Research Data Security Plan (RDSP) Allows Revision

Research Data Security Plan (RDSP) Allows Revision

<p>12.2 eIRB Quarterly Release Notes</p><p>Research Data Security Plan (RDSP) Allows Revision  Study teams can now use the eIRB to submit revisions to previously approved security plans. Revisions follow the same review and approval process as the initial RDSP. </p><p> An updated User Guide with step-by-step instructions is in the User Guides section of the eIRB Home page.</p><p>Study Application Page Updates  A new question has been added to page 10.1 Subject Procedures and Costs to help identify Duke Biobank studies.</p><p> Stem Cell Registry information has been moved to the “Related Links” section of the eIRB Home page.</p><p>Display Updates  A link to the Research Data Security Plan (RDSP) has been added to the Approved study workspace.</p><p> All studies share the same study workspaces. An icon has been added to the Codes: section of the study workspaces to identify paper conversion studies (studies in the eIRB that were originally approved on paper).</p><p> A link to the IRB Office web site had been added to the eIRB Home page.</p><p> Duke Office of Clinical Research (DOCR) references have been updated.</p><p> Expiration reminder notices have had minor updates to content and recipient lists.</p><p>Fixes/Data Updates  Email notifications for Personnel Change Requests that change the PI are correctly sent in all cases.</p><p> Extra email notifications are no longer sent for submitted amendments.</p><p> The error “Cannot create Continuing Review – a Continuing Review has already been opened for this study” appears only when appropriate.</p><p> The error study teams received when electronically signing amendments has been fixed.</p><p> Full committee review workflow from changes requested to review complete has been fixed.  Approve consent forms activity is not allowed when an amendment is in progress in all cases.</p><p> Uploading a revised document is logged in the study history when a user exits without saving other changes on an application page. </p><p> Initial review type and approval date have been updated for paper conversion studies.</p><p> Metrics reporting is being transitioned to activity, state and transition data metrics.</p>

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