Corrections, Queries and the Audit Trail

Part of Decentralized Trials (DCT) Training: ePRO and Participant-Entered Data.

About 2 minutes. Free, in your language, no account needed.

Participant-entered data is source data

That is the part people forget. The participant's entry is the original record, and it is subject to the same expectations as any source document.

It is attributable, it is timestamped, and changes to it are tracked.

You generally cannot change it

A coordinator should not be editing a participant's reported outcome. If a value is wrong, the route is a query to the participant, or a documented note explaining the issue.

Editing it makes the coordinator the author of a patient-reported outcome, which is a contradiction.

Raise a query with the actual question

"Please confirm the entry for 3 March" is weak. "On 3 March a pain score of 9 was entered and the following day the diary records no pain and no medication taken. Can you tell me what happened on the 3rd?" gets an answer.

Do not lead toward the convenient answer

A query phrased as "was that entry a mistake?" invites a yes. That changes the dataset in the direction of tidiness rather than truth.

Ask what happened, not whether it was an error.

Impossible values usually have a boring explanation

A weight of 7 kilograms, a temperature of 3 degrees, a date in the future. Fat fingers, wrong units, the wrong field.

They are worth checking and they are rarely sinister. Check them promptly, because a participant remembers last Tuesday and not last quarter.

Know what the audit trail records

Original value, changed value, who changed it, when and why. If the system does not capture a reason, the reason must live somewhere that is part of the record.

A change with no reason is the single most inspected item in electronic data.

Reconcile ePRO against the rest

Diary entries, device data, visit records and adverse event reports should tell a coherent story. Where they do not, that is either an error or a finding.

Nobody downstream is positioned to notice. You are.