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Version 3.4.1 Information | May 9, 2014

  • IRB Changes
    • IRB Application form changes
      • Page 9: option for Biohazardous Materials edited to include examples
      • Page 14: instructions added
      • Page 18.1: Device detail form edited to insert "in vitro" to diagnostic device category for exempt from the IDE regulations
      • Page 25: options for cost and injury updated
    • Amendment form for HSC for clinical trials adds two questions to help CTO find and review amendments in a timely manner
    • Expedited reviews include approval date for clarity
       
  • IACUC Changes
    • Warning added to page 1 regarding 3rd year renewals
    • Copy protocol bug fixed
    • Monitoring functionality enhanced for use by veterinarians
    • Expiration/Renewal dates added to reminder email templates
    • Fixed Meeting tab display for IACUC Chair, IACUC Coordinator, IACUC Member and Veterinarian to show only future meetings instead of all meetings
    • Modified IACUC Coordinator home page to hide approved, withdrawn and pre submission items for ‘IACUC Protocol’, ‘IACUC Amendment’, and ‘IACUC Renewal’ tabs
    • Added ‘Protocols’, ‘Amendments’, and ‘Renewals’ tabs for IACUC Member home page
    • Modified Species 7.3 (new line) question in Biohazard page to be available for all species
       
  • IBC Changes
    • New icon for carcinogens
    • Fixed emails with nulls
    • Added Notes textbox for ‘Assign to Committee Meeting’ and modified History Log to include members assigned to meeting when assigned
    • Fixed validation issue where both 12.1. and 12.2. needs to be answered (should be either) when 1.5.1. was checked yes
    • Added checkboxes for Section 12: Admin Controls, PPE, Waste Disposal, Emergency Procedures
    • Fixed the issue with the 1.5.2. SOP message
    • Added a box for “Comments Not Requiring Response” in IBC Member Review
    • Added validation to ensure that 1.5.1 needs to be checked Yes if 1.5.2 was checked Yes
    • Added Frequency (13.5), Anesthetized or Restrained (13.6 and 13.6.1) to Live Animals
    • Added ‘MSDS Chemical or Biological Exposure Control Plan’ selection for Document upload
    • Added “Responsibilities” to Personnel table
    • Send to Chair for Expedited Review’ default to show Specialist Review activity
    • Added NIH Summary in main BUA workspace
    • Defaulted Appendix C to always show unless ‘No’ is selected for Section F-8
    • Enabled IBC Staff role to Assign Specialist or IBC Specialist to Take Assignment in Staff Review
    • Enabled ‘Forward to BSO’ activity in Specialist Review
       
  • RSC Changes
    • Committee members now have access to related IACUC or IRB studies
    • Added new Radionuclides to the system and reorganized dropdown to sort alphabetically
    • Added ‘Other’ in Personnel role dropdown to accommodate individuals who want to be associated with protocol, but is not doing the actual work
    • Imported LSIS Radiation Safety Permit data into iStar
  • Emergency Use Changes
    • Altered form to include compassionate use of a device
    • IRB chair concurrence activity created

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