Reworked view, edit, and compare features for applications
New review systems for committees
Returns to where you left off for a form
New Printer Friendly functionality allows for the configuration of different print packets
Creating New Account (Shibboleth): Can now select Student if both Student and Staff
OKTA Integration for log in and creation of new accounts for CHLA users
Ad Hoc item display on agendas & minutes have been fixed
Certifications found in user profile page is now collapsable and contain training/contact information
IRB Changes
Form Changes
Page 2: remove question 2.3 about outside collaborators for CHLA (USC had already removed this question)
Page 3: Move to the end of the Study form (page 50)
Page 4: On item 4.4, reword the question asking for funding information to be uploaded
Page 5c: Remove Q 5c3 and bolded information just prior (now dealt with in the new question about data being submitted to the FDA)
Page 9: We now ask studies (including exempt) whether any data will be submitted to the FDA
Pages 10,11, and 12: Change refer to protocol admonitions to include CHLA
Page 14b: Removed page 14b to ask for detail about blood collection
Page 15b: Removed page 15b for submissions to an existing repository (was CHLA only)
Page 22: Change "Normal Volunteers to "Healthy Volunteers"
Page 22c: New Checkbox Statement for 22c.5
Page 22d.2 - change option to include sponsor
Page 22h Augment page on Wards to include Federal criteria
Page 24: Reword and reorder the options for informed consent. Change "information sheet" option to be a "waiver of signed informed consent"
Page 24: CHLA: Simplify informed consent page for exempt studies
Page 24a: Change to Wording for Assent to Match SOPs
Pages 24a and 24p: Change wording and order of assent and parent pages to conform with main IC page
Page 26: Question 26.5 - Wording Revisions
Page 26: Q 26.6 Updated Certificate of Confidentiality Note
Page 26: Now required for Exempt Retrospective studies, as under the new rule the data may contain identifiers
Page 42: New page for supplementary Clinical Data Warehouse Questions
Page 50: Required Review page gets a number of new questions for CHLA to ensure that all departments and ancillary committees review the research
Page 50: combined functionality for pre-submission and post-submission pages so always use the same page
Ceded Review Page 1: remove the old "CHLA checklist" from the page
Ceded Review Page 4: ADD New question on who gets the funding
Ceded Review: Page D1: new options for D1.1, some new possible questions and updated instructions
Ceded Review: Remove page 10
Ceded Review: Page 24: remove Question 24.1.4
Ceded Review: remove page 25 for CHLA
Ceded Review: Update page 26 to be the same as the main application
Ceded Review: Remove Page 40
Ceded Review: remove page D2 for CHLA
New Ancillary review functionality for CHLA - HIROC, RSC and Information Security can review concurrently with IRB
Clinical Trials Designation & New Rule on CR Reviewer Pages
Committee Portal pages from the "Home" section has been removed
For HSC studies, the "Send Message to IRB" function will now email the IRB
Institutional Conflict of Interest: Now shows on workspace and can be reviewed by COI administrator
IRB Administrators can now send studies back to the study team while it is in the "Awaiting IRB Administrator Assignment" state
Language about the limitations of approval has been added to a number of templates
Reportable Events: New start page for CHLA, where investigators are informed of CHLA policy and must indicate the sort of information they are providingReportable Events: Changes to Reviewer Determination to make it more flexible
Reportable Events will now show if an amendment is open on the workspace and vice versa
Remove Ward Warning for Exempt Research
Remove Director Sign off for USC Individual Investigator Agreements (IIA)
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
Add Personnel Details text have been updated to reflect iStar account creation with USC NetID and Oka logins.
Fixed display bug on page 3, IACUC protocol
Forward to Contingency Review: Reviewer #1 is now required
Fix undefined errors on Protocol page (assigned to pre-review)
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Page 1 error messages have been updated
CHLA: Add Human Derived Materials (HDM) to ECP
Renaming the Title of Section 15
Add Submit Application button for Page 99
CHLA: Hep B vaccination/opt out dates added to user profile. "Agree to Participate" will prompt user to opt out of vaccination or update records before proceeding.
Add Required Fields to ensure the form is filled out completely
