System Information

IRB

For Emergency Use Applications, selecting "Other HSC locations" in Q1.2.1 will now display a message noting that Arcadia is not an option. (DEV00002432)
For CHLA studies, Questions 25.1 and 25.3 now display an "Other" textbox when "Other" is selected (already appeared for USC). (DEV00002422)
Updated language to qualify what is considered potential conflict of interest (added to page 39 + "Submit Application" activities + "Agree to Participate" activity). (DEV00002444)
Updated Controlled Substances description on 9.2. (DEV00002424)
Emergency Use: The first section (1. Project Info, Drug or Device Name, Treating Physician Info) now restricts users from selecting multiple locations in question 1.2.1. (DEV00002431)
Removed "USC Arcadia Hospital" from selectable locations on Emergency Use Applications. (DEV00002429)

Institutional COI review workflow added to amendment. (DEV00002411)
IRB: The Finalize Consents Activity has been updated to display the current set of stamped consents along with their status (Archived or Open). Additionally, the IRB Archive Consent Documents activity has been integrated here to allow for archiving or restoring documents as needed. (DEV00002450)
User interface for page 39 is now the same as the "Agree to Participate" and "Submit Application" activities. Potential COI question is autofilled to "Yes" if there are entries/selections in either possible conflicts or additional possible conflicts. (DEV00002341)
ClinicalTrials NCI-CTRP Report Request (DEV00002340)
Emergency Use: Added an Other location textbox to section 1.2.1. The new text will appear in section 1.2.2. (DEV00002449)
IRB: A new activity called "IRB Archive Consent Documents" was added to allow users to archive documents so that they are not available to the study team. It will allow users to restore documents when needed so that they are accessible to the study team. (DEV00000602)

Fixed an issue where assigned studies were not appearing correctly in the IRB Committee member inbox. (DEV00002398)
IRB: The "Submit Expedited Exempt Review" activity was fixed and it will show the correct corresponding categories based on the study type. (DEV00002379)
Fixed an issue where question 1.2.1 of Continuing Review was not being displayed properly in the Printer Friendly Version (DEV00002420)
Fixed an issue where questions on page 2 of the continuing review were missing in the Printer Friendly Version. (DEV00002434)

User interface for page 5 is now the same as the "Agree to Participate" and "Submit Application" activities. Potential COI question is autofilled to "Yes" if there are entries/selections in either possible conflicts or additional possible conflicts. (DEV00002385)

Take Ownership activity is now available for IACUC Coordinators to become the Assigned Coordinator for a protocol/amendment/renewal. An Assigned Coordinator column was added to IACUC Coordinator Dashboard to show who has been assigned what. (DEV00002373)
The Send Letter to PI activity for Adverse Events is now available after Recording Minutes (DEV00002327)

For Non Compliance Reports relating to KSOM, an email list is created so certain individuals can be CC'd when memos are sent. (DEV00002402)
The IACUC administrative staff is now referred to as IACUC Coordinator instead of IACUC Specialist in the system. (DEV00002394)
A new role for IACUC Manager & its associated Dashboard was created. (DEV00002370)

Fixed an issue where the "Agree to Participate" activity was not always available on amendments. (DEV00002399)
Updated the email to the PI to be "IACUC AE/PAM Closed" instead of just "IACUC AE Closed" to reduce confusion. (DEV00002426)
Fixed bug where documents inside older History Log entries for NCRs showed only the most recent document. This fix will only apply for new History Log entries from this point forward. (DEV00002380)
Fixed bug where Create Monitoring Report activity also created an empty AE report in Pre Submission simultaneously. (DEV00002427)
Fixed an issue on the IACUC Specialist Dashboard where reviewer statuses were not being displayed properly. (DEV00002433)
Fixed bug where NCR was not being displayed in the NCR section to IACUC Coordinators. (DEV00002392)
In IACUC protocol "5.1 Conflict of Interest", conflict column now accurately reflects when disclosures are attached and whether there exists a potential conflict of interest. (DEV00002425)

IBC

Documentation will be required for externally/commercially reviewed IBC applications (DEV00002255)
Expiration dates for HGT Clinical Trials will be set to one year after approval. (DEV00002363)
Updated BioSafety Sign to reflect the following if BUA indicated as so: AAV, Bacterial Vectors, Other RG1 Viral Vectors, Animal Cell Lines, Working with Live Animals, E-Coli (Both K12- and Non-K!2) under Hosts (DEV00002059)

Add an on Submit validation script to handle items in sections 10 and 11 (DEV00002437)
If investigators select "Yes" for question 1.9 (Animal cell lines, blood, tissue, or other materials), a new icon will appear in the summary section of the BUA workspace page. This icon is represented by a blood drop and a mouse symbol. (DEV00001834)

RSC

In P1.1, question 2 is now required and has changed to a dropdown selection list for physical form. Added required follow up questions for whether it is sealed source or volatile. (DEV00002377)

If a user had previously attached an IACUC protocol under Section 1.5 in an "Experiments in Animals" application, and then switched the submission type to some other type, the attached protocol(s) is now removed from the saved field. (DEV00002389)

Users no longer are required to submit 1 research-related admin per HD1.2 entry. (DEV00002375)
Fixed a bug in RSC Staff Dashboard where certain RUAs were not appearing in the Unassigned RUAs section. (DEV00002439)