What this is, and who it is for
A value that has been saved is part of the record: it is not overwritten. To change it, someone has to ask (raise a query on the value) and the site then corrects it with a reason. The earlier value, the new value, the reason, the person and the time are all kept. This page is how a correction is made; the query side is on Work with queries.
| You need | To |
|---|---|
clinical.query.raise (project manager, data manager, medical officer, clinical research associate, site monitor) | Raise the query that opens a value for correction |
form.write (site coordinator, principal investigator) | Make the correction |
signature.sign (principal investigator) | Sign the record again if the change withdrew a signature |
Held by: Project Manager, Clinical Research Associate, Data Manager, Medical Officer, Site Monitor (clinical.query.raise).
Where to find it
On the participant's form screen, a saved value shown read-only with a notice: Values already saved are read-only. A value opens for correction when someone else raises a query on it, and saving the correction needs a reason. For a signed and locked record the notice says This record is signed and locked, so its saved values are read-only. … A correction withdraws the signature.
What you can do
- The reviewer raises a query on the value (a flag on the field, or the Queries screen). The edit checks also raise queries by themselves (Validation, edit checks and their severities).
- The field opens for the site coordinator, who sees the query on the field. A query you raised yourself never opens the value for you.
- The coordinator changes the value and chooses Submit form. A dialog asks the Reason for change (Transcription error corrected against source; value re-measured at the visit), listing what is changing, from the old value to the new, and says The reason is recorded in the audit trail with the earlier value (21 CFR Part 11 §11.10(e)).
- The value is saved. The query is not answered by the save: the toast says the query on the corrected value is still open; answer it from the flag on the field, or the Queries screen (Work with queries). When the check that raised an automatic query no longer fails and nobody has answered it, it closes by itself.
Correcting a signed record
If the record has been signed, the dialog says {name}'s signature (Investigator responsibility, {time}) will be withdrawn and the record will need signing again. Both stay in the audit trail. After you confirm, the signature is shown as withdrawn (superseded) and the principal investigator signs again (Sign records).
Someone else saved first
If another person saved the same record while you were editing, the dialog This record changed while you were editing shows what changed and lets you keep yours or the current value for each (Enter visit data).
Completed, withdrawn and lost participants
A participant who no longer takes data still allows a correction through a live query, and only of the values the query is about: Data capture is not allowed for a Completed subject. A saved value of the record can be corrected only by answering a query on it. No record is created for them.
- Saves the correction with its reason.
Every option
What a reason is
A reason is required whenever a previously entered value is changed, and, once a form has been marked complete, whenever anything is added or changed. It is free text and is stored on every changed value.
What counts as a query that opens a value
A query that is still live (open, answered, reopened or escalated), is about that value (one on a table cell opens that cell, one on the field opens every cell of it) and was not raised by the person editing. A query raised by the edit-check engine has no raiser and opens the value for anyone who may enter data.
What the system records
form.field_modified with the earlier value, the new value, the reason, the person and the time; record.unsigned if a signature was withdrawn (and the signature's own signature.superseded); the query events. Nothing is overwritten. See Audit events.
What you cannot do, and why
- Change a saved value on your own initiative. A correction needs a query from someone else, so no one can flag their own entry, change it and close the query.
- Correct without a reason. The dialog will not continue.
- Delete a value. A cleared value is a change with a reason; the earlier value stays.
- Change a locked study's data. Unlock the database first (Close and lock a study).
- Correct as a study-team role. The Data Manager asks; the site corrects.
Compliance Q&A
Yes. A saved value can change only where a query from someone else authorizes it, a reason is required, and the earlier value, the new value, the reason, the person and the time are kept in the audit trail in the same transaction as the change. A change to a signed record withdraws the signature visibly.
Evidence: server data-capture save-responses.ts (reason for changefield-level audit with before and after in the same transactionquery authorization hasActiveFieldQuery)client correction-gate.ts
Related
Enter visit data · Work with queries · Sign records · Review the audit trail · Data Manager