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Version 3.5.4 Information | September 25, 2015

 

  • IRB Changes
    •  Form Changes
      • ​Institutional Conflict of Interest question moved from page 39 to page 1. New number is 1.6.
      • 9.2 once again has an "Other" option to check.
      • Neonates options have been adjusted to reflect a "less than 30 days" rather than "30 days or younger" definition
      • Retrospective studies get some of the special subject populations sub pages resulting from selections in 22.1
      • Exempt studies skips the risks page altogether instead of only showing a subset of the questions
      • Amendment page 1 now included the change in risks question that used to be only on page 6.
      • Amendment Q 5.3 will now ask for an explanation if people have been enrolled but need not be informed of the changes
      • Amendment page 9 - Question 9.1 has been altered for clarity, so as to elicit an overview of the changes and purpose, rather than an enumeration of the changes
      • 35.2 and 35.3 are only required if 35.1 was answered Yes
    • Submit to IRB and Co-Investigator agree to participate activities now include new Conflict of Interest questions
    • For studies that have been reviewed at full committee without a final management plan in place for conflicts of interest, the management plan will appear on the next agenda of the IRB that reviewed the study
    • Exempt studies that get flexed will retain their exempt status (instead of going to exempt flex) so that the forms retain the exempt pages.
    • New DHS clearance functionality for studies that are to be conducted at LAC and have obtained LAC clearance. Such studies must also be cleared by DHS
    • For UPC studies, new IRB pre-review options support UPC's new method of reviewing studies
    • The algorithm for determining whether the study has to wait for clearance from CTO/DCG has been altered so that internally funded studies need not await CTO review
    • The activities for conflict of interest review have been altered and simplified for clarity
    • Pending Emergency Use Applications now are now viewable from the IRB Director workspace
    • Web Service for integration with the OnCore clinical trial management system
    • Letter templates have been edited for readability and clarity
    • New reports for CTSI reporting needs have been added
    • Committee Chair can submit compliant report or submit participant or other complaint
    • Fixed bug where 4.3 would sometimes fail to show under the Printer Friendly View
    • Various miscellaneous bug fixes

 

  • IACUC Changes
    • View Differences bug fixes
    • Non Compliance Reports can now be submitted by Vets/Staff
    • Monitoring Reports section now added
    • Vet homepage Monitoring tab now no longer shows completed reports
    • Question 3.4 was added to IACUC Species page
    • Checkbox for email was added for Designate for Monitoring and Edit Monitoring Status activities
    • Agenda and Minutes for committee meetings have been improved
    • Agenda Items: Removed Other and Minor Revisions; Renamed Major Revisions to Amendments
    • Various bug fixes for Monitoring Reports
    • Various miscellaneous bug fixes

 

  • IBC Changes
    • View Differences bug fixes
    • Study Contact role added to Personnel; emails sent to PI will also be sent to Study Contact
    • Approval Memo templates for BUAs and Amendments modified
    • Exempt Review now removed from workflow and Expedited Review modified (forms and workflow)
    • In State Too Long Emails added: Staff, Committee Members, PI (modified)
    • Weekly Summary Email added for IBC Staff
    • Inspection Reports can now be added to BUAs
    • IBC Staff homepage bug fix to show BUAs in Bio Safety Officer Review
    • 10.2: Uploaded document title now shown in the editable application

 

  • RSC Changes
    • View Differences bug fixes
    • Fixed bug where RAM applications showed up under Amendments
    • Fixed bug where applications would sometimes not transition from Contingency Review to Contingencies Pending

 

  • Meeting Changes
    • Agenda Items can now be sorted by PI, ID, or title

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