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 |