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Monitoring is designed to verify the quality and safety of a study and ensure that it is conducted, recorded and reported according to the protocol (and any conditions of approval or subsequent amendments), written procedures, GCP and the applicable regulatory requirements.

The monitoring requirements for a study should be considered early on in the study development and incorporated in the protocol (as there may be cost implications). The protocol and risk assessment will be used to inform the overall approach for sponsoring and managing a specific study. Clinical trials are likely to have additional monitoring requirements and these will need to be documented in a study-specific monitoring plan.