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Version 4.2 Information | June 29, 2018

 

  • General Site Changes
    • New support site to track and manage enhancement requests and changes. Allows members from the development committees to submit requests and for the dev meeting to use the agenda and minutes functionality in iStar.
    • Enhanced IBC section of iStar to support submissions from CHLA.
       
  • IRB Changes
    • New COI questions added for conflicted investigator to answer - modeled after the questions currently sent via email
    • Study Form Changes
      • Page 5: Link to protocol help for USC
      • Page 9: investigator Initiated question's wording (9.3.1) was slightly altered
      • Page 9: new question added (9.3.1.1) to capture the Clinical Trials number (NCT number) for investigator initiated trials
      • Page 12: removed the coverage analysis questions (12.3 & 12.3.1) since this is being handled efficiently by CTO at this time
      • Page 13: Q 13.3 has been removed, since the number of charts for retrospective chart reviews is mostly meaningless. The subsequent questions on the page have been adjusted to reflect its removal.
      • Slight text changes in a number of places to spell out acronyms (such as GCP or SCRO)
    • Individual Investigator Agreement requests go out automatically for volunteers
    • HSC IRB can edit the applications under certain conditions
    • Exempt studiers can now be closed. The close study activity has been opened for studies in the "exempt" state.
    • New paragraph added to approval letters at the bequest of the VP for Research that explains that IRB review may not constitute clearance to start your research
    • Monthly reports fixed
    • EUA button size adjusted to fit on the page better
    • Various miscellaneous bug fixes and enhancements
  • IACUC Changes
    • Form Changes
      • Main Protocol Page 3 (Species): Confirmation box is displayed when deleting species from the protocol
      • Main Protocol Page 4 (Documents): Additional column added to Related IBC Protocols section to include link to Section 13 of IBC Protocol
      • Main Protocol workspace:  There is now a flag indicating that the PI is in Non Compliance
      • Main Protocol workspace for Amendments:  A link to the parent protocol, along with protocol name, was added to the summary box
      • Species Section 15:  New question added (15.2)
    • Staff
      • Non Compliance Reports, Send Message to Investigator activity:  Enhanced with a Respond By Date that will send reminders every three days if there is no response from the investigator 
      • Non Compliance Reports and Monitoring Reports:  Added functionality for internal messaging, as well as messaging between IACUC staff and PI.
      • Profile Management:  There were additional training courses that were added:  Level 1, Level 2, Level 3, Level 4 and PI Training
      • Administrative Review now has an ability for IACUC Specialists to "Forward for DMR"
      • Reminders notices:  Reminders are sent daily to reviewers assigned for DMR who have not done their reviews
      • Submit Review:  Enhanced activity for Committee Members to submit their reviews of protocols; merged Submit IBC Review activity with Submit Review activity for IBC reviewers and added new section specifically tailored for IBC reviewers
    • Various miscellaneous bug fixes and enhancements
  • IBC Changes
    • Form Changes
      • Section 6:  Question 6.1. Vectors bug fixed and the question is now required
      • Section 8:  "Biologically Derived Toxins" is now changed to "Toxins of Biological Origin"
      • Section 13:  Wording for question 13.1. has been updated
    • Staff
      • Reports:  IBC Weekly Reports are now also sent to IBC Specialists and Chairs
    • Various miscellaneous bug fixes and enhancements

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