Monitoring visits (interim monitoring visits, IMV) set the rhythm of a site once enrolment is under way. They have two inseparable priorities: patient safety and data reliability, in line with the protocol and Good Clinical Practice (ICH E6).
What I check at each visit
- Informed consent: presence, version, dating and consistency for every patient
- Adherence to eligibility criteria and the protocol
- Agreement between source data and the case report form (targeted verification or SDV per the plan)
- Reporting and follow-up of adverse events
- Investigational product handling: receipt, storage, accountability, returns
Risk-based monitoring
ICH E6 (R2) moved the cursor: rather than checking everything everywhere, the effort concentrates where the risk to patients and data is highest. Smart monitoring follows a risk-based plan, documents each deviation and — above all — closes corrective actions. Following actions through is what makes the difference, not simply showing up.
How I work
I prepare each visit from the data already captured, prioritise the sensitive points, and deliver an actionable report: findings, deviations, actions, deadlines. Between visits, I keep track of open actions so none is left unanswered.
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Reference: ICH E6 (Good Clinical Practice), risk-based monitoring.