Integration between COI system (diSClose) and USC IRB applications (on page 39)
IRB Application Form Changes
Page 6: item 6.1 edited, item 6.3 split into two questions, now under 6.2 as 6.2.1 and 6.2.2
Page 9: GWAS has place for upload of institutional official letter
Page 9: Biohazardous Substances option altered
Page 17: For studies that include LAC+USC, additional question as to whether the study drug will be provided and if not whether it is on formulary for LAC+USC.
Page 22e (Minors) now is required for retrospective expedited studies
Page 39: this page was altered to clear a "yes" answer to 39.3.1 if the user indicates "no" to question 39.3. This was reported as a bug.
Study Enrollment Status now captured on the study itself, not just Continuing Review.
Activity to alter enrollment status available on study
Enrollment status can be altered on Amendment (page 1) with an explanation
Immediate Hazard warning shows up on amendments that check off that there is a protocol or risk change
Suspensions are now only available to be performed via a reportable event
Suspensions can be lifted by a determination on a reportable event or on an amendment
Withdraw activities for the IRB have been created for Continuing Review, Amendment, and Reportable Event
Renewal and Past Due messages redesigned for UPIRB
Committee Member Review page for Reportable Event altered to fix a number of display bugs
Criteria for approval available for all expedited reviews
Study closure status on Continuing Review edited to make clear that study records may be kept
Three minor editorial changes were made on the continuing review committee minutes review page (data formatting and misspelling corrected)
Reminders reworked with new architecture to improve the efficiency of the reminder notices
Modified the "Submit Contingency Review Findings" activity to use the correct auto-populate language when the reviewer chooses the "Approve with contingencies Designated Reviewer" motion. This was reported as a bug.
Added the "New Continuing Review" button to HUD (Humanitarian Use Device) studies; these types of submissions are eligible for continuing reviews. This was reported as a bug.
For Continuing Reviews of a study that is closing, reviews follow the same smartform as the application and no longer require answers for questions that are not relevant.
Approval date gets automatically populated on expedited reviews.
IACUC Changes
Integration between COI system (diSClose) and USC IACUC applications (on page 5)
Home pages for IACUC coordinators, committee members and chairs have been significantly reworked to organize work items.
Text changes to a few questions on page 1 of species
Review assignment bug fixed
Attached IBC and RSC applications now show on the related species pages
Copy protocol activity disabled on amendments and renewals
Education agenda item type removed. "Non Compliance Report" added to the set
Monitoring has new description field
Renewal notifications no longer continue after renewal has been submitted
Renewal due notification added at 90 days before expiration
Added Internal Notes for User profiles
Animal Numbers are now automatically calculated for strains
Fixed the form for "Terminate" activity
Reminder notifications are now sent to PIs to respond to stipulations and for Committee Members to submit a review for DMRs
IBC Changes
Updated validation for page 12 from having textboxes required to have the checkbox selection required
IBC staff inbox fixed to show current data
Send BUA ready notification bug fixed
Amendment approval "access denied" issue resolved
Reminder notifications are now sent to PIs to respond to stipulations
RSC Changes
Fixed show/hide bug involving IRB and IACUC selection
Added Question 1.2, Project Title
Added "Co Investigator" role to Personnel
Added "Informed Consent" as a Document Type (on page 3)
"Experiments with Humans" is now changed to "Research with Humans"
Emergency Use Changes
IRB Chair Concurrence letter activity altered to give chair complete control of letter
Re-Issue concurrence letter activity added
General Changes
New users will receive notification that they successfully registered with the iStar system
The footer has been updated to reflect the name change for CHLA's IRB and to add reference to IACUC and environmental health and safety
