The Orders Management Project (OMP) has been integrated with eResearch. The OMP is a Health System project for online management of orders for medication, lab tests, and x-rays. Question 14.1 regarding UM facilities includes new facility options, some of which participate in the OMP. Selecting one or more participating facilities will redirect the user to a page with a link to the OMP website and contact information.
Questions in sections 21, Ionizing Radiation, and 21-1, 21-2, and 21-3, RDRC/SHUR Information, have been expanded to include more clarifying text.
Section 21-2 now includes a new required question, 21-2.4.1, regarding the source of preclinical toxicology studies. If an application was submitted prior to this change, study teams will be required to answer this question if any other changes are requested to the application.
Section 25-3.3 now includes a link to the Data Use Agreement form for the UMHS Privacy Board.
The IND (Investigational New Drug) number now displays in the table in sections 15.3.1 and 15.3.14.
Pending contingencies can now be viewed under the Pending Contingencies tab in the Adverse Event workspace.
Core Staff Functionality
Expedited categories have been updated to match the current regulations. For more information, refer to the OHRP website.
Amendments in the states In Administrative Review and Validate Administrative Review now appear in the core committee staff inbox.
Continuing Reviews in the states In Administrative Review and Validate Administrative Decision now appear in the core committee staff inbox.
In the Full Committee and Edit Agenda Information activities, users may now select conflicted committee members from a list of all users in the system.
For regulatory reasons, the states and activities for Adverse Events that previously used the term "Expedited Review" are renamed "Single Member Review."
The Issue Ancillary Committee Approval and No Review Requested activities now display an error message if the user does not select the ancillary committee.
The No Review Required activity now displays an error message if the study team has not submitted changes requested by that ancillary committee.