(CHLA)Page 50: Questions related to IT Security were refined a bit to aid the IS Clearance process
(CHLA)Page 50: Question 50c.2.7.2. was added to allow users to list devices not managed by CHLA I.S. Users can now add descriptive data for each device.
(CHLA)Page 50: Question 50c.2.4.1. was modified to add a new "Not Applicable(N/A)" category for those cases where review from Laboratory Medicine is not needed.
Bug Fixes
Reactivation of archived protocols with a recently auto-acknowledged CR no longer throws errors
(CHLA) Reportable events to align with unstructured review since RE update
Page 50: Fixed question 50c.2.5.1. so that users can add a Laboratory Letter of Support from Pathology on Ceded reviews.
Fixed an issue that prevented the Dept/Div reviewers from executing the Approve activity after the study team submits their response to requested changes.
Corrected the regulation reference for minor changes to previously approved research
Misc. Functionality
Ability for IRBAs to prioritize their queues for “My Complete Inbox” on their dashboard
(USC) New activity (“Attest to COVID-19 Polices”) - all study team personnel who will be obtaining consent or interacting with participants will need to attest to the guidelines. PIs who head these studies will need to upload an approval notice from their school. Applicable individuals who are to be added onto an approved study (non-exempt) via “Edit study personnel” or amendments will have to fill out their attestation on their dashboard. When all direct interaction personnel have attested, an email will be sent out to the PI notifying them.
(USC) COVID CRRPC email notification to committee for approved biomedical studies
(USC) Revised COVID-19 questions; implemented sorting mechanism for COVID studies; both functions deprecated as of 6/17/2020 as OPRS determined COVID studies will no longer be granted queue priority
(CHLA) Added the CHLA MIS Security Policy Attestation to the Submit Application activity. The PI will need to check I Agree before they can submit their study.
(CHLA) The functionality that warns the PI if they have a study expired over thirty days was enhanced; this warning appears at the top of the Submit Application activity and it now includes a direct link to the protocols. Rather than searching for expired studies in their inbox, this will allow the PI to quickly access these protocols and save time.
Management Plan notices now have a direct link to the related study.
(CHLA) Past due notices for Expired studies were revised to comply with the new guidance from CHLA. The first past due notice will go out at 15 days after a study expiration. The second notice will go out after 30 days and a final notice will go out at 90 days after expiration. The language contained in the past due letter templates was modified to comply with the new guidance.
(CHLA) The expiration letter that is sent at the time a study expires was revised with new language to comply with the new guidance from CHLA.
(CHLA) New warning language with instructions was added to the Request Reactivation activity for archived studies.
Emergency Use applications can now be reassigned to a different chair
Studies submitted to the USC Social Behavioral IRB from the HSC campus will undergo dept/div review
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
Protocol 1.6. was removed for Accounting contact. Financial Administratorwas added as a new role when Personnel is defined in Protocol 1.4. Previous Protocol 1.7. question is now renumbered to 1.6.
Wording for Species 1.6. question was updated and Species 1.6.1. was added regarding adoption program
Species 1.4. was updated to include the ability to select Common Strains for Mouse and Rat. Previous strain entries are now in Other Strain.
New Species 1.3.1. question was added to ask abut whether or not any animals were obtained externally from a peer institution
Species 5 for Anitbody Production was updated for wording and revised with more subsection questions.
Staff Changes
Chair Confirmation of Meeting Resultsno longer required in the workflow for protocols and meetings
Protocols Assigned as Pre-Review DMRs now get reminders every two days if it has been assigned to a Pre-Review meeting and the designated reviewers have not submitted their reviews
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
CHLA: Question 16.8 added for in vitro and in vivo, along with a textbox for explanation
CHLA: Textbox for detailed explanation added for Manipulations sections: 6) Host/Vector/Genes; 9) Potentially Infectious Microorganisms; 10) Human Cell Lines; 11) Animal Cell Lines
Hep B opt out/training icons will now appear based on whether or not they exist, instead of the user's campus affiliation
Staff Changes
Staff now ability to Assign to Committee Meeting meetings that occurred within the last 30 days, as well as for future upcoming meetings
CHLA: Chair Confirmation of Meeting Resultsno longer required in the workflow for protocols and meetings
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Device Supervisor was added as a new option for Personnel
List of Isotopes have been updated and the question has been converted to an selection entry instead of the current dropdown
Staff Changes
Approved since the last meeting section on the Agenda has been updated to include protocols approved with the Contingency Review process
