The Reason for Change option allows you to capture why a data entry was updated. This supports GCP compliance by ensuring all changes are visible in the audit trail, including who made them, when, and the previous value.
⚠️ Important: Once the study is Live, this option cannot be enabled or disabled. Make sure you configure it during the Draft phase.
Enable the reason for change option
🛠️ Step-by-step guide:
How to enable reason for change option
How to enable reason for change option
Go to your Study settings.
Click the Options tab.
Click Edit in the top-right corner.
Enable the GCP (Reason for Change) slider.
Click Save in the top-right corner.
See the reason for change in action
🛠️ Step-by-step guide
How to test the reason for change
How to test the reason for change
Open the Inclusion List.
Select a participant.
Find the answer you want to update and click the three dots (action button).
Click Edit answer.
In the modal pop-up, enter the Reason for the change.
Click Submit, then update the data.
Check the audit trail
🛠️ Step-by-step guide
How to check the audit trail
How to check the audit trail
From the study menu, go to Audit Trail.
Find the record you want to review and click Details.
💡Tip: Using the Reason for Change option supports GCP compliance by ensuring all data updates are fully traceable.