Updated to the newest version of Click Portal, 8.1.3
IRB Changes
Ceded Review Form Changes
1.1 Option Changed from "Ceded Review (Utilize approval by an outside IRB)" to "Rely on another IRB (Ceded)"
1.1 yellow "helper" text for ceded removed
1.5 for CHLA, provide link to CHLA's ceded checklist
Page 4: Remove 4.2-4.5 inclusive
D1: D1.1 - remove cedars as an option, rename StrokeNet to University of Cincinnati
D1: D1.2 - question reworded
D1: D1.3 - question moved to D1.3 from D1.4.5
D1: D1.3 - renumbered to 1.4, "Employees" changes to "Personnel"
D1: Yellow helper box removed
D2: D2.1 - For CHLA, blood collection option added, with assurance language to show up if checked
D2: D2.1.1 to D2.1.4 inclusive, removed
D2: D2.2 For CHLA, added checkbox for minors
Page 10: added for CHLA
Page 24: For CHLA, 27.2 and 27.1.2 added
Page 24: 24.7 reworded, link to CHLA's checklist added
Page 26: Added for CHLA, only questions 26.3 and 26.4
Page 35: Question added for USC, "Will the IRB of record act as the HIPAA Privacy Board for this study?" if answered yes, then the remaining HIPAA questions are skipped
Page 40: Removed for USC
Form Changes
Page 1: Ceded option altered to say: "Rely on Another IRB (Ceded)"
Page 4: If Department funds are selected, 4.1.3 appears and asks for the account name and number
Page 6c: 6c1 will now warn for GDPR if study will occur within the European Community
Page 9: if Pathology is involved, then for CHLA ask for letter of support from laboratory
Page 18: 18.1 has supplemental questions for the USC Keck and Norris hospitals for devices
Page 24: Warning about GDPR will appear if EC site is added at 6c1
Algorithm for determining require Dept/DIv for review has been modified to help counteract false positives
GDPR support: If a study is going to be performed in Europe, the system will now correctly warn them that they will be subject to GDPR and will require consent language that complies with the GDPR regulations
For studies where HIPAA applies, the approved documents sections will remind the study team that they must provide HIPAA documents as well
For CHLA, when Pathology is involved, the study team will be prompted to attach a letter of support from the laboratory
For CHLA, all enrollment status changes now require an amendment
Expanded Access applications are now available for UPC
Expanded Access applications will use an "EA" prefix instead of "EUA"
Reviewer page has been corrected to have the correct review category
Amendments with pending Independent Investigator agreements can no longer be approved until the IIA is signed
UPC letter templates corrected to have the funding details show up in the correct place
Various miscellaneous bug fixes and enhancements
IACUC Changes
Form Changes
When deleting species, there is now a confirmation box to confirm the action before proceeding
Species Section 18 is now removed; 18.1 now appears as 10.2.1. if 10.2. is answered as Yes. Text for 10.1. has been updated.
Authorized Submitters can now request reactivation.
Staff
Submit Review:Comments requiring response and Comments not requiring response textboxes are now switched locations
Agenda: Monitoring Reports now have PI Name
Record Meeting Results and Request Chair Confirmation: Updated to new look and feel with accordian
"Resend Reminder to DMR" activity now contains a confirmation before activity is executed
NCRs can now be removed from a meeting agenda
Various miscellaneous bug fixes and enhancements
IBC Changes
Form Changes
Anyone in the Personnel list can now withdraw the application in Pre-Submission.
Section 3 was reorganized so that AAV is now its own question instead of residing inside of the "Other Viral Vectors" section. Previously entered AAV inside the "Other Viral Vectors" section would remain in that section.
IBC Training for CHLA is now reflected in the user's iStar profile and in the Personnel section
Staff
IBC Staff can make minor edits such as spelling corrections to applications.
IBC Staff for CHLA can now update training in user profiles.
Various miscellaneous bug fixes and enhancements
RSC Changes
Form Changes
Anyone in the Personnel list can now withdraw the application in Pre-Submission.
When the main RUA is withdrawn, any open AM/CR will now be automatically withdrawn by the system.
A link to Dose Calculator was added above Section 9: Primary Critical Organ in Radioactive Materials
Staff
Agenda: A new permanent Agenda Item called "MIC Report" was added after RSO Report
