Updated to the newest version of Click Portal, 8.1.5.
Status Indicators for Amendments/Renewals (AM/CR Opened column) in All Studies/Protocols/BUAs/RUAs have an updated look
Support Site Changes
Log Comment updated to add attachments and have it be reflected in History Log
Close Issue now sends email containing comments recorded inside activity
Record Validation Results; Record Meeting Minutes; and Update Development Statusadded checkbox to copy the motion comments to the History Log
IRB Changes
Form Changes
Page 1: 1.1 changing submission type from ceded removes the ceded category from review type as well
Page 2: Key personnel guidance added
Page 6a: Roski Eye Institute and HCC 1 or 2 have been removed as options for HSC locations. They are part of the Keck Hospital of USC Facilities
Page 6d: 1.4.3 changed "Patient" to "Participant"
Page 13: No longer wipes out target accrual (bug fix)
Page 24: For USC, added a link to the Informed consent template
Page 24: Electronic consent warning shows at 24.8
Status Indicators under Summary Box now have an updated look
Adverse Event Review completely rewritten using current frameworks
Committee member review of reportable events no longer have the options to indicate that it is continuing non-compliance or an unanticipated problem. Those are full committee decisions
Flex category changed - only one category option now
New Rule status shows on the workspace
New Rule status options show on staff review
IRB Analysts can now add a Participant or Other Compliant into the system. Prior to this only the IRB directors and chairs could do this.
For CHLA, volunteers are no longer barred from being added with the Edit Study activity.
HIPAA Forms link by approved documents fixed
CHLA can attached IBC applications to their studies
Copying study will now remove the OnCore information from the copy
Emergency use/expanded access section: submit activity now reflects type of submission
Review time for Amendments and Continuing Reviews will now be calculated on approval
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
Status Indicators under Summary Box now have an updated look
Designed for Monitoring information appearing under the Summary Box now have an updated look
Species section 10 is now called "Drug, Chemical, and Cell Treatments". Question 10.1. instructions were also updated tp reflect the addition of "cell treatments"
Species 2.3 questionwording updated
Protocol 1.7. question now appears when submission type selected is either New Protocol or Competitive Renewal
Staff
Pre-Review DMR process added to the workflow to assign protocols with this new process for Pre-Review Meetings
Indicators for Protocols assigned to Pre-Review DMR was added to Printer Friendly Agenda, Printer Friendly Minutes, and Project workspace
Assign for Pre-Review & Schedule and Reschedule Pre-Review was updated to indicate whether or not a protocol should utilize the Pre-Review DMR process
Send Pre-Review Email activity was added to Meeting workspace for IACUC staff to send off an email containing all the protocols scheduled for the next Pre-Review meeting to all IACUC Members
IACUC Member Dashboard updated so members assigned to Pre-Review DMR will have an indicator icon to review if assigned
Submit IBC Review & Submit RSC Review now have previews that reflect the new Status Indicators found under Summary Box
Send IACUC Message is now reformatted for the History Log to show recipients
Resend Reminder to DMR emails will now only go to members who have not voted yet and members can only cast their vote once
Non Compliance Reports now have the ability to add Staff Review and also Proposed Motion when recording Minutes. These fields were also added to the Agenda/Minutes.
Monthly PAM Reportsupdated to include Competitive Renewals and removed reports that have been withdrawn
Submit Review has been updated with new logic when displaying the Monitoring information to ensure all monitoring reports are displayed
System Emailsupdated headers to include full protocol information including: protocol title, PI name, and number.
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Question 1.3. wording updated to reflect the information for CHLA personnel training
Question 1.5. wording updated to "Toxins of Biological Origin"; Section 8 was updated accordingly
Question 1.7. wording updated to remove Select Agents and renamed the list as "DURC List"
Question for Clinical Trials now moved to 1.13. as its own separate question
Questions 2.3. Biosafety Practices for USC was updated to be a number of questions instead of a general textbox
Staff
Administrative Review process for CHLAadded to the workflow so that the administrator can approve minor amendments
Approval Letter Templates for USC now only contains the "Master" templates
Splitting of Administrative Expedited Reviews from Non-Administrative for USC for Printer Friendly Agenda
The ability to specify whether or not an application is Administrative Review can now be done in: Assign Specialist; Forward for Expedited Review; and Update Minutes Summary
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Compound to H1.2. section added to where Radioactive Materials are done with Research with Humans, Compound is now required when a Radionuclide is specified.
Question 7 (Primary Critical Organ) and Question 8 (Dose to Primary Critical Organ) are removed from Radiation Dosimetry section
Animal Information Question 2wording updated where Radioactive Materials are done with Experiments with Animals, question 2 is now changed to "Chemical/Compound"
Staff
Expedited Review processadded to the workflow so the process can be captured more formally in the system
Initial Request for Expedited Review needs to be approved by RSO and the Chair before it can be brought the committee for consideration. If the committee decides to proceed with Expedited Review, then reviewers are assigned.
