The sponsor should develop a monitoring plan that is tailored to the identified potential safety risks, the risks to data quality and/or other risks to the reliability of the trial results. Particular attention should be given to procedures relevant to participant safety and to trial endpoints. The plan should describe the monitoring strategy, the monitoring activities of all the parties involved, the various monitoring methods and tools to be used, and the rationale for their use. The monitoring strategy should ensure appropriate oversight of trial conduct and consider site capabilities and the potential burden. The plan should focus on aspects that are critical to quality. The monitoring plan should reference the sponsor’s applicable policies and procedures.
Monitoring of important data and processes (e.g., those related to primary endpoints and key secondary endpoints and processes intended to ensure participant safety) performed outside the investigator site (e.g., central image reading facilities, central laboratories) should be addressed in the monitoring plan.