Perform a medical review

Medical review is the review of safety and efficacy data by the sponsor’s physician (the medical monitor). It runs in parallel with data cleaning and SDV without mixing with them: medical review has its own independent status axis. The goal is to notice what is clinically significant and, if needed, ask a medical question — not to “clean” data.

Who and when

Medical monitor — the medical monitor. You need the permission to perform medical data review (data.review.medical) on the study or site; to raise a medical query — query.open. The task comes up as safety data arrives (adverse events, concomitant medications, lab values) and every time an edit sends a reviewed value back for re-review.

Before you start

• The data is entered and saved: values with the Not reviewed status enter the review.
• The area is not under a hard lock.
• For blinded fields: only someone who sees the unblinded value (data.unblinded.read) can set a review mark — see More detail.

Steps

1. Open Medical review in the study menu, the Inbox tab. Narrow the queue with the form filter (for example, adverse events) or the “Subject, item, value…” search.

2. Pick a record on the left — the right side shows one value in clinical context: subject, visit, form, field, the number of live queries and a mini-diff of the last edit (if the record came back for re-review). History (key H) shows the value “before/after”.

3. If everything is fine, click Reviewed (key R) — the record moves to Reviewed, and the next one opens.

4. If the record needs attention, click Flag… (key F), write a comment and confirm — the record gets the Reviewed with flag mark.

5. If you need an answer from the site, click Medical… and raise a medical query on the value.

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The medical monitor's workspace: review queue, masked blinded values, and reviewing with a flag

Mark several records at once

Tick the records and click Mark reviewed (N). Each mark is set and audited separately; the result reads “Marked N of M”.

Reset a mark

On the Reviewed tab pick a record and click Reset mark… — the record returns to the Inbox. A reason is mandatory and the reset is audited. Clearing a flag (moving Reviewed with flag to Reviewed) is possible only with a resolution — a comment on how the question was settled: a safety flag is never cleared silently.

What happens

• The value’s review axis changes: Not reviewed → Reviewed or Reviewed with flag. The other axes (entry, SDV, signature) are not affected.
• Each mark is written to the audit trail with author and time (UTC); so are the flag comment and the reset reason.
• The record leaves the Inbox for the Flagged or Reviewed tab.
• A medical query appears in the common query queue with the Medical type and reaches the site through normal routing.
• If the coordinator later changes the value, the mark resets automatically and the record returns to the Inbox for re-review.

If it doesn’t work

• No “Medical review” menu item — you lack data.review.medical.
• No mark buttons, and under the value: “The value is blinded by protocol — reviewing the mask would be a false record” — the field is blinded and you lack the permission to see the unblinded value. The mark is set by someone who holds it.
• The flag is not saved: “A comment is required for “reviewed with flag”.” — add a comment.
• Resetting a mark or a flag fails — a reason is needed (for a flag — a resolution).
• A review operation is refused because of a lock — a hard lock covers the area.
• No “Medical…” button — you lack query.open in the record’s area.
• “Review queue is empty ✓” — everything is reviewed; new records appear as data is entered.

Next

Manage queriesThe query lifecycle, including the “medical” type.

Code termsMap adverse events and medications to dictionary codes.

Verify source data (SDV)Checking data against the source — the monitor's parallel task.

Status lifecyclesThe medical review axis and its reaction to data changes.

More detail

The medical review status axis

Mark	Meaning
Not reviewed	The record awaits medical review
Reviewed	The physician has reviewed the record
Reviewed with flag	Reviewed, marked for attention (with a comment)

1. Not reviewed
   • review with flagReviewed with flag
   review
2. Reviewed
   • value editNot reviewed

A value's medical-review axis. Editing data after review returns the record to “Not reviewed” for re-review.

The Medical review queue

The Medical review screen is the medical monitor’s workspace. Record counters sit on the tabs themselves, and below the title — the number of open medical queries, if any:

• Inbox — records with the Not reviewed status, including those back for re-review after an edit;
• Flagged — records marked for attention, with the flag comment;
• Reviewed — already processed records (marks are reset here).

Records are grouped by subject, visit and form; the form filter helps focus on the domain you need. The Tasks → Review rows lead to the same queue.

A flag must be explainable

The “Reviewed with flag” mark cannot be set without a comment. A flag without an explanation is useless in safety reviews and inspections, so the comment is mandatory.

Medical queries

If the physician has a clinical question about the data, they open a query of the “medical” type on a field or record. Such a query follows the same lifecycle and lives in the same queue as the others, but carries the Medical type — easy to filter on. Routing follows permissions within the area, as for any query. Only a holder of the medical review permission can close a medical query (accept or reject the answer).

Re-review after edits

Medical review, like SDV, does not survive data changes. If the data changes after the “Reviewed” mark, the system synchronously returns the record to Not reviewed, and it reappears in the Inbox for re-review — with a mini-diff of what changed. This way “reviewed” always refers to the current value.

Blinded data is masked

If the medical monitor has no access to unblinded data (data.unblinded.read), blinded values are masked — they see a lock and a mask, not the value. The mask is end-to-end: it applies in the queue, in the audit trail and in exports. A review mark cannot be set on a masked field: “reviewed” over a mask would be a false record. Such fields are reviewed by someone who has been granted unblinding explicitly.