1) Select the Audit tab in the Study Configuration Settings.
2) The Use Coded Instead of Free Text field for Reason checkbox should be selected to enable a dropdown list of prepared reasons to be used when subject data is changed. The figure below shows a coded field being used to capture field change reasons. The coded field requires that a reason be chosen from the dropdown list of choices.
3) This section below explains how to Add, Update, or Remove reason choices from the dropdown list.
The Use Coded Instead of Free Text field for Reason checkbox should NOT be selected if a specific reason as to why a field was changed must be provided by the user. The free text field enables the user to enter a more detailed explanation as to why the field was changed. The figure below shows a free text field being used to capture field change reasons.
Allow First Reason to be Inserted to All Other Reasons
The Allow First Reason to be Inserted to All Other Reasons checkbox should be selected if the reason for changing each field in the Subject CRF is the same. If checked, this option is selected, the Use Reason For All link will appear below the entry box (either coded or free text field) enabling the user to have the first reason (selected from the dropdown list or entered in the free text field) be used for all other field change reasons. When the link is selected, the first reason entered will automatically be copied and populate in the rest of the reason fields. After the link is selected, either the dropdown list or free text field(s) can still be utilized to change individual line items. To save the reasons provided, click the Save Reason For Changes button.