Insight 3.5: Release Date March 28, Help Desk/ Service Center # (If Available) Description. Internal TFS #

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1 Insight 3.5: Release Date March 28, 2014 Internal TFS # Admin Introduction of the Research Management Applications System Help Desk/ Service Center # (If Available) Description On March 28th the Partners Research Applications group is releasing a new application which allows individual departments/divisions to self-administer the user security for both the Insight and InfoEd applications. Called Research Applications Security (RAS), this utility will be accessible to all Partners Healthcare users inside and outside of the firewall so users can request access whatever their location and the application can be accessed via links found in the Log-in pages of both Insight and InfoEd. The Research Application Security (RAS) application is a tool for users to request and manage security access for the enterprise applications owned by the PHS Research Applications Group (Insight and InfoEd). Hospital departments will be able to request and approve Organizational (Chief of Service Code) and Principal Investigator (PI) Portfolio security requests for users within their given Chief of Service (COS) Code. In addition, users can use this tool to manage the individuals who are identified as Research Contacts within the Insight application as well as those who are in Approver/Delegate roles in both the Insight and InfoEd applications. Accessing the Application: Approvers Within the RAS system, the approvers of business processes have been revised to represent the business need, as opposed to a 'one size fits all' sign off process. These are new and are documented in the Admin user manual: IRB Submission-Approver IRB Submission Alternate-Approver RBT Approver RBT Signficant Balance-Approver With this change there is no longer the concept of a "Primary Department Administrator" as the sign off person is designated for each process. 1

2 Research Contacts With the introduction of RAS, central users can no longer update departmental contact types; these will all be maintained by the departments using the RAS system. For changes to the IRB approvers there is a link in RAS to contact the IRB office to make these changes as the IRB office will continue to maintain the IRB approvers. Updates to the primary organization or primary in Insight will also update the InfoEd system so that there is more consistency between user profile data. Include the "IRB Research Office Admin" on the that is sent to the COS Oversight person when a Chief/Chair, Department Administrator or Effort Manager changes. Conflict of Interest Allow manual COI forms to replace electronic forms Changes to the COI annual forms for 2013 Annual Cycle including new questions for HMS Addition of HMS Faculty question on the annual form sign-off page Updates to the OII Dashboard and Case Review pages for IRB ecoi's and HMS events Add a search field for Event ID on the Dashboard Creation of Review Outcome Memo Changes to COI module to accommodate electronic Conflict of Interest (ecoi) for IRB. Humans - eirb Automate the investigator disclosure forms for IRB protocol submissions. Add DCR (responsible for design, conduct or reporting of research) flag and ecoi status field to Staff and Access page to facilitate electronic Conflict of Interest (ecoi) forms. Include electronic Conflict of Interest forms (ecoi) in the protocol sign-off process for any staff marked as DCR (responsible for design, conduct or reporting of research) Added ability to set Sub status through an Amendment Added Administrative Correction for IRB staff to make immediate changes to protocol Added Ancillary Committee Review Comments to Protocol Details page Added Sensitive designation to protocol as part of EPIC implementation Added requirement of CITI Certification for all study staff on submission of Intervention IR Added Financial Delegate field on Staff and Access tab as part of EPIC implementation. 2

3 35628 Added ability to add multiple Site PI's on IR submissions and amendments Added MCA ancillary board for McLean institution Updated CR enrollment validation to be more user friendly Added ability to preview published documents with stamp at final results sign off. Meetings Add ability to change Board Action until Finalize and Send (IRB) Animals - eiacuc Alll Admin Chairs that belong to a board should be able to publish the agenda and enter determinations etc. (IRB) Add Approval Period to Req Mod in Meetings, Action and Letter tab (IRB) Need to identify consultants in Agenda as consultants. (IRB) Create a PDF of Meeting Determinations for Reviewer Checklist column (IRB) Updated IACUC Agenda to print more than 2 reviewers if more than 2 are chosen Updated the standard text that appears in the' Requires Modification' and 'Deferred' Review letters Updated Initial Survey form to request which institution the study is conducted at and Protocol Header record was updated to display the institution. Created new Pharmacological Agent form which is required on new Protocols. Added validation rule to require the PI that is staffed must be from the Institution that was specified in the Initial Survey form. Created new IACUC Drug tab under the Admin > Data Management tab to allow for drugs to be added and managed for Animals Updated forms to allow new drugs to be added to the IACUC drug table as part of the submission process and to be automatically accepted once the IACUC office accepts the submission. Added legacy # to the search criteria and as a column on all of the protocol tracking pages Added ability to link to the IBC Registration from and IACUC Biological Hazardous agent form. Once linked from the form, the link will display in the IACUC protocol header. Added validation rule to prevent a Triennial Review from being submitted if it is more than 120 days before the project end date. 3

4 Updated Staff & Access page and VFA to supress the qualificaitons and experience form from appearing if it has Occupational health information included in it Removed reference to SRAC on the protocol details page Auto withdrawal of submissions was corrected to be 90 days from the notification of the submitter instead of 90 days from the meeting status date Legacy # was added to the protocol header record. Biosafety - eibc Updated Use of Animals form to allow linking to IACUC protocols if the institution is McLean or BWH Agreements Relocate "Other Support Page" tab to the Agreements module; this will no longer be available in the Effort Reporting module. The Major Goals on the OSP will be pulled from the major goals entered in the InfoEd system. Access to this page will be based on "View Salaries" access rights Agreements - Patient Care Corrections Add institution and chief code to the results of the Fund Number Lookup function (located on the top right section of Insight). Create new "Award Management" page. Add Prior Approval Required and Budget Paid to Date columns. Ability to add public notes "Department and Research Mgmt Communications" on a fund with security access based on access to fund only. Remove ARRA functionality from the Agreements module. Update the Financial Summary page to include non-po/ap encumbrances so that the page numbers tie out. 4

5 Patient Care Corrections Agreements - Residual Balance Transfers Effort Reporting Provide the ability to create a correction directly from the Patient Care Details page in Insight. The benefits of automating this include: Ability to see who the request is with at any point on a page in Insight Automatic loading of transactions when possible for the data Insight has - no manual entry of transactions for the requests made on charges that are displayed on the Patient Care Details page A way to log other types of Patient Care Correction requests using the same type of online form in Insight Ability to incorporate a Late Cost Transfer file to the PC Correction request on the same request form; today users must fill out a separate form for this through the Research Management website sent once the request is initiated and processed A way for the Research Controller to cancel the request Change the RBT process to use the RBT-Approver to sign off on RBT submissions within a department/unit and to receive communications. This replaces the need for the 'primary' Department Administrator to sign off. Change the RBT process to use the RBT Significant Balance- Approver to sign off on RBT submissions where the RBT qualifies as significant balance. This replaces the need for the Chief/Chair to sign off. InfoEd's Prior Approval Flag will be used to determine when to show the "Significant Change in Effort" flag. This will initially be used only by the central offices and will available at a future date to the departments. There was an issue fixed related to the Signficant Change in Effort flag in that the flag should only be created when the variance is greater than or equal to 25%, as related to the actual effort being that much less than the committed effort. Error message when searching in Effort Summary upon login. 5