Section 6.1: For USC sIRB studies, checking "CHLA" as an additional location will automatically add it to section 6d. For CHLA sIRB studies, checking "USC" as an additional location will automatically add it to section 6d.
Section 06a.5 is now required.
Section 9.2: Removed "Anatomic Pathology Specimens" from the selection list.
Section 10.1.1: For sIRB studies, target accruals per site must be entered into table. Projected total subject accrual is also required if study is sIRB.
Section 15b: Instructions have been updated.
Section 24.2/24.7: For sIRB studies, add the site that the recruitment/consent document will be used for.
Section 26.5: pop up warning to require “Creation of a data or Tissue Repository” in Section 9.5 has been removed.
Amendment Section 01: language update for consistency with the “Edit Study personnel” activity.
Amendment Section 6d.1: For sIRB studies, other sites/institutions cannot be removed after study approval. Instead, they should be designated as "Active" or "Inactive". Additionally, the enrollment status can be updated for each individual site.
Continuing Review Section 01.2.2: For sIRB studies, enrollment status must be entered for each site (if different from the overall study). Site-specific enrollment status cannot be higher than the status of the overall study.
Continuing Review Section 02.1: For sIRB studies, information regarding number enrolled since last CR must be entered per site. A table with enrollment numbers is generated and mostly prerendered and auto-calculated.
Continuing Review Section 03.1.1: For sIRB studies, indicate which multisites had subject withdrawals.
Continuing Review Section 03.1.2: Modified language to include other sites.
Continuing Review Section 07.1: For sIRB studies, consent documents now indicate which site they will be used for, and the enrollment status of the site.
Changes for Committee / Staff
On the review of CR for sIRB studies, Continuing Review Section 1.2.2 (site specific enrollment status) displayed.
On the review of CR, Continuing Review Section 03.1.1 displayed for IRBAs.
Bug Fixes
"IRB Members" CITI courses no longer count towards Human Subjects Certification for CHLA.
Users no longer encounter internal server error when executing the “Submit Application” activity.
Output the expedited review category numbers in the CHLA “Expedited and Exempt IRB Actions Report” in order.
Site entries in 06d.1 are no longer removed when Section 24.7.2 is hidden.
Amendment no longer withdrawn after “Close Study (Auto)” activity is run.
Continuing Review Section 2.1.1. now shows accordingly if you change the “enrolled since last CR” field.
Cayuse Award Linking API Failure: API was failing due to systemKey being null.
Time in state tab for CHLA studies now show IRB time and HRPP time as separate metrics.
Users no longer encounter the "_sponsorEntities" error when executing the Approve activity on amendments.
Users no longer encounter the "Null is null or not an object" error when trying to save section 9.
Enhancements
USC-CHLA Expedited Progress Update Functionality launched. Expedited or exempt studies that do not have continuing reviews will have due dates set.
If progress update submission is not received after the due date, these studies will be closed.
Progress updates will need to be completed every 2 years.
Notifications tailored to each institution will be sent to the study team at 90, 60, 30, 7-day intervals prior to closing.
Demographics information will also be captured in progress updates.
Misc
Changed user interface for Section D1.2’s document upload for ceded applications.
Header on all monthly Hospital Reports was updated to show the new LA General Medical Center name and logo.
IACUC
Changes for PI / Study Team
Section 1.4 for IACUC protocol now indicates which species that personnel will be handling.
When users indicate they are not handling any animals, they are removed from the checklist in Section 2.4 for all species they were listed as handling.
If there’s only 1 species, everyone who has indicated they handle animals, will automatically be listed as working with that species.
Section 2.4 for IACUC species: study team need to indicate who will be handling that species.
Non Compliance Report "Submit Response" activity updated to be less confusing. "Report" is now called "Initial Report" and hidden by default. A new section called "Latest Correspondence" was added and displayed by default.
Changes for Committee / Staff
An email is sent to IACUC specialists when “Request Reactivation” activity is run on archived IACUC protocols.
Various miscellaneous bug fixes and enhancements
IBC
Various miscellaneous bug fixes and enhancements
RSC
Changes for PI / Study Team
1.4 RAM Permit RAM permits reported here must exist in iStar (Required for ALL IACUC Radiation Applications)
RAM Permit Holder role removed from selection drop down in personnel list as the permit holder is now autopopulated based on 1.4
Changes for Committee / Staff
"Approve" activity now available in "Expedited Review: Pending Confirmation from Committee" state
