Answer a query

A query is a question about the data: a discrepancy with the source, a clarification, a remark. It is opened by the monitor, the data manager, the medical monitor or the system itself (a check fired). Your task as coordinator is to answer: explain the value or correct it, so the query can be closed.

Who and when

Coordinator — the site coordinator. You need the permission to answer queries (query.answer) at the site; to also fix the value — the permission to edit a saved value (data.update). The task comes up when a query appears in Tasks, a form shows an open-query counter, or a notification says your answer was rejected.

Before you start

• The query is Open. An answered query cannot be answered again — it waits for the monitor’s decision.
• The area is not under a hard lock.
• The source document to check the value against is at hand.

Steps

1. Open Tasks → the Queries tab. Rows are grouped by study; each shows “Answer the query «field»”, the subject, the start of the query text and its age (overdue ones say “overdue”). Queries assigned to you are lifted to the top with an “assigned to me” tag.

2. Click a row — the query thread expands below it: the question and all replies. If you need the form’s context, click Open form — the form opens focused on the field.

3. Check the value against the source document.

4. If the value is correct, write an explanation in the “Your answer…” box and click Send answer.

5. If the value is wrong, fix it (see below), then answer in the thread what was corrected. An automatic query closes by itself once fixed — no answer is needed.

Answer on the form

Queries are also visible right on the form — in the Queries panel. Each query has the same thread with an answer box and a Send answer button; the Go to field → link takes you to the field in question. Closed and cancelled queries are folded into “Resolved (N)”.

Fix the value from the query

On the subject casebook’s Queries tab (and in the study’s query queue) the thread comes with a field card: “Current value” and a Fix value button (for an empty field — Fill in).

1. Click Fix value, enter the new value and click Save.

2. Choose a reason in the “Reason for Change” dialog — for example, “Correction per monitor’s query” — and confirm. More on reasons in Correct a saved value.

3. Read the outcome under the card: “Value saved. The query stays open — answer in the thread or close it” — then answer in the thread; or “Value saved — the check passed and the query closed automatically” — then nothing else is needed.

An edit made from the thread is linked to the query in the audit trail — not only through the reason text. A blinded, auto-filled or condition-hidden field cannot be edited from the card — the card points you to the form.

What happens

• The answer moves the query Open → Answered; you see “Answer saved — the query awaits closure by the monitor or data manager”. The answer does not close the query.
• The answer is added to the thread and to the audit trail with author and time.
• Whoever opened the query is notified “Query … received an answer”, and the monitor’s Tasks show “Review the query answer”.
• Then the monitor (or data manager) decides:
  • Close (accepted) — the query moves to Closed, and you are notified of the closure;
  • Reject answer… — with a mandatory reason; the query returns to the site as Open in a new round, and you receive “Query … was reopened — the answer needs more work”.
• Fixing the value follows the normal edit path: reason for change, SDV and medical review reset, invalidation of a covering signature.

1. Openyou answer
2. Answered
   • monitor rejects the answerOpen · new round
   monitor accepts
3. Closed

A query through the coordinator's eyes: an answer hands it to the monitor, a rejection returns it to the site in a new round.

If it doesn’t work

• No answer box and no “Send answer” button — you lack query.answer in the query’s area, or the query is already Answered, Closed or Cancelled.
• “Only an open query can be answered” — the query changed status while you were typing (for example, it was closed). Refresh the page.
• No “Fix value” button — the card explains why: “You have no permission to change this value”, the form is locked, or the field is blinded, derived by a rule or hidden by a condition. The last three are edited on the form.
• “Someone else just changed this value — the context was refreshed, review and retry.” — a value version conflict. Check the current value and repeat the edit.
• Refused because of a lock — a hard lock covers the area: you can neither answer nor fix the value.
• The edit opened new queries (“The edit opened N new queries”) — the new value violates another check. Work through those too.
• The query is not in Tasks — the queue is built from permissions: it holds exactly the queries you may answer. Check the subject casebook’s Queries tab.

Next

Correct a saved valueThe reason for change and what an edit resets.

Manage queriesQuery types, closing, reopening, queues — from the monitor's side.

Your task queueHow Tasks works and why an assignment is a tag, not a permission.

More detail

How to answer

• Do not quote blinded values. The answer text is not masked — describe the problem without revealing the value.
• Do not enter the participant’s personal data in the answer.
• One thread per problem. All replies — question, answers, resolutions — live in one thread; it counts rounds (how many times the query went back for rework). If your answer was rejected, continue in the same thread.
• Response time. A query may have a due date (SLA); overdue ones are highlighted. The system never closes queries on a timeout — an overdue query waits for an answer.

Automatic queries

An automatic query (type “Auto”) is opened by the rule engine when a check with the query action fires on save. It closes by itself once the data is fixed and the check no longer fires. If the value is correct and the check fires legitimately (for example, a clinically confirmed deviation), answer with text — the monitor or data manager will decide.