Add a reason when you change a value (GCP) in CDMS
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Table of Contents
Adherence to Good Clinical Practice (GCP) requires you to provide a rationale for making changes to entered data after an initial value has been set.
Enable GCP features
To enable this feature, under Study Settings, in the GCP section, select Yes:
Enabling GCP option ‘Confirm changes’ means that any time a user attempts to change previously entered data in a record, they will be required to add a reason for the change in order to save the new value. The user has 30 seconds after the entering of the data to amend or change the value without being required to provide a reason, after this any further amendments must be justified in the dialog window. The reason for change will not be prompted if the data is being entered for the first time and the 30 second time allowance has not expired.
Add a reason for change
For example, in a field you have realized that you have checked the wrong box in a checkbox field and you want to change this. If you attempt to select a new box, you will be prompted to add a reason as seen in the screenshot below.