CTTI is pleased to make available the plan for the following project: Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials. This project will result in a white paper that describes current monitoring methods, establishes the key quality assurance objectives within clinical trials, and considers the strengths and weaknesses of current monitoring methods in meeting these objectives, highlighting best practices for a range of clinical trial settings.  The paper should provide medical product researchers with information to assist them in selecting the most appropriate monitoring methods for each particular trial, thereby improving quality.