When assessing the monitoring needs for a study, sponsors should:

Sponsors must ensure that monitors are adequately qualified, possessing the necessary scientific and clinical knowledge to effectively oversee the trial. This ensures that monitors can accurately assess protocol compliance, data integrity, and participant safety. The quality of monitoring directly impacts the credibility of the trial outcomes.

GCP guidelines specify that monitors must be adequately trained and knowledgeable about the trial protocol, investigational product (IP), and clinical research standards.

"The sponsor must ensure that monitors have appropriate qualifications and training to conduct effective trial monitoring."

Objectives:

Maintain data integrity through skilled monitoring.

Ensure patient safety and protocol compliance.