Question 4.1: "Just-in-Time" has been renamed to "Urgent Review"
Question 9.5: Question is now always shown (used to be for NIH funded only)
Question 22b: Will now show up for HS exempt applications
Question 24: Conditional displays added
Question 35.4: New question has been added ("Will you be recording HIV data?")
Question 35.5: New question has been added ("Will you be collecting or accessing mental health records from a mental health practitioner?")
Question 35.6: New question has been added ("Will you be collecting or accessing substance abuse records?")
Question 36.2: You can now indicate that you are using both HIPAA authorization types
Question 36.2.3: New question has been added ("Please explain why you are obtaining both a HIPAA authorization from the participant and a Full Waiver:")
Form Changes - Continuing Review Application
Question 3.1: New question has been added ("Have there been any subject withdrawals since the last continuing review?") to the Subject Withdrawals section of the application. If the study team indicates yes, they will be required to write-in the number of withdrawn subjects in 3.1.1.
Question 3.1.1: Conditional displays added. This texbox will only show if users indicate yes to 3.1. (used to be question 3.1. prior to this release)
Question 6.3: Conditional displays added
COI disclosures can now be linked for those who login via CHLA Okta
CHLA stamping watermark has been updated
PI assurances has been updated
For CHLA, adverse events will now be auto-acknowledged unless it is serious, unexpected and possibly related. DSMRs will be auto-acknowledged if there is no increase in risk. Slight wording changes
For CHLA, restrict users from submitting new studies if they have expired protocols that have not been closed-out with a continuing review. Allow if they currently have a continuing reviewed opened or in process.
Attendance request emails will be automatically sent out 3 weeks prior to committee meetings for HSC and UPC
New questions were added to "Close Study". This is only applicable to expired CHLA studies. It will ask users to affirm that there were no subject interventions during the expired period and no PHI was accessed.
Auto-Acknowledge for close-out continuing reviews. Only applicable to those studies that are no longer enrolling subjects and category E (Closed/Final Report - All Study Activities Are Completed.) is designated in section 1.2 of the continuing review application. In addition, the following must apply:
No open or pending (under review) Amendments on the study
No open or pending (under review) Reportable Events
Not available for Industry funded studies
No new subject withdrawals since the last continuing review
Risks or potential benefits are unchanged
No new information that should be disclosed since the last continuing review
No new reports in recent literature or multi-center trial reports
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
PIs, CO-is, and Research Assistants now have the ability to specify whether or not they handle animals.
Staff Changes
"Submit Staff Review" is now enhanced to include the following sections from the protocol to assist in the review: Personnel and Training; IBC and RSC Review Status; Funding Information
"Send Pre-Review Email" now has the ability to email selected alternates. By default, it automatically emails to all committee members.
Protocols under Contingency Review now have the ability for reviewers to be re-assigned
Email Notifications for DMR following Pre-Review DMR will no longer be sent
Reviewer Changes
Vet Reviews now have consistent and correct Recommendations options
IBC Reviewers can now add Comments to their IBC Review
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Changes were made to how personnel responsibilities are specified in the application
A new question for "Function of Genetic Inserts" was added to the Genetic Inserts section
Personnel now need to agree to follow the respective institution’s emergency plan in order to participate
Additional CRISPR-related questions were added for the USC IBC application
NIH Guidelines text was updated to be more user-friendly
Printer Friendly version now have details tabulated to reduce page size.
Expiration Notices now take into account that a renewal or amendment is opened and informs the study team accordingly
Staff Changes
Report added to "IBC Staff" Dashboard for the total number of times the following activities were ran in IACUC: Submit IBC Review; Submit Pre Review; and Submit Review
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Text for section 2.1. was updated: "IRB Principal Investigator" is now "Principal Investigator"
Staff Changes
RSC Staff Dashboard now contains items for RSC Annual Report under the "Reports" tab
Staff now has the ability to assign up to three reviewers to a committee meeting
Staff now has the ability to archive applications and PIs can run "Return to Pre-Submission" for applications that are archived.
