The Action Item Report is a daily report users can check for records that are missing (past due), or records needing review, depending on the user's role. This report is accessible on both the website and the TrialKit mobile app for flexible access.
Items within the report that users can see will depend on the permissions granted to them by the Study Manager.
Reference the image below for the following annotated descriptions:
1. Select the applicable study site (for users that belong to more than one site).
2. Data changes with no reason provided: List of all records containing data changes where a reason for the change was not provided after the form was re-saved. Reasons must be provided before the record can be opened and viewed by other users. This is used for the data audit trail per Part 11 compliance regulation.
3. Missing CRFs: List of scheduled visit forms which are past their visit window.
4. Review/Workflow Levels: Depending on the study workflow, this section will list the records ready for review. In the example above, any user can open records from the list, but only a Monitor will be able to actually perform a review on the record.
1. Open the Reports list from the main bottom navigation menu
2. Select the Action Item Report from the list:
3. Select the applicable study site (for users that belong to more than one site).
4. Open the appropriate action item list (these same items were described in more detail above).