Summary
This article is an overview of the Reason for Data Change alert.
Table of Contents
When audit changes to Subject CRF Data is enabled at the Study Configuration, the system will force a reason for data change to be provided for each field changed within the Subject CRF. Configuration options related to what reasons can be provided are also made under the Audit menu at Study Configuration.
When a Reason for Data Change is assigned successfully, detail can be viewed at the Subject Record Change Audit report or in the Form Audit Table.
On the Web
When data is changed in the Subject CRF and the user selects the Save button, the system saves the data and a Save Form Messages popup window (as shown in the figure below) is displayed indicating a reason for the change must be provided.
If the user navigates away from the Provide Reason for Changing Subject Data page before providing a reason, a reminder icon will be placed in the corresponding section of the Subject Visits and Events Manager page as shown in the following figure.
In addition, the Action Item Report for the data entry person will display the Data Changes Awaiting Reasons data table as shown in the figure below.
The data table indicates subject CRF data was changed and no reason was provided for the change. The form will not be accessible for a reviewer until all reasons have been given and the form appears in a green check status. Clicking on the icon or link to open the form entry screen for the form will automatically take the user back to the provider Reason for Changing Subject Data form where a reason can be provided.
On the App
When data is changed in the Subject CRF and the user selects the Save button, the system saves the data and a red flag is displayed at the form and field level indicating a reason for the change must be provided.
Clicking on red flag icon at the form level will open the Reason for Change dialog for all pending items related to the selected form. Reason for Change can be assigned to all field within a form using this option.
Clicking on red flag icon at the field level will open the Reason for Change dialog for the field. Reason for Change can be assigned to the field within a form using this option, or all pending fields within the form using the Use This Reason for the Entire Form option.
If the user navigates away from the form entry screen before providing a reason, a reminder icon will be placed in the corresponding Subject Manager, as well as the Subject Visits and Events Manager page as shown in the following figures.
In addition, the Action Item Report for the data entry person will display the Data Changes Awaiting Reasons data table as shown in the figure below.
The data table indicates subject CRF data was changed and no reason was provided for the change. The form will not be accessible for a reviewer until all reasons have been given and the form appears in a green check status.
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