Research Data Security Plan (RDSP) Allows Revision

12.2 eIRB Quarterly Release Notes

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.

 An updated User Guide with step-by-step instructions is in the User Guides section of the eIRB Home page.

Study Application Page Updates  A new question has been added to page 10.1 Subject Procedures and Costs to help identify Duke Biobank studies.

 Stem Cell Registry information has been moved to the “Related Links” section of the eIRB Home page.

Display Updates  A link to the Research Data Security Plan (RDSP) has been added to the Approved study workspace.

 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).

 A link to the IRB Office web site had been added to the eIRB Home page.

 Duke Office of Clinical Research (DOCR) references have been updated.

 Expiration reminder notices have had minor updates to content and recipient lists.

Fixes/Data Updates  Email notifications for Personnel Change Requests that change the PI are correctly sent in all cases.

 Extra email notifications are no longer sent for submitted amendments.

 The error “Cannot create Continuing Review – a Continuing Review has already been opened for this study” appears only when appropriate.

 The error study teams received when electronically signing amendments has been fixed.

 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.

 Uploading a revised document is logged in the study history when a user exits without saving other changes on an application page.

 Initial review type and approval date have been updated for paper conversion studies.

 Metrics reporting is being transitioned to activity, state and transition data metrics.