Site Monitoring Visit Preparation Best Practices

Keep complete, up-to-date records throughout the study to save time preparing for monitor visits.

• Confirm that all consent forms are signed and dated by all the appropriate people at the time of consent. Document that the consent form was reviewed along with any questions that the participant asked during the consent process. The consent form is the most important document in the participant’s research chart.
• Always have most recent versions of the consent form and protocol.
• Maintain accurate and up-to-date specimen logs (storage, tracking, etc.), and study product accountability (receipt of study product, inventory, accountability log, temperature log, destruction of product log, etc.) if applicable.
• Make sure all Adverse Events (AEs) and Severe Adverse Events (SAEs) are reported timely and accurately during the course of the study.
• Make sure all protocol deviations are reported timely and accurately during the course of the study.

Core(s): Regulatory Knowledge and Support