Section 2a language update for CHLA. Section 2a removed completely for USC. Section 2.3 removed for USC.
Urgent review questions for Section 4.1 will always show for USC.
Section 5.2 is required since protocol alignment and removal of Sections 11 and 12. Appropriate links to templates attached for USC.
Section 5.3 and 5.5 (sponsor-related) only show if industry funded.
Section 9.1 language revised. Section 9.1.1. and 9.2.1. language has been revised.
Page 13 will now always appear for new applications. Language and title revised.
Page 13.6 will now save properly since the symlink issue has been addressed.
If HIPAA is deemed applicable, page 36 (HIPAA Analysis) will always populate the application.
Page D01 for Ceded review applications:
In section D1.1. the WIRB category was changed to WCG IRB and Advarra IRB was added (both campuses)
In section D1.1. if other is selected, a new question D1.1.1.1 regarding the Smart IRB agreement was added (CHLA)
In section D1.2. language has been revised (USC)
Question D1.5. was modified to be a simple heading above the engagement questions (both campuses)
Hide/Show functionality was removed for engagement questions; always visible now (both campuses)
Question D1.5.4. language was revised (both campuses)
Bug Fixes
NSHRs should no longer be able to be submitted as they have been fully incorporated into the main application.
Section 2.1 no longer prevents users from being added if they were obtaining consent and did not have current GCP certifications for non-clinical trials.
Approval Letters no longer contain unencoded characters
Section 18.1 now saves edits without issue
Scientific Reviews no longer automatically route to a single entity
Enhancements
IIA Attestations now contain hyperlinks to the various materials (Belmont Report, Code of Federal Regulations).
New Log IRB Compliance Note functionality was added for studies and reportable events. This will allow the IRBA to add any comments related to non-compliance on the study. In addition, a new compliance note will get auto-generated when any non-compliance related reportable event is acknowledged; the note will contain a link to the reportable event. These notes can be found from the main study workspace under the new Compliance tab.
Various miscellaneous bug fixes and enhancements.
A 90 day renewal notice for studies due to expire was added for CHLA.
A new hide/show button was added to the Meeting workspace. This pertains to meetings that have a remote meeting link and will show/hide the meeting instructions.
IACUC Changes
Form Changes
New species added: Galagids
Changes for Staff
Specialists now have ability to un-suspend a protocol when an amendment or renewal is approved. New motion added when recording meeting results.
Veterinary reviews are now called verification; Motions for the verification were updated accordingly
