IRB/EC Settings

The IRB/EC organizations associated with the study will normally be identified and configured upon room creation. However, additional IRB/EC organizations can be added, edited, or deleted as needed from this menu.

In order to add a new entry, use either the ‘Add’ or ‘Addexisting’ buttons. The ‘Add Existing’ button opens a list of organizations stored at a domain level. Locate the appropriate organization and press the OK button to add them to the room list.

The ‘Add’ button opens an interface for creating a new entry. Complete all required fields, as well as any available optional information, and press OK to create the new record in the room list. Some of the more advanced predictive reporting features of Study Start-Up are dependent upon the non-required fields listed in the window as they allow the room to predict site activation based on the approval cycle, buffer time, etc., associated with the approving organization.