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Version 3.5.1 Information | December 19, 2014

  • IRB Changes
    • IRB Application Form Changes
      • Page 2: Scientific Review question now has checkboxes
      • Page 2: CHLA studies get asked the scientific Review Question (2.5)
      • Page 2a: questions on outside collaborators include institutional engagement questions
      • Page 6: if both an USC campus and CHLA are chosen the engagement questions appear for activities at the site other than the one that the application will be submitted to
      • Page 6: edited 6.2. and 6.2.2. for clarity
      • Page 9: Radiation safety application shows the approval letter
      • Page 14: Biosafety application shows approval letter
      • Ceded Page D1: Edited engagement questions (D1.4-D1.7) to have campus that the questions pertain to within the questions; hide D1.2 if D1.1 is CHLA or USC
    • Flexibility Policy available for CHLA for two year approval of certain expedited studies
    • Scientific Review activity and architecture added
    • Adverse Events: activity added for CHLA IRBAs to document staff review decision to send to full board, chair, director, or send acknowledgment letter
    • Amendment: Question 1.2 altered to combine protocol and procedures and add new checkbox for locations
    • Amendment: Questions that trigger CTO review for Clinical Trial amendments have been edited
    • For studies conducted at the USC CTU, the CTU will get emailed upon Amendment submission and Continuing Review Approval
    • CHLA IRB will have ability to edit Full Committee applications (at certain times)
    • CHLA SPA can use the "Contract or MCA Consistency Review" activity for CHLA studies
    • UPIRB can add a DoD checklist when sending a study for review
    • Access to studies by Ceding IRB only granted on approval, not on submission
    • Participant complaints will notify IRB director and be assigned to the director instead of the IRBA assigned to the study
    • Edited Reportable Event workflow script to assign current UP chair to UP Reportable Events
    • Edited pop up approval documents page to not show HIPAA documents section if no HIPAA documents to show.
    • Adverse Events: Question 1.2.1 is now required if it is a follow up report.
    • Continuing Review and the review of continuing review: Added the DSMB frequency question (27.3.3) to Page 4 and CR05 respectively.
    • Modified the UPC approval templates for certain project types
    • NHSR: The Not Human Subjects Research application will no longer contain a timestamp in the title; instead, it will automatically get pre-populated with the author's name.

 

  • IACUC Changes
    • Implemented Administrative Approval
    • Added reports for IACUC Coordinator homepage
    • Added ability to reassign to Pre Review in Contingency Review: Awaiting Correspondence state
    • Redid permissions for various activities
    • Fixed bug for IACUC members to not be able to see internal IACUC actions on protocols that they are on
    • New Role for IACUC Staff - read only access to protocols
    • Added additional guidance to Surgical Procedures page
    • Added Description box for Monitoring
    • Added Monitoring icon and hover description in Agenda if protocol is designated for Monitoring

 

  • IBC Changes
    • Approval letter templates edited
    • Fixed Forward to Contingency Reviewer email issue
    • Fixed Ad Hoc – Bio Safety Specialist/Title bug
    • Modified Personnel popup to be similar to IACUC

 

  • RSC Changes
    • Types of Certifications are now mandatory
    • Duration of an IRB study is displayed once one is selected and saved
    • Various Show/Hide updates for Rad Use Permit
    • Added ability to Send Back to Committee in certain states

 

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