The Action Item Report is a daily report users can check for any items that need to be addressed. This report is accessible on both a browser and the mobile app so users are able to maintain the most current study data.
Scroll further down this page for directions on the website Action Item Report.
1. Open the Study tab from the navigation menu.
2. Select the Action Item Report from the menu.
3. Select the applicable study site (for users that belong to more than one site).
4. Open the appropriate action item list (these items are described in more detail below).
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 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 review on the record.