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Risk-Based Monitoring: A Checklist

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In practice, on-site monitoring visits should be considered early on in a study. Having a monitoring visit after the first patients have been enrolled allows the sponsor to determine whether the site fully understands the protocol and other study requirements. If issues are identified during an early visit, the sponsor can focus efforts on the sites that need them to obviate future risks to subject safety or data integrity. It is important to consider your level of risk when determining your monitoring approach. 

Risk-Based Monitoring

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