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Version 3.9 Information | August 12, 2017

  • General Site Updates
    • Platform updated to latest Click version
      • Icons with alt text will now display upon click, when hovering is unavailable
    • Committee
      • Updated the following activities so it is only available to administrators specific to that committee (instead of being available to all members): Add New Meeting, Edit Members, Edit Minutes Distribution List, Edit Committee Info
      • Granted access for IBC and RSC to view Adverse Events
    • Meeting
      • "Snapshot Minutes" now only available to system administrators

 

  • IRB Changes
    • Conflict of Interest Questions removed excepting the staff table where possible conflicts are selected from financial interests submitted in diSClose. Affects the Co-Investigator's Agree to Participate activity, Page 39 of the application, and the Submit Application activity. Also affects the display of COI information on Continuing Review pages and the Review of Continuing Review pages
    • Form Changes
      • Page 36: HIPAA forms are no longer asked to be uploaded unless a modification has been made to the approved forms from the Office of Compliance
      • Page 39: COI questions removed other than the study staff table
    • The Confirm Minutes step in workflow has been made optional for USC, and remains the same for CHLA IRB.
    • Pre-Review functionality extended to Amendments
    • Designated Reviewers can now see the staff review on their review page
    • Can now unsuspend a study at Continuing Review
    • Amendment Q. 5.3 - SNIF option removed
    • IRBAs can now relate an Amendment to a Continuing Review
    • Consent forms are now available even if a study is suspended. Instead of making them unavailable, a warning is provided
    • DHS email reworked; new monthly status report added
    • HUD Continuing Reviews: target accrual calculations removed, warnings eliminated
    • Guest list bug preventing study staff who were also on the guest list from editing Amendments or Continuing Reviews has been fixed.
    • Various miscellaneous bug fixes and enhancements

 

  • IACUC Changes
    • Form Changes
      • Modified the IACUC PI&Staff homepage to accommodate IBC BUAs and RSC RUAs. Re-organized tabs and streamlined existing sections and added conditional display to only show sections that have results in the My Inbox section
      • Protocol Page 1 now asks for Accounting Contact in 1.6
      • On the Submit Application activity, the PI now needs to verify/update their Emergency Contact Number and Assigned Authorized Submitters
      • An "Adjust Authorized Submitters" activity has been added to allow the PI to change authorized submitters at any time
      • Authorized Submitters can submit changes, renewals and amendments anytime after the initial submission by the PI. They are also authorized to create new renewals and amendments.
      • The History Log now shows "Changes Submitted" when the "Submit Changes" activity is run instead of "Submit Changes"
      • Updated OHS reminder, expired, and non-compliance email templates to reflect new webpages for the program info and form
      • Protocols flagged for monitoring will now have reminders go to the PI and the Vet every 60 days
      • Various miscellaneous bug fixes and enhancements
    • Staff
      • Added IACUC Training courses "Intro to Amphibians" and "Intro to Swine"
      • Added Two Reports: Expired BUAs and BUAs expiring in 30 days or less
      • IACUC Specialist homepage: Removed Unassigned protocols and removed ownerships as a requirement for it to be displayed in a particular category. Added conditional display to only show sections that have results.
      • DMR Reply to Stipulation email notification is re-enabled
      • NCR will now CC the Vice President of Research once it's finalized
      • Messages can now be sent between IACUC Members/DAR/Vets
    • Committee
      • "Return for Reviewer Re-Assignment" activity now only appears to members that are assigned the protocol to review and not to all members
      • Added 3 Reports for IACUC Chair: 1) Approved protocols with expired BUAs 2) Approved protocols with IBC with expired BUAs 3) Approved protocols with IBC but no related BUA

 

  • IBC Changes
    • Form Changes
      • Page 1 is reorganized and renumbered; 1.6.2. wording has been updated. Section 1.3. (Project and Funding Info) has been moved to page 15; Section 1.4 (Shipping and Transport) has been moved to Page 14
        • 1.2.1 Recombinant or Synthetic Nucleic Acids becomes 1.2
          • 1.2.1.1. Are any rDNA materials used in human subjects becomes 1.2.1.
          • 1.2.1.2. Is this a clinical trial becomes 1.2.2.
        • 1.2.2. Biologically Derived Toxins, including Select Agents becomes 1.3.
        • 1.2.3. Potentially Infectious Microorganisms become 1.4.
        • 1.2.4. Potential Dual Use Research of Concern 1.5.
          • 1.2.4.1. Does this research enhance the harmful consequences of the agent or toxin becomes 1.5.1.
          • 1.2.4.2. Does your research disrupt immunity becomes 1.5.2.
          • 1.2.4.3. Does your research confer to the agent or toxin resistance becomes 1.5.3.
          • 1.2.4.4. Does your research increase the stability, transmissibility or the ability to disseminate the agent or toxin becomes 1.5.4.
          • 1.2.4.5. Does your research alter the host range or tropism of the agent or toxin becomes 1.5.5.
          • 1.2.4.6. Does your research enhance the susceptibility of a host population to the agent or toxin becomes 1.5.6.
          • 1.2.4.7. Does your research generate or reconstitute an eradicated or extinct agent or toxin listed in this list becomes 1.5.7.
        • 1.2.5. Human cell lines, blood, tissue, or other human/nonhuman primate materials becomes 1.6.
        • 1.2.6. Animal cell lines, blood, tissue, or other materials becomes 1.7.
        • 1.2.7. Working with Live Animals becomes 1.8.
          • 1.2.7.1. Are any rDNA materials or recombinant synthetic nucleic acids or recombinant organisms administered to live animals becomes 1.8.1.
          • 1.2.7.2. Will recombinant synthetic nucleic acids be used for the production of transgenic becomes 1.8.2.
          • 1.2.7.3. Does your project involve breeding/purchase/transfer of transgenic animals becomes 1.8.3.
        • 1.2.8. Human Fetal Tissue becomes 1.9.
        • 1.5.1. Does your research involve any biohazardous chemicals found on this list becomes 1.10.
        • 1.5.2. Does your research involve any biohazardous chemicals to live animals becomes 1.11.
        • 1.6.1. Does your research involve radioactive materials, radiation producing devices, or X-ray producing devices becomes 1.12.
          • 1.6.1.1. List of Isotopes becomes 1.12.1.
          • 1.6.1.2. Radiation Safety Permit Number becomes 1.12.2.
        • 1.6.2. Does any projects listed in 1.3 involve the exposure of live animals to radiation becomes 1.13.
          • 1.6.2.1. Has RSC approval been obtained? Becomes 1.13.1.
      • Biohazard and Blood Symbol icons are now switched
      • When creating a Renewal, the first page describing changes is now removed
      • IBC Section – Tabs are re-labeled and renamed to be more accurate as to what it contains. "Archived" has been updated to "Archived/Expired" and a new tab named "Withdrawn/Approval Withheld" has been added.
      • Updated external reference hyperlinks in formset Page 1 and 7, updated IBC tab to reference guide link
      • Added "AM/CR Opened" column to the Approved, Archived/Expired, and All BUAs section
      • Various miscellaneous bug fixes and enhancements
    • Staff
      • IBC Staff now has the ability to adjust approval/expiration dates
      • Modified IBC Staff page template to add two new sections: Expired BUAs and BUAs expiring in 30 days or less, added conditional display to only show sections that have results
      • Added Two Reports: Expired BUAs and BUAs expiring in 30 days or less

 

  • RSC Changes
    • Form Changes
      • Printer Friendly popups printout no longer displays irrelevant detailed information
      • "Archived" tab renamed to "Archived/Expired" and added a "Withdrawn/Terminated/Approval Withheld" tab
      • Added "AM/CR Opened" column to the Approved, Archived/Expired, and All RUAs section
      • Various miscellaneous bug fixes and enhancements
    • Staff
      • Added the ability to Forward to RSO for review in Administrative Review
      • Added an activity for RSO Approval with an optional comments box
      • Updated/Added email templates for RSO Approval, RSO Review and Submit RSO Review
      • New Homepage added for the RSO containing all the applications/renewals/amendments assigned to meeting or RSO review
      • RSO now has the ability to edit Guidance
      • Added the ability to forward to RSO Review when an application is in Contingency Review
      • Updated RSC Staff page template with conditional display to only show sections that have results
      • Added Two Reports: Expired RUAs and RUAs expiring in 30 days or less
    • Committee
      • New Homepage added for RSC Members containing all the all the applications/renewals/amendments assigned to meeting or in contingency review

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