The Clinical Trials Transformation Initiative (CTTI) has been conducting a project to identify effective and efficient methods to monitor clinical trials. In seeking to identify how best to ensure the reliability of study results and the protection of trial participants, the project team has recognized that quality cannot be “inspected into” a trial but rather must be incorporated from the outset in the trial’s protocol design and operational conduct. To be effective, monitoring should be one component of an overall quality framework that allows potential issues to be identified and addressed as early as possible.
Describe, discuss, and evaluate novel approaches to clinical trial oversight
Propose an integrated model of quality management that will promote more efficient approaches to design, conduct and oversight of clinical trial
Identify the critical aspects of clinical trials that should be the focus of risk-based approaches to creating quality systems
*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.