The iStar system was MOVED to a new dual server configuration hosted by USC ITS
Updated Windows Server OS (2019) and SQL Server (2019)
The Version of Huron Portal has been updated from 9.0.4 to 10.0.3. Version 10 of Portal has many enhancements and changes, including:
New versions of Windows and SQL Server
New Dashboard possibilities, including more personalization options
Faster responsiveness for searching and browsing projects
Native snapshot support
Accessibility improvements to dialogue boxes and other "fly out" windows
IRB
Form Changes
Section 2.4 cancer center related language changes.
Section 5.2. Specific protocol template links removed, replaced with generic link to OPRS templates and forms page.
Section 9.1.2. for PI level plan upload is no longer required.
Section 13.3 and 13.4 hidden for CHLA.
Section 14 will be available to all review types if "Biohazardous Substances" is selected under Section 9.1.
Section 22D.1. language revised to reference "qualified interpreter" with definition included.
Section 22D.2 and 22D.3 have been removed on new applications. Study personnel will have to request IRBAs add translated versions of consent forms to Section 24.7.
Section 35.5 and 35.6 now have corresponding document upload sections. Users no longer have to navigate to Section 40.1 to upload related documents.
Section 41.1 through Section 41.4 are now required to answer prior to submission.
Ceded applications route to Section 42. CRI team will be notified if CDWs will be used.
Bug Fixes
Studies that receive cancer review approval is not required no longer remain in "Cancer Center Review" state; they are instead redirected to the next state accordingly.
Option to select applications as CG re-instated.
Section 22j will now populate for exempt USC applications if military personnel is indicated.
Fixed instances where users were receiving an error when removing personnel via "Edit Study Personnel" activity.
"Forward to Expedited-Exempt Reviewer" activity now shows chairpersons for all BioIRB committees.
Fixed the issue in the summary area where "undefined" appears above the status bubble on approved grant submissions.
Enhancements
Misc
IRB Administrators now able to assign studies to either the BioIRB/SBIRB committee meetings using the same form.
For USC, co-investigators now require amendments to be added onto study team personnel after an application has been approved.
Study personnel Personnel on HUD, CG, and coded data applications are no longer subject to Human Subjects/GCP/HIPAA certification requirements.
Reportable event approval letter had minimal language changes.
On submission, users will be required to have current Human Subjects certification, GCP (if Section 9.3 is answered as "Yes"), and HIPAA (if Question 35.1 is answered "Yes"). Users will be prevented from submitting if certifications are expired or due to expire within 30 days. Applies to amendments, continuing reviews as well.
Vice Chair Queue reports for SBIRB and BioIRB renamed.
Committee members can no longer execute "Log Comment" activities.
IRB contact information updated on template correspondences for various project types.
The Committee Member Review activity will now show the current state as a bubble graphic (in red) on suspended studies if they answer No to "Should the study be Suspended . . ." question. Furthermore, if they indicate Yes to the lift the suspension question, the next state will get shown as a bubble graphic (in green).
Reportable events that involve serious or continuing non-compliance that don't get reviewed by the full board will now display the Chair's review in the compliance note.
IACUC
Changes for PI / Study Team
Species 10-3 Drugs & Controlled Substances, Species 20-1-1 Euthanasia Questions are now Default to Yes and those questions are now required
A "Notice Box" has been added to the "IACUC PI & Staff" dashboard indicating that they have a Non-Compliance Report that is pending their response. The box will only appear if there is a Non-Compliance Report awaiting PI response and they are the PI.
A Third Year Renewal reminder was added for 120 days prior to expiration
PI and Authorized Submitters can no longer Request Reactivation on Archived Amendments and Renewals/Continuing Reviews
Changes for IACUC Committee / Staff
Forward to Contingency Review now have options to notify CS, RSC and IBC
New report added for IACUC Semi-Annual Inspection, Real Time numbers added and Site Search removed in IACUC Chair Dashboard
Various miscellaneous bug fixes and enhancements
IBC
Changes for PI / Study Team
User training for OSHA Bloodborne Pathogens, Principles of Biosafety, Shipping of Biological Materials and Dry Ice, and Viral Vectors/BSL2+ now appears in the personnel section. Biosecurity is no longer displayed.
Changes for IBC Committee / Staff
iStar is now the system of record for training records; added ability to manage the various training in user profile
SARS-CoV2 research report was added to the "Reports" section of the IBC Staff Dashboard
