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Table 2 Recommended on-site monitoring activities based on study risk classification. Informed Consent (IC)

From: Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

Risk of Study Initiation visit Interim visit Content of interim visits Close out visit
Low optional after first patients, then adaptable (e.g. 1/year) Endpoints (extent to be defined), IC (usually 100%) optional
Intermediate mandatory after first patients, then adaptable (e.g. 1/year) Endpoints (extent to be defined), IC (usually 100%), safety (usually 100%) mandatory
High mandatory after first patients, then in regular intervals Endpoints (extent to be defined), IC (usually 100%), safety (usually 100%) mandatory