Section 2.5 was hidden for CHLA as they do not utilize the scientific review functionality.
Section 6 (Locations) was moved to page 45 to help facilitate specific location requirements needed for research occurring at the Keck School of Medicine.
Section 45 (Locations) no longer shows CHLA as an option for USC studies or USC for CHLA studies on question 45.1. Studies involving both organizations should add the other org as an "other" and provide detail on page 45d.
Section 45 (Locations): For USC applications, Los Angeles General Medical Center now has their own page.
Section 45a (USC Locations): USC locations are now condensed to one page. HSC and UPC have their own sections on the page.
Section 45a (USC Locations): LA General locations are no longer available for new applications.
Section 45a (USC Locations): Studies that interact with participants, have medical procedures and select Keck School of Medicine will be asked whether those medical procedures occur on KSOM locations. Specific locations are available to choose. Any "other" selection requires KSOM office of research approval.
Section 45b (LA General Locations): now includes the service areas utilized and LAG resources requested as new questions. This supports the eventual retirement of the LA General document based sign offs in favor of an iStar based clearance process.
Section 45d (Other Locations): Can now add site-specific enrollment numbers and consent documents for single IRB studies.
Section 26.5.2 and 26.5.3 were removed for CHLA (originally for IT Security team review but deemed unnecessary).
Continuing Review, Section 1.2.1 (for USC only) changed to require explanation for all enrollment changes, not just changes to close enrollment. The "Update Enrollment Status" activity was also hidden from execution, preventing users from changing enrollment status without a CR or AM.
Continuing Review, Section 2.1 error message language updated to reflect requirement to open an amendment to alter study target accrual regardless of intent to enroll.
Continuing Review, Section 2.2 (for USC only) revised for new CRs. New questions to determine if there are multiple cohorts/phases and if so, to require upload of a document to explain the enrollment into different cohorts.
Continuing Review, Section 5.1.1 (for USC only) was newly added and is displayed when parent study has indicated "Creation of Data or Tissue Repository" under Section 9.2 "Study Procedures" (to gather information about the research repository).
Continuing Review, Section 6 updated language and functionality of 6.1 and 6.2.
Continuing Review, Section 7.1 language updated to accurately reflect business process (IRB doesn't typically stamp recruitment documents).
Continuing Review, Section 9a.1 has new guidance for USC to require amendment submission and upload of current IRB approval letter. Also hid Section 9a.2 on the CR as well as the review of CR (for staff).
Continuing Review, Section 9.1.1 was hidden for USC as it's not currently relevant (COVID related question).
Emergency Use, Section 1. was updated to show a notice regarding tissue requests which cannot be processed via this type of application. The notice appears at the top of the page.
Emergency Use, Section 1.6. was updated so that the caption will always reflect the type of test article chosen in 1.5.
Emergency Use, Section 1.6.5. was updated with new instructions regarding authorizations/waivers from the FDA.
Emergency Use, Section 1.6.5. will now show a warning box if they indicate No to this question with instructions to start an IRB application.
Changes for Committee / Staff
Section 2.1 table for the review of CR form now includes multisite numbers (subjects enrolled since last report and previous enrollment) for previous CRs separated by site. Also displays the total and future allowed enrollment of all sites. Summary section of the CR workspace now accurately reflects enrollment numbers for multi-site totals, not just "at this site".
Printer-friendly view for Section 2.1 now displays read-only multi-site enrollment numbers.
Continuing Review, Page 99 for the review of CR for staff now has a uniform template for full board reviews (made to be similar to the UP applications).
Continuing Review, Page 99 now has another option "Approve with Staff Verifiable Contingencies" to choose as a motion for full board review.
Dashboard for "Ancillary Committee" enhanced for users with the "LAC+DHS Administration" roles to streamline ROB Review based on DHS categories (review status demarcated on the dashboard).
New unclaimed studies now will indicate whether sIRB is likely and allow the reliance team to assess whether the study should be reviewed by them. If this occurs, a flag indicating that it is a sIRB study shows up.
A new activity called "Reliance Check" is available to help the reliance team determine whether a study is an sIRB study.
DHS Clearance activity modified to ROB Review which allows staff to modify responses and update the ROB score on a particular study.
"Contract or MCA Consistency Review" is now "Agreement or MCA Review". MCA Review is now separate from the Agreement.
Bug Fixes
"Progress Update Due Date Set" history log on studies fixed - no longer shows on "Modification Open" studies nor on studies with CRs.
"Submit Progress Update" activity for CHLA now shows correct snapshot of questions.
"Submit Progress Update" activity is now hidden until 90 days prior to the due date.
CHLA Final Report Continuing Reviews no longer auto-acknowledged.
Fixed conditional display issues in 6d.1.10.
Fixed an issue that caused applications to be stuck after Cancer Review when no IRBA was assigned.
Fixed an issue that caused Scientific Reviews to show HTML in the History Log.
Monthly Hospital pdf Reports were updated to show the current iStar banner inside the header area.
Enhancements
Created a new section under "PI&Staff" dashboard, "Expiring/Expired" tab to list all the studies that require action as a result of the progress update due date approaching.
Progress Update due dates are now set for all expedited-exempt studies that do not have expiration dates (previously was set based on presence of continuing review).
Updated notifications per institutional requirements regarding guidance on submitting progress updates.
Status flags added to indicate continuing review and amendment status on the main study workspace. Also added flags to both amendment and continuing review to indicate status of the sub-projects.
New notification on PI & Staff dashboard for users assigned to UNKNOWN and CHLA - No Department allowing users to correct their affiliation themselves.
Scientific Review is no longer necessary for Grant/Contract only submissions.
Created infrastructure for Los Angeles General Medical Center Review: Departments, Divisions, and Service Areas review/approve associated protocols in parallel with IRB review. (will not go live on studies until LA General administrators grant clearance)
The PI's Department/Division is added as a required approval.
Service Areas selected in 45b are added as required approvals.
Department/Divisional Review: Added a "Review Not Required" activity. Department/Division reviewers who deem that their approval is not required can run this activity to move the application forward.
CHLA Auditors have access to CHLA Emergency Use/Expanded Access applications and IBC protocols.
Misc
Various miscellaneous bug fixes and enhancements
IACUC
Form Changes
Question 1.7. Text for Biohazardous Materials checkbox updated: Changed "recombinant DNA" to "Recombinant or Synthetic Nucleic Acids"
Species 9.1. Breeding Schema question removed and Species Section 9 re-numbered.
Editorial Change: Species 7.2. question text updated to include chemical hazardous agents.
Surgical Procedures Section 16 Enhancement - "Subcontracted Staff" is now available as one of the options for surgical personnel.
Changes for Committee / Staff
Hide Report Details/Documents from NCR/Monitoring Report/AE: Adjusted the "Convert to NCR" activity allowing the categorization of internal documents/comments vs. report documents/comments. New section to output internal documents and comments on the summary section of adverse events and non-compliance reports (viewable only to IACUC staff and vets).
OOR FY Reporting for Protocols, AM, CR, AE, MR Submitted & Approved Added: IACUC Chair now have access to reporting in the IACUC Chair Dashboard under "Reports"
Monitoring Overhaul: Ability to assign a monitoring reports to multiple protocols
IACUC Member Dashboard: Each respective section now displays up to 25 protocols instead of the previous 10.
OOR FY Reporting for Protocols, AM, CR, AE, MR Submitted & Approved Added: AVP of Research Administration now have access to reporting in the IACUC PI & Staff Dashboard under "Reports"
"Record Meeting Minutes" and "Record IACUC DMR Summary" activities modified to include the ability to specify whether or not monitoring is recommended, its details and species to monitor. If it exists, this information is reflected in the Minutes.
Workflow Update: Amendments can now go through Congruency Review to expedite the approval process.
Added "Convert to Noncompliance" to IACUC AE's "Record Committee Recommendations" activity as one of the Required Action Plan options.
Editorial Fix: Updated "IACUC Adverse Event" project type to "IACUC AE and PAM" to be more accurate when creating new Monitoring Reports.
Various miscellaneous bug fixes including:
Bug Fix: IACUC Agenda/Minutes. 21331-R002 was incorrectly classified under the Non-Compliance Reports section. It is now corrected to be under Monitoring Reports.
Bug Fix: Corrected Approval Dates in the system. Specifically, renewals now have its own approval date and the main protocol does not get overwritten with the renewal's approval date.
Bug Fix: Amendment was not correctly Withdrawn when Main Protocol was Terminated.
Bug Fix: Resolved Internal Server error for IACUC Full Committee Agenda.
IBC
Form Changes
Enhancement: Adding BUA Ready Link for PI Activity/BUA Ready Flag for Personnel to Inform PI when BUA is ready to be submitted.
Section1.13.1 and 13.1.1.1 to capture whether clinical studies utilize an externally administered IBC Committee. Additional status indicator on IBC workspace as well to flag clinical trials that are externally reviewed. Email is sent to relevant staff if 1.13.1 is answered "Yes".
Section 2.10. Waste Disposal wording updated: "Infected animal carcasses" now say "Infected tissues/animal carcasses".
Section 7 (Recombinant or Synthetic Nucleic Acids - Section III Checklist) is now required when questions 1.10.1. or 1.10.3. are answered as "Yes".
14.1. Locations Buildingupdated to include Norris Healthcare Center (HC3).
CHLA Only: Users Agreeing to Participate in a CHLA BUA are required to acknowledge the Hepatitis B recommendation for every new submission, amendment, or renewal.
Changes for Committee / Staff
Various miscellaneous bug fixes including:
Bug Fix: Conditional Display - Followup questions still show up after answering "No" in 1.16
Big Fix: Validation Error section 2.4.2.2 when animals are not involved
RSC
Form Changes
Animal/Human Use of Radionuclide Details now requires personnel to be defined. All questions with the exception of subquestions are now required for these sections.
Other to Administration Staff. Specific adjustment to personnel role to define a person's responsibilities.
Personnel Radiation Handling. 2.1 introduces new question regarding handling of radioactive materials and/or radiation devices. Required for all personnel except RAM Permit Holders (automatically applied) and Administration Staff.
Changes for Committee / Staff
Streamlined Expedited Review to allow RSC Chair and RSO to submit their review along with their vote to agree to Expedited Review
