Page 2: Question 2.3 hidden for USC. All persons on a study must have an iStar account
Page 4: New question for Just-In-Time grant submissions plus document upload to establish need
Page 6c: AltaMed has been removed as a CHLA site. Sites that use AltaMed at CHLA must add AltaMed in 6d as a separate site
Page 14b: New page for detail about blood draws (For CHLA, and for USC only if venipuncture is the only procedure)
Page 22d: The questions have been edited and (for CHLA) two new questions have been added asking about translation for study documents and study instruments
Page 22j: The questions regarding Military personnel as study subjects have been moved to 22j to facilitate those questions being asked of studies that do not receive DOD funding. At this point, the option to select military personnel on 22.1 will be restricted to UPC.
Ceded Review: functionality to capture and manage reliance agreements within the system has been created
Ceded Review: New review checklist for review of ceded studies has been created
Ceded Review: indicators on study workspace, amendment workspace, and reportable event workspace have all be created or made consistent
Individual Investigator Agreements are now created and managed within iStar
Scientific Review: Snapshot of the review now take at the time of submission
Scientific Review: Ad hoc committee functionality created which allows the Scientific Review administrator to designate iStar members as reviewers for a study, which then allows those chosen to access and review the application
Exempt: for UPC, exempt studies will no longer receive the recruitment and informed consent page, but rather will see a page describing to them their duties and referring them to the information sheet template
Informed Consent documents on 24.7 will not be accessible from the documents tab on an approved study
When a study is approved with contingencies, no approval or expiration dates will be automatically generated by the system
Review of Continuing Review: COI page has been removed, since COI changes are all reviewed on Amendment, not at continuing review
DCG gets the checklist email if a clinical trial is grant funded
Sponsored clinical trials get assigned to CTO groups automatically
DHS research support type is now required during review of HSC research that occurs at LAC
OnCore links are now displayed consistently on study summary pages
New Reports for CTSI
Time tab has been updated to store values on the study
NHSR name and links have been updated to make more user friendly
Various miscellaneous bug fixes
IACUC Changes
All IACUC listed in the personnel section must now have a valid OHS before a new protocol, amendment or renewal can be submitted
PIs are now informed whether or not annual renewal or third year renewal is necessary when they try to create a new renewal or amendment
Surgical Personnel under Species 16.7 now requires personnel to selected instead of a freeform text field
Training icons for researchers have been updated so that OHS is the first to appear in the list if it exists in the user profile
OHS related updates including new reporting, reminders, and new fields for whether individual handles animals and active IACUC protocols
Monitoring Reports has an updated workflow, as well as new fields to update monitoring status. It is also now limited to one monitoring report being opened at any one time. Workspace for DAR staff and Vets are now updated so they are consistent.
New mechanism for communication between the IACUC and study team inside protocol
Non Compliance report updates including the update of IDs to use usernames and a new Non Compliance inside the protocol page for DAR staff
DAR staff can now assign a protocol to Full Committee after DMR
Various miscellaneous bug fixes
IBC Changes
New fields for OHS, including a field to specify whether or not an individual requested to be opted out, have been added to the user profile
New OHS related reporting now available to IBC staff under the Reports tab
Various miscellaneous bug fixes
RSC Changes
Device Operators are now selecting from a new set of certificates/permits when entering procedures
1.6.1., 1.6.2., 1.6.3. have been updated to be one line textboxes
1.6.2. has been updated to say "Please indicate the specific sections of the informed consent that contain pregnancy testing language"
2.6.3. has be updated to say "Please indicate the specific sections of the informed consent that contain radiation safety language"
Under "Radiation Dosimetry" question, "include units" have been removed
The Study Box in 1.6 now automatically pulls IRB application 4.1 Funding info checkboxes
RSC Staff now have the ability to reschedule committee meetings for RSC applications
