Retooled Conflict of Interest functionality to better ensure that the COI committees are informed, can access, and are able to review cases of possible conflict of Interest. This includes better emails, Amendments being included as available for COI review, having the emails sent out any time a possible conflict is indicated (not jsut at initial submission) and making the COI emails go to a set of people defined by role instead of individually.
Ancillary committee functionality has been completely rewritten to provide consistency and a more accurate account of which ancillary committees require viewing access to studies.
When a study, amendment, or continuing review is approved, the snapshot of the forms that is taken upon approval will be available as the printer-friendly view.
UPC Dornsife imaging center studies have an additional attestation within the study form.
Flex policy information is available on the summary information for studies, continuing reviews, and amendments.
Approve activity for Continuing Reviews and Amendments works the same as for studies now with increased control of who gets emailed and what.
New close study action available for studies that are exempt - no need to leave them open or to submit a continuing review to close.
State transitions continue to be reworked to eliminate complexity and become more consistent.
People who are added as a "Guest" on a study (given read only access) will automatically be given the "guest" user role so that they are able to see the study. Previously, this would have to be added manually by iStar support.
Incidental findings show up properly on the CR workflow
A number of display and functionality driven bugs have been addressed for the CR IRB workflow
IRB Approval criteria have been added to the IRB determination pages for continuing review.
Study and Clinical Trial Linking functionality between iStar and TRUE2 has been significantly improved.
Ajax activities functionality has been improved to fix bugs and be more available to IRB staff and chairs.
Originally approved version link on the Amendment now points to the snapshot (if there is one - else to the copied protocol (old method)).
Changes to AE workflow pages (1)consent form and (2)anticipated event exceeding protocol
Continuing Review pages link to study (top grey bar)
Attestation for PIs has an added line regarding COI (added for the forms in June but officially here)
IACUC initial development is included into iStar. This includes a large number of forms and other necessary workflow items.
Required Division/Department approval functionality has been completely rewritten to increase consistency and accuracy.
A number of automated statistics and reports have been created.
A number of message templates have been altered and/or created for the IRB.
Retrospective studies now will ask about and capture vulnerable population information.
All type of submissions will get the same dept/div sign off page(excepting UPC). This eliminates duplication and creates a more consistent and maintainable dept/div review page.
Upon the submission of a serious, unexpected and possibly related reportable event, the CTU office will get an email notice for studies conducted through their facility.
Fixed a code bug related to the activity that sends out the "All Co-Investigators Have Agreed to Participate" notice to the study team.
Modified the state transitions for Studies, Amendments and Continuing Reviews which will prevent edit access by the study team once the project has been submitted to the IRB.
Fixed a code bug related to the Drug Entry Pop-up window (section 17.1) which would show a false validation error for uploaded documents.
Added fields into person profile for GCP document and GCP completion date.
New function for IRB Directors to choose the review method on Continuing Review
The workflow for retrospective expedited studies has been altered to include special subject populations.
