CRPV206 Clinical Trials Monitoring

Clinical trial monitoring is an important aspect of the clinical trial process, as it helps to ensure the quality, safety, and ethical conduct of the trial. Clinical trial monitoring refers to the ongoing supervision and review of the clinical trial activities, from the initiation of the trial to its completion. Clinical trial monitoring helps to ensure that the trial is conducted according to the study protocol and relevant regulations, such as the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and the regulations of the local ethics committee. This course introduces students to the risk-based approach in the monitoring process. In this course, students will learn how to create a monitoring plan, select qualified investigators, research site training and activation, execute the monitoring plan, and site closure upon conclusion of the study.

Learning Points:

• Roles and Responsibilities
• Pre-Study Functions – Selecting Investigators/Site Assessment
• Sites set-up – Investigators Meeting/Site Training/SIV
• During Study – Recruitment Strategies/Patient Compliance/Risk-Based Monitoring
• Effective Site Monitoring Tools and Visit reports/Risk Based Monitoring
• Common Audit Deficiencies
• Monitoring Report writing