Scheduled release date: Monday, March 29, 2010
Release 2.3 system outage information:
5 pm Friday, March 26 through 6 am, Monday, March 29
For a listing of all changes included in the release, refer to the release notes
CRAO (formerly CRBU - Clinical Research Billing Unit) is now an ancillary committee
Submissions that require review by CRAO (Clinical Research Calendar Review and Analysis office) will be routed to CRAO in the Ancillary Committee review process.
Amendment flag for Cooperative Groups/Consortiums
A new question (1.7 Is this amendment issued by a National Cancer Institute (NCI) sponsored Cooperative Group/Consortium requiring IRB approval within 90 days of distribution?) has been added to the amendment cover sheet so study teams can flag these types of amendments.
Amendments with this flag will appear in all reviewing committee workspaces in red font and will be marked Y in the new Is Urgent? column.
Additional values have been added to 13.1 (Cash and Check are separate values, and Visa Gift Card (HSIP issued) and Payment Voucher have been added). Study teams that previously selected Cash/Check in 13.1 will have both Cash and Check selected in 13.1.
The system tier calculation rules and the staff Change Tier activity have been updated.
Sections 7, 15, 16 Drug and Device Updates
Updates have been made to sections 7, 15, & 16 to better facilitate studies under FDA review.
Staff and primary reviewers have a new question (is this FDA regulated?) that will conditionally display on the final page of the Staff and Primary Reviewer checklist.
A new role has been created to provide view access to submissions for persons with regulatory oversight responsibilities.
IBC registration review process updated
For staff and reviewers, the registration review process has been updated.