Page 1: For USC studies, if an institutional conflict of interest (1.6) is indicated, a warning is given notifying the study team to contact the USC Office of Compliance
Page 2: Faculty Advisor Box has been converted to show/hide based on whether or not a Faculty Advisor needs to be designated for the study
Page 4: The funding page now updated to show item 4.5 when subcontract is selection in section 4.1
Page 5: Q 5.2 has been edited slightly to avoid misunderstanding
Page 5a and 5b: retrospective research will be able to indicate the query ID if the clinical data warehouse will be used
Page 6: Exempt studies at CHLA will be required to complete page 6d when other sites are involved
Page 9: New Question: 9.2 Is this study a clinical trial
Page 9: Warning that study staff need GCP and must be registered on clinicaltrials.gov if clinical trial (9.2) is answered affirmatively
Page 9: Rewording of investigator initiated question 9.3
Page 9: UPC no longer gets Q 9.3 (investigator initiated)
Page 9: "GWAS" references replaced with "GDS"
Page 22: exempt studies at UPC that indicate employees or students will be part of the participant population will have to complete page 22b
Page 24: For HSC Full Board studies, 24.1.2 no longer is displayed
Page 24: new option for choosing the clinical data warehouse at 24.1
Page 26: Question 26.4, "Will identified" was changed to "Will coded or identified" for CHLA
Page 41: new page for information required by the scientific review committee. The page has four questions on feasibility.
Ceded Page D1: D1.1 edited to allow for the possibility that the ceded application is being submitted prior to approval by the external IRB
Ceded Page D1: D1.1 options edited to include WIRB, UCLA, and StrokeNet as possible IRBs to select.
Ceded Applications now get Page 25 (Cost and injury)
Ceded Page D2: Adults not competent to consent on D2.2 gets Page D22c (same as page 22c on main application)
Ceded Page D2: Radiation exposure now allows the RSC application to be attached in D2.3
New Scientific Review ancillary committee functionality: If an application is submitted to USC, is a clinical trial, has not undergone prior scientific review, and (for HSC) is investigator initiated, the application will be routed for scientific review prior to being seen by the IRB.
Reviewer Notes functionality added for UPC and HSC, expedited review and lower only. This allows contingencies to be created and answered on specific pages of the study application. Each contingency must be answered individually.
Current Human Subjects training for study staff is now required for Amendment/Continuing Review submissions
CTO checklist activity on Amendment altered to work like the one on Study
"Suggest Identifier" button was added for Continuing Reviews to generate a name for the submission, assuming Study Status has been answered
Co-Investigators can now be removed via the Edit Study Personnel activity
Bug where abstract would occasionally disappear in the AM/CR is now fixed
Approve activity: "Can the Study Begin?" question is now required
The messages related to Emergency Use applications will now route to the director and chair when the treating physicians submits a response to the IRB.
Submit Expedited/Exempt Review for Coded now pulls from 5c
Capture the DHS Level of Approval for LAC+USC Research Studies on Expedited Review.
Expiration dates are no longer required for ceded or not engaged studies
Adjust Approval/Expiration dates activity now does not require expiration dates unless the study is expedited or full board
"Return to Presubmission" activity now correctly restored original APP ID number to study
Continuing Reviews no longer ask conflict of interest questions. Form will show what has been previously disclosed and ask that an amendment be created if a change must be made
CRs are now showing up correctly on Study Status and Enrollment (page 2) of the IRB Staff Review page
LAC+USC email notices now utilizes a custom search in lieu of specific user/recipients
Once LAC+USC auto clears the study, DHS notices are now sent
The IRB and the PI now have the ability to withdraw NHSR applications
Federal funding was added to the list of funding categories in the NHSR application and the title is editable
New page template created for NHSR applications
New personal page created for CTO; auto assignment and email to CTO Teams based on department
Flag that a study needs review by CTO was altered to support OnCore
Ceded review studies now will be "acknowledged" rather than "approved" by the IRB
If a conflict was indicated on the Submit or Agree to Participate activity, the conflicts needs to be set on the respective individual
For amendments, a new enrollment status is now required if Enrollment Status Change was indicated
OnCore activities are available only to studies that are not UPC. Also, it is only available in states with the Study Team and not Pre Submission.
A column indicating whether or not a “AM/CR Opened” was added to the Approved, Exempt, and All Studies sections
Removed restriction on approve activity that did not allow it to show up unless a vice chair had seen the contingencies. There were many occasions where this was going awry.
On continuing review, the subjects Enrolled Since Last Report, Total Enrollment Since Initiation, Adjusted Target Accrual, Target Accrual, and the number of future subjects allowed fields are no longer required for HUD (Humanitarian Use Device) applications.
New activity created for Amendments: "Send Faculty Advisor Instructions"
Various changes to form validation requirements
Various miscellaneous bug fixes
IACUC Changes
Third Year/Annual Renewal Notification upon AM/CR creation
Submit IBC/RSC Review activities now have a preview of determination feature to reduce error
IBC/RSC Yellow flags logic updated to more accurately reflect whether or not there might be changes by PI requiring additional review
Protocol 1.7 and Species 3.4 are now required
Species 1.7 Procedures unselected values are now displayed in Printer Friendly view, section numbers are now appended to the end of the respective procedures for more clarification
PIs are now automatically notified their protocols are designated for monitoring upon protocol approval; updates were done to check and uncheck notifications when monitoring is designated and when monitoring status is edited by staff
Added Log Comment and Complete activity forms to Non Compliance Reports
Non Compliance Reports can now be assigned to meetings in the Meeting Completed: Awaiting Correspondence state
When no procedures and animals are housed at USC is indicated in Question 1.7 of the main protocol form, IBC and RSC Required flags are now automatically set to false
Fixes were made to the approval and renewal date calculations
PIs can now submit their protocols on Page 99. "Instructions for Submission"
Various enhancements to the Committee Meeting agenda and minutes
Various miscellaneous bug fixes
IBC Changes
Question 1.2.8. regarding Human Fetal Tissue was added
The option to Disapprove has been added so BUAs can go to the state of Approval Withheld
Send to Expedited Review is now available in the Staff Review and Bio Safety Specialist Review states
Record Meeting Results and Request Chair Confirmation activity is now available to IBC Staff
Request Changes email template updated to minimize confusion
Items are now automatically archived after 90 days and if archived, PIs can return the application to Pre-Submission to continue working on it; Email Reminders are sent in 30, 60, 90 days intervals to PI and Study Contact
New approval email template was added for IACUC Protocols
Various miscellaneous bug fixes
RSC Changes
Users are able to designate non-board certified personnel in HD1.2 for DEXA procedures
Users can now send Study Ready Notifications so the PI is alerted that the application is ready for submission
The staff now have the ability to re-issue approval letters
The option to Disapprove has been added so RUAs can go to the state of Approval Withheld
Items are now automatically archived after 90 days and if archived, PIs can return the application to Pre-Submission to continue working on it; Email Reminders are sent in 30, 60, 90 days intervals to PI and Study Contact
