Monitoring and safety: every finding followed to the end

Your visit

• A monitor's week is site visits, reports, and findings that have to be followed to the end.
• In MAESTRO, Site Monitoring starts with a scheduled visit: the site, the type, the dates, and the monitor.
• The monitor is notified, in the app and by email, and finds the visit under My Visits.

Report

• After the visit, create the report: six sections, saved as a draft.
• Each finding gets a severity and a category. Add an owner and a due date to follow it up.
• Submit it for review. The reviewer approves it, or requests revisions, with mandatory notes.
• Every hand-off sends a notification, and the report exports as a branded PDF.

Safety

• For safety, report an adverse event with its onset date, severity and relatedness, and flag it when it is serious.
• MAESTRO checks the dates as you save: no onset in the future, no resolution before onset.
• Switch on timeliness tracking, and serious-event reporting is measured from the date you first became aware, as a risk indicator.

Deviations

• A visit completed nine days late files its own deviation, with the reason written by the system.
• Major and critical deviations send an alert as soon as they are filed.
• A reviewer approves, rejects, or escalates. And if the visit date is corrected, the deviation is withdrawn, not deleted.

Quality

• When a deviation needs a quality decision, confirm it as a quality event: a draft in Quality Management, linked both ways.
• A monitoring finding can be raised the same way. Nothing becomes a CAPA on its own.

Monitoring and safety in MAESTRO: every finding, and every event, followed to the end.