Dashboards for PI&Staff and IACUC PI&Staff are re-imagined. Inbox now only show relevant items that require attention and alert boxes are displayed to show important system messages or expiring/expired training.
IRB
Form Changes
Section 4.4, 17.1.2, and 18.1.8 have been redesigned for integration with the new diSClose system. Users will need to indicate whether the sponsor is an individual or organization. If it is an organization, the user will need to find it in the selection field. Otherwise, there will be an option for write-in entity.
Section 5C.2 on coded studies has been slightly modified to be more intuitive.
The option to select "Military Personnel" from Section 22 is no longer contingent on selecting "DoD Funding" on Section 4.
Amendments:
(USC) Amendment Information Section: New Simple Amendment question added AM1.7. This allows the study team to request simple amendment prioritization.
(USC) If the study team indicates Yes to AM1.7., a new Simple Amendment status bubble will appear in the workspace summary area after the amendment is submitted to the IRB for review.
(USC) Added new functionality to allow IRBAs to remove Simple Amendment prioritization via the Send Message to Investigators activity; this can be utilized if the amendment does not meet requirements stipulated by the IRB submission guidelines.
(USC) The following question will show on the Send Message to Investigators activity if a simple amendment was requested in AM1.7: "Does simple amendment priority status still apply?" If No is indicated, the Simple Amendment status will be removed after the form is submitted and the amendment will get placed back into the normal queue.
(USC) After the simple amendment prioritization is removed, it will get reflected in the amendment history log.
IRBA Dashboards (USC only):
IRB Administrator2: Amendments assigned to the IRBA are now listed separately under the My Inbox tab and includes an "Amendments" heading; any Simple Amendments will appear at the top of this new section. This new area is followed by the existing projects list which now includes an "All Projects" heading. The list under the Amendments Inbox tab was also modified to show Simple Amendments at the top.
IRB Administrator: Amendments assigned to the IRBA are now listed separately under the My Inbox tab and includes an "Amendments" heading; any Simple Amendments will appear at the top of this new section; it is followed by the existing projects list which now includes an "All Projects" heading.
Bug Fixes
BUAs now link properly on Section 11 of coded studies. IRBA can access it appropriately during review.
Automated attendance request emails on committees are no longer blank.
(USC) Section 25 Financial Obligation and Compensation: Section 25.3 now will not show if the study application is not fullboard and not Ceded (exception for SB submissions was removed).
(USC) Section 25 Financial Obligation and Compensation: The Cost and Injury (25.1.A and 25.3.A) sections now show the choices selected in 25.1 and 25.3 respectively on Ceded studies.
Enhancements
Beta versions of the IRBA and IRB Director Dashboards were released
IRBAs can now assign studies to either BioIRB or SBIRB committees regardless of campus of submission.
(USC) Amendments are now required to add co-investigators. Users will be unable to use "Edit Study Personnel" activity or Section 2.1 to add co-investigators outside of pre-submission/amendments.
(USC) The "Forward to "Expedited-Exempt" activity now includes DoD checklist templates.
(USC) Staff reviewer form on continuing review now contains reportable events from the "Protocol Change initiated to Eliminate Immediate Hazard" category.
Updated the language for section 6d.1.6.3
(CHLA) Hid sections 2a and 35 for new ceded applications
Hid section 9.1.1 from all users since EH&S sign-off is no longer required for in-person community based research and KSOM has disabled their C-19 portal
9.3 will now determine whether the GCP is required or not for full board and ceded studies
(USC) The COI section will now appear on Ceded studies regardless of whether informed consent will be obtained as conflict of interest review is required on all submission types.
(USC) Ceded Applications: A new question was added under D1.5.1. where the study team can indicate whether or not research will be conducted at HSC. If they indicate Yes to D1.5.1.a "Will any study activities occur at any HSC Location(s)?", section D06a. HSC Location(s) will show in the application.
(USC) Ceded Applications: Editorial changes were made to the following items at D1.5.; these are highlited in bold:
D1.5. Which study activities occur at USC or affiliated/non-USC sites?
D1.5.1. Will participants' informed consent be obtained at USC or by USC study personnel?
D1.5.2. Will identifiable data or information about the research participants solely for the purposes of the research project be obtained at USC or by USC study personnel?
D1.5.3. Will interaction or intervention with research participants occur at USC or by USC study personnel?
Misc
IACUC
Changes for PI / Study Team
Application
All personnel handling animals with the exception of the PI will now have to provide an e-signature by running the “Agree to Participate” activity in New Protocol and Third Year Renewal submissions. A 24-Hour Contact Number is also required as well. A new activity called “Send E-Signature Required Notification” will notify all personnel who haven’t signed off to do when run.
New questions (1.5.1. - 1.5.8.) were added in Protocol Section 1 related to Funding to align with the questions asked in IRB Studies. NIH and USDA removed their requirements for annual renewals so an additional question was added to determine whether or not annual renewal is required for a particular protocol.
New questions (7.5. - 7.10.) were added in Species Section 7 for Biohazardous Materials about what hazardous substance will be used. Based on the answers, a “Special IBC Procedures/Labeling” status indicator would appear under the Summary box and also as a tab in the main workspace
New species were added/updated:
Bearded Dragon
Giant Sea Bass
Bocaccio
Tree Fish
Yellow Tail
Sheep
Robust Capuchin
Bobwhite Quail
Valley Quail
Gekko Gecko
Eyelash Leaf-Tailed Gecko
Cork Bark Leaf-Tailed Gecko
Green Tree Frog
Mossy Leaf-Tailed Gecko
Mossy Gecko changed to Mossy Prehensile-Tailed Gecko
IACUC PI & Staff Dashboard
Added Alert Box for No ARA on File or ARA Expiring in 90 days
My Inbox: Added IBC BUAs: Response Required;RSC RUAs: Response Required; No Pending Items
Pre Submission: Added E-Signature Status for IACUC & IBC
IACUC Protocols: Added Protocol Flags to inform the PI of things they should be aware of for a specific protocol; Species is now a searchable field in the Filter By search box.
Main Project Workspace
Status Indicators under the Summary Box now also indicate whether or not a renewal is needed within 90 days and whether or not it is going to expire within 90 days or whether a protocol no longer needs an annual renewal
Authorized Submitters are now displayed in “Researchers” tab under the Summary Box; 24-Hour Number and Sign Off Status is also added to the Researchers section.
Changes for IACUC Committee / Staff
IACUC Specialist Dashboard
My Inbox: Added Protocol Flags and Assigned Reviewers, along with status indicators for the respective items that were outputted
IACUC Member Dashboard
My Inbox: My Review Status was modified so that it will turn red if no review has been submitted after 3 days
Various sections of the Dashboard now only displays specific IACUC Protocols/BUAs/RUAs that the Committee Member is a personnel in instead of everything they have access to
IACUC Chair Dashboard
My Inbox: Columns for Assigned Reviewers and External Funding were added
Various sections of the Dashboard now only displays specific IACUC Protocols/BUAs/RUAs that the Chair is a part of.
Veterinarian Dashboard
Content Management tab was added for Vets edit the Anesthetics/Analgesics found in Pain & Discomfort section of the application
Meeting
Removed the text "Respectfully submitted by ---" for the committee meeting minutes as it was generating "NULL" for the person
Submit IBC Review activity: Added Project Summary and Species/Hazardous Substances Used
IACUC Specialists now get an email notification when all DMR Reviewers submitted their reviews.
Reports - IACUC Semi-Annual Inspection - Added Cost Center Name; Cost Center Name Level 5, Home Department and Home Division from Shib
Various miscellaneous bug fixes and enhancements
IBC
Changes for PI / Study Team
IACUC PI & Staff Dashboard
Added Alert Box for IBC Training Expired or Expiring in 90 Days
Main Project Workspace
Added Status Indicators under Project Summary
Changes for IBC Committee / Staff
IBC Staff Dashboard
Moved Upcoming Meeting to the top of the page
My Inbox: Added a column for Protocol Flags that outputs useful information for reviewer; Added a new section for Pending Changes by PI and a new section for Assigned to Meeting / Contingency Review / Expedited Review / DMR that have information of who all the Assigned Reviewers are.
Content Management tab was added for staff to edit the Special Handling/Labeling Instructions found in Biohazardous Materials section (Species Section 7) of the IACUC application
IBC Member Dashboard
My Inbox: Added My Review Status column to easily distinguish if someone has been assigned to review and what the status of it is.
Reports: Modified IACUC Activities by IBC Reviewers section tiles to be activities within the last 90 days to be more useful. Specific date ranges can be run by utilizing the “Change Parameters” feature under the “Actions” menu.
IBC Chair Dashboard
My Inbox: Added My Review Status and Assigned Reviewers columns
Various miscellaneous bug fixes and enhancements
RSC
Changes for PI / Study Team
Questions 1.6.1. - 1.6.3. was updated to ask for "specific page numbers" instead of "specific sections"
Question H2.4. was updated with bullet points for clarification
Changes for RSC Committee / Staff
Expedited Review has been enhanced to remove a duplicate step where the Chair and RSO have to Agree to Expedited Review a second time.
Request Expedited Review activity email subject line and header renamed to "Request to Agree to an Expedited Review" to lessen confusion
Expedited Review: Pending Confirmation and Expedited Review: Pending Confirmation from Committee states now contain the Assign to Committee Meeting activity so it can be assigned to committee member by a specialist if need be
