Section 6a.2 Investigators can now specify which LA General Service Areas will be utilized in their research.
Section 6a.5 is now required to answer for DHS.
Section 15b has new questions added.
Section D1.2 allows for categorization of documents (IRB Auth, Approval, Protocol, Consent Form, Reliance Documents).
Changes for Committee / Staff
IRB Administrators can now add comments when using the "Return for Pre-Review" activity on Amendments.
CHLA Expedited-Exempt IRB Actions Reports now have types sorted by review category.
Studies: PHI warning message now appears in section 40. Additional Supporting Documents.
Studies: PHI warning message now appears on Send Message to IRB and Log Comment activities.
Reportable Events: PHI warning message now appears in section 17. Participant or Other Complaint and 18. Annual Report Submission.
Reportable Events: PHI warning message now appears on Send Message to IRB and Log Comment activities.
Bug Fixes
Fixed issues that could occur when using the activities for "Submit Application" and "Agree to Participate in Study".
Fixed issue where users couldn't save answers to Section 9 despite indicating a NCT number for investigator initiated clinical trial studies due to outdated reference.
Fixed issue where reassigned primary reviewers were unable to review adverse events due to insufficient security permissions.
Fixed issue involving section 9 of the continuing review application where study locations from 6d were not appearing. All sites now appear section 9 and are in alphabetical order.
Fixed issue involving approval letters missing approval date and action(motion) after investigators respond to contingencies.
Fixed issue involving iStar banner missing from the Meeting Agenda and Minutes pages.
Enhancements
IBC Review functionality has been added. IBC Review is required when Biohazardous Substances or Gene Transfer Study is selected.
Dept/Div Review functionality for LAG service areas and departments available - will be implemented on LAG's timeline
To be deployed in January 2024, new functionality to enhance post-approval monitoring for both USC and CHLA will require exempt and expedited studies without continuing reviews to submit progress updates. Lack of action will result in study closure.
Misc
CTO now have read-only access to Emergency Use/Compassionate Studies
IACUC
Changes for PI / Study Team
Reduce Training Burden for Staff: New section 2.4. was added to Species to specify which staff is working with that particular species so training would not required for all species defined inside protocol. This information is reflected in the Personnel section under the "Animal Handling" column.
"Time" tab added to Main Protocol workspace to show the processing time with Study Team & IACUC.
Changes for Committee / Staff
Agenda: New sections added for "Adverse Event" and "Anonymous Adverse Event"
Content Management of Buildings/Rooms was added to the IACUC Specialist & Vet Dashboards
"Reactivation" notification is now sent to IACUC Specialists when it is requested
Monitoring Reports now have the ability to send a letter to the PI
IACUC Adverse Events ready for internal use
Various miscellaneous bug fixes and enhancements
Link to the AOPS protocol has been added to the workspace.
IBC
Changes for PI / Study Team
ECP Section 2.4. for CHLA is now required only for new submissions
New activity called "Generate Biohazard Communications Sign" was added to auto-generate door signs to be posted at labs
New textbox added to Section 10 for Cell/Tissues Types to ask for further details
Section 14.1. Locations now account for offsite locations
Toxins (Section 8) and PIM (Section 9) are removed as options Research Location (Section 14.1.) automatically if they were previously selected and were removed from their respective sections
Host Vector Genes (Section 6) is automatically updated when Section 3, 4, and 5 are updated
"Animal Research" Personnel role removed for USC
Changes for Committee / Staff
Approval & Expiration Dates inside Message Templates are now corrected
Various miscellaneous bug fixes and enhancements
RSC
Changes for PI / Study Team
Responsible Individual for Submission Updated: For IRB & IACUC submissions, the PI is the one responsible for submission. For Use Permits, the RAM Permit Holder is the one responsible for submission.
Changes for Committee / Staff
Agenda: the "PI/Permit Holder" column details who these individuals are more clearly.
Various miscellaneous bug fixes and enhancements
General
New automated report functionality that sends excel spreadsheet based reports by interval to the users specified in the configuration. It uses a custom search, so most saved searches can be used as a report.
