The following system changes may impact Core Staff users:
- Submission Review creation is now split into two processes to assist in system performance. The Reviewer Checklist is created when user first accesses the Review Checklist by clicking the Edit Reviewer Checklist button. If the reviewer doesn't access that view on the day when the review is created, the checklist will be created automatically during nightly processing.
- Core Staff will be able to check the "Review Study Team Changes" checkbox in the Full Committee activity to send the reviews back to the reviewer. The Review will change from a state of “Submitted” to “Review Study Team Changes” if the checkbox is checked. This option accommodates “Action Deferred to Study Team“ determinations by the board that need to be re-reviewed.
- For offices interested in publishing reviews for Study Team view, the ability to publish the Staff Review has been added to the following activities:
- Application - Approve, Approve with Contingencies, Action Deferred Pending study Team, Disapproved Final
- Amendment - Approve, Approve with Contingencies, Action Deferred Pending Study Team, Disapproved Final
- Adverse Event – Approve
- Continuing Review - Approve, Disapproved Final