Information (continued) 10 Research data stored within Duke Medicine is governed by Duke Medicine Security Standards Research data maintained outside of Duke (such as another University, sponsor, or 3 rd party contractors or subcontractors) is protected by that entity However, the human subject must understand where data are going and authorize the arrangements which, within Duke, are accomplished via informed consentIf questions arise about the propriety of the consent form, direct them to the CRU reviewer who may discuss them with IRB Office IT Staff is not responsible for reviewing consent forms, but

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