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.

0:000:00

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

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.

Medical Review Workbench

The Medical Review Workbench is the medical monitor’s workspace. At the top is a safety summary: how many records await review, how many are flagged, and how many open medical queries there are. The queue is organized into tabs:

• Inbox — records with status Not reviewed;
• Flagged — those marked for attention;
• Reviewed — those already processed.

The table shows the subject, visit, form, field, value, queries, flag comment, and update time. A filter by form helps you focus on the relevant domain (e.g., adverse events, concomitant therapy, laboratory results).

Review marks

1. Open the Inbox tab and consider the record in its clinical context.

2. Click Reviewed — the record moves to Reviewed.

3. If the record needs attention, choose Review… and set the Reviewed with flag mark with a mandatory comment.

A flag must be explainable

The “Reviewed with flag” mark cannot be set without a comment. A flag with no explanation is useless at safety reviews and during inspection, so a comment is mandatory.

A mark can be removed — returning the record to the Inbox (the “Clear mark” action, audited). The bulk action “Mark selected reviewed” marks several records at once; each mark is audited individually, resulting in “Marked N of M”.

Medical queries

If the physician has a clinical question about the data, they open a query of type “medical” on a field or record. Such a query follows the same lifecycle and lives in the same worklist as the rest, but is tagged with the Medical type — making it easy to filter. Routing is by permissions within scope, as for any query.

Re-review after edits

Medical review, like SDV, does not survive a data change.

An edit returns the record to the Inbox

If data changes after a “Reviewed” mark, the system synchronously returns the record to Not reviewed, and it reappears in the Inbox for re-review. This way “reviewed” always refers to the current value.

Blinded data is masked

If the medical monitor has no access to unblinded data, blinded values are masked — they see ••• and a lock icon, not the value. A review mark can be set on a masked field too, but the interface clearly shows that the value is hidden. The mask is end-to-end: it applies in the queue, in the audit, and in the export.

Medical review is not data cleaning

Medical review is orthogonal to data cleaning, SDV, and form status. It does not “close” queries or verify data — it is a separate physician’s view. That is why it has its own status axis and its own workspace.

QueriesThe query lifecycle, including the medical type.

Medical codingCoding terms lives in a module on top of the core.

Source Data VerificationVerifying data against the source — a monitor's parallel task.

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