The Reason for Change option makes anyone editing an existing answer say why. It supports GCP compliance, because every change then carries who made it, when, the previous value, and the stated reason, all readable in the audit trail.
⚠️ Warning: once the study is Live, this option can no longer be enabled or disabled. It has to be decided during the Draft phase. A study that goes Live without it cannot have it added, and a study that goes Live with it cannot have it removed.
Enable the option
🛠️ Step by step guide
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.
What your sites will see
Once it is on, editing an existing answer opens a modal asking for the reason before the change is accepted.
🛠️ Step by step guide
Open the Inclusion List.
Select a participant.
Find the answer to update and click the three dots.
Click Edit answer.
Enter the reason for the change in the pop-up.
Click Submit, then update the data.
Check it in the audit trail
🛠️ Step by step guide
From the study menu, go to Audit Trail.
Find the record you want and click Details.
💡 Tip: tell your sites what a good reason looks like before the study opens. The option guarantees a reason exists, not that it is useful, and a database full of reasons reading "correction" will not satisfy a monitor asking what actually happened.