Roadmap: Configuring corrections to subject information

This roadmap describes the typical process of configuring edits to subject information, including the approval cycle set up by the sponsor. The way these systems operate can vary from study to study, so be sure to check with the Field Monitor for your study for exact details.

Step #	Action	Menu to select	What happens?
1	Determine which fields a user should be able to edit	N/A	This collaborative effort between Oracle and the sponsor is completed during the design phase of the study.
2	Identify editable fields in AppBlock Designer	N/A	An Oracle representative must perform this task during study design using an internal tool called the AppBlock Designer.
3	Configure out-of-age approvals in the Config Tool	N/A	An Oracle representative must perform this task during study design using an internal tool called the Config Tool.
4	Authorize the type of edits that are permitted: Subject data edits Drug reallocation Visit rollbacks	Configuration General Configurations Transaction Configurations	Each type of change must be: Authorized–switched on in IRT. Configured–set up to work properly for your study (for example, set the roles that can approve or reject a request.
5	Enable editing and assign permissions for each editable field	Configuration Transaction Configurations	If subject data edits have been authorized, you can: Set the roles whose assigned users should review changes to each field. Review other functions that might be impacted by editing the data in the field (dependencies). This process can be configured to require up to two levels of approval.
6	Set up visit windows and approval settings	Configuration Manage Visit Schedule	The initial visit schedule is set during the design phase of the study. You can adjust the following: Visit windows. Out-of-window approvals. Out-of-window Hard Stop. Missed visit. Do Not Dispense (DND) days.
7	Edit data during subject transactions	Subjects All transactions	If subject edits are authorized for the study, a user can correct subject information collected during a visit. For more information, see Roadmap: Subject visits and The process of correcting subject information in the User Guide.
8	Approve or reject requests to edit subject information	Approvals Subject approval	If approval is required, IRT sends a notification to the user assigned to the roles that are configured to review the type of correction. For more information, see Roadmap: Approvals in the User Guide.