A participant cannot change an ePRO once it is completed. When an answer has to be corrected, for example after discussing it with the participant, a member of the site team can do it from the ePRO records. Every change is kept in the audit trail.
🔑 Prerequisite: the Edit permission on ePRO Records List in your study role.
Which change do you need?
You want to | Use |
Correct an answer | Edit on the record, then change the value |
Remove an answer entered by mistake | Edit on the record, then delete the field |
Record that an answer is not available | Missing/Unknown on the question |
Answer for a participant who cannot use a device | Edit on the record and fill in the value. |
⚠️ Warning
An answer changed by the site team is no longer strictly participant-reported. Make sure your study procedures allow it before you correct anything.
The completion date is updated each time a completed record is saved again. It then shows the date of the last correction, not the date the participant finished.
Corrections are no longer possible once the ePRO form or the ePRO form status is Ended.
Correct an answer
Open the record from the ePRO records list. The Edit action stays available on completed records.
🛠️ Step by step guide
Go to ePRO records in your study.
Find the record, using the filters if needed.
Click the three dots at the end of the row, then Edit.
Change the answer. It is saved as soon as you leave the field, and Saved appears next to the question.
Close the window.
If your study uses Reason for change. Answers that are already saved are locked. You unlock them one at a time, and each change asks for a reason. See Enable and use the "reason for change option".
🛠️ Step by step guide
In the Edit window, click the three dots next to the question, then Edit answer.
In Reason for changes, type the reason, then click Submit.
Change the answer, then click outside the field to save it.
Remove an answer
In the Edit window, click on the three dots next to the question and select "delete answer" If your study uses Reason for change, click Edit answer and give the reason first, as above.
If the question is required, the record goes back to Uncompleted until a new answer is entered. See Understand ePRO record statuses.
Record a missing or unknown answer
When the participant cannot give an answer, record why rather than leaving the question empty. Missing/Unknown is only offered on a question that has no answer yet, and only to the site team: participants do not see it.
🛠️ Step by step guide
In the Edit window, click the three dots next to the question, then Missing/Unknown.
Choose the reason: Not Done, Not Applicable, Unknown, Not Asked or Asked but unknown.
Add a comment if it helps, then click Submit.
The question then shows Missing/Unknown answer reason with the reason you chose. It counts as answered: when every required question is answered or marked Missing/Unknown, the record becomes Completed.
Find every change in the audit trail
Each change is logged in the study audit trail under the event type ePRO Records.
Change | What the audit trail shows |
New answer | Answered: the value entered |
Corrected answer | Answer Updated: the old value, the new value and the reason |
Removed answer | Answer Deleted: the old value and the reason |
Missing/Unknown | Answered: the value unknown, the reason chosen and the comment |
Every entry also shows who made the change, the date and time, the ePRO, the question and its variable. Open Audit Trails in the study menu, then click Details on the line. See Read and export the study audit trail.
💡 Tip: write a reason a monitor can follow, for example the source or the call with the participant. A reason that only says "correction" does not tell anyone what happened.