The Require reason for any change to Subject CRF Data box must be selected to force the data entry person to provide a reason for each field they change in a Subject CRF. In this case, if the Subject CRF data is changed and the Save button is selected, the system saves the data a Save Form Messages popup window (as shown in the figure below) is displayed indicating a reason for the change must be provided.
When the Close Window and Provide Reasons For Changing Data button is clicked, the Provide Reason for Changing Subject Data form is displayed as shown in the figure below. Using the dropdown list of choices (or free text field) the user can provide a reason for the change.
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 CRFs Containing Data Changes and no Reason Provided 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 in the Form Status column of the data table will automatically take the user back to theProvide Reason for Changing Subject Data form where a reason can be provided. The status used for form that require a reason for change is the icon.