Assignment #$1($Maximum $-8-10$ pages of narrative $-$ double spaced. The report template will not be included in the $8-10$ page limit$)$

The Wonder Drug study is well underway and you, as a Lead CRA in the project, now have to visit your sites and perform interim monitoring activities.

Please provide an overview of the role and importance of monitoring in a clinical trial, its tactical importance as a Quality Assurance function and the impact that this function has on subject safety and data quality. Please discuss the role that Risk Based Monitoring will play in optimizing resources and maximizing quality within Clinical Monitoring and highlight the tactical components of this strategy within the quality control framework of a clinical trial. As part of your review and research, please present your assessment of whether Risk Based Monitoring has been impactful in improving the quality and efficiency of the monitoring of clinical trials.

To support the tactical side of monitoring, develop a simple site monitoring report that you will use to capture the specific activities executed during the visit. This report will also need to be set up to document all findings and observations identified during your visit. Special considerations will need to be given to the fact that this report is a key deliverable for the project manager and will be the critical conduit for their information about each site. Please realize that although you have already initiated the site into the trial, this will be your first monitoring visit and you will need to take a broad snap shot of how the site is achieving its goals and objectives for the trial.