Medical review

The medical monitor's listings of adverse events, lab results and therapy on live data: marking lines reviewed, what "changed since the review" means, the medical query to the site.

The sponsor's medical monitor reads the safety data of every patient while the study runs: adverse events, lab results outside the normal range and the therapy. ICH E6(R3) asks the sponsor to review the safety data on an ongoing basis. Medical review gives the medical monitor three listings on live data, a mark for what was read and a medical query to the site, so the review is complete and documented and nothing changed afterwards slips through.

Who sees it

Open Medical review in the study menu. The medical monitor role is made for it: they see the listings and the forms of the patients, mark lines reviewed, raise medical queries and close them, and enter no data. The project administrator can do the same; the data managers read the listings without marking. Each person sees the patients of their own sites only, and a blinded member never sees the forms for the unblinded team. Invite a medical monitor on the Team page.

The three listings

• Adverse events: each saved adverse event form (a form with the AETERM field): the event, the period from start to end or “ongoing”, severity or grade, relationship to the study drug, outcome. A serious event carries a red mark; Serious only leaves just them.
• Lab results: each value outside the normal range set in the eCRF builder for a field of a lab form (HEM, CHEM, a code starting with LB and others), and each row of a lab table outside its range, with L (low) or H (high), the range and the date.
• Therapy: each concomitant medication (a form with the CMTRT field): the medicine, indication, dose, route and period.

The number on each tab is what is left to review there. Lines changed since the review come first, then the serious ones.

Mark lines reviewed

1. Tick the lines you have read, or the box in the head of the listing for every line on the page.
2. Write a comment if you wish, for example “consistent with the medical history”, and press Mark the chosen lines reviewed.

The mark keeps the line as it was read. If the site changes the event, the medicine or the value afterwards, the line shows Changed since the review and is counted in the tile of the same name until it is reviewed again.

Medical query

Press Medical query on a line, edit the text and press Raise the query. The query goes to the site on the term of the event, the medicine or the lab value, like any query, with the source “Medical review”. The line shows Medical query open with its number until the query is closed.

Filters and Excel

Filter by patient, site and state (waiting for review, medical query open, reviewed, all). Excel downloads the three listings as filtered, with the state, who reviewed and when, for the safety review meeting or the trial master file. Every mark, query and download is a record in the audit trail of the study.