Ceded Review, Page D1 has been significantly reworked
New question asking about employees going off-site
New question asking whether study activities happen at USC or CHLA - which trigger engagement questions
If study activities happen, always ask for a description
studies from Cedars or NCI CIRB are assumed to be here and get the rest of the pages, no engagement questions
For a study approved by another IRB and USC is engaged, Warns the investigators that an IRB Authorization agreement will be necessary and IRB Directors have the ability to associate an IRB Authorization Agreement with the Ceded form
Ceded applications get auto-acknowledged (moved to "Not Engaged") for which no activity is being done at USC/CHLA, nor are employees going off site
New ability the IRB to capture and manage IRB authorization agreements (for when another IRB is the IRB of record)
LAC review capability added for studies that are to be conducted at LAC+USC
Studies that are to be conducted at LAC+USC also have a flag to indicate whether the study is still under review by LAC or has been cleared.
Study Personnel (2.1) and the Edit Study Personnel Activity now include questions about whether the person will be interacting with participants and whether he/she will have access to identifiable data
Study Personnel role "SubInvestigator" has been reinstated with restrictions - now only persons with the position types of "Post Doc, Resident or Fellow" or "Graduate Student" may be identified as a Subinvestigator
SubInvestigators' departments/divisions are now included in the department/division sign offs upon submission
Page 2a - Engagement questions for outside collaborators have been altered to better determine whether the study needs to add the person's institution at 6c
Page 2a - new question added to determine whether any study activities will occur at the institution
Page 6c.1, 17.1, and 18.1: The hide/show functionality for these pages has been altered to be unique so the printer friendly and view differences functionality show the relevant fields correctly
The iStar new account registration form has been significantly reworked to improve usability, readability, and data accuracy
Close Study activity now creates an acknowledgement letter upon execution
Conflict of Interest Review activity now sends a notification email to the IRB administrator
Fixed bug where the study team could not access amendments created prior to being added to the main study
Fixed bug where the study team could not submit changes if the application is a HUD
Updated the NHSR application to address a validation bug which prevented users from being able to submit their application via the Finish button on the last page.
Added a log comment activity to the Emergency Use application.
Updated message templates for UPC to use a simpler format.
Updated the submit expedited review activity on amendment to display the correct expiration dates for flexed studies at CHLA
IACUC Changes
Added Pilot Study questions to Renewal page
Added Info Box into Create Renewal and Amendment activities and its related views
Added various Reports for IACUC Specialist and Vets
Fixed Monitoring box display and added message to inform if monitoring was involved
Administrative Review is now available for Renewals
IACUC Specialists can now Request Changes in Administrative Review
Modified History Log to include Monitoring related information when Reviews are submitted
Updated references from IACUC Coordinators to IACUC Specialists
Updated default IACUC home page tab
Fixed Approval Withheld state Summary Box
Addressed IBC/RSC validation issue
Updated Recommend Monitoring
Updated Email Templates including Renewal emails
IBC Changes
Updated Section 1.2.4. - added selection agents/toxins and new questions
Email Reminders are now sent for OHS expiration
Added Controlled Substance Requirements Report for IBC Staff
