CTTI Meetings

Developing Effective Quality Systems in Clinical Trials: An Enlightened Approach

CTTI Project: Quality by Design

Meeting Location

Bethesda Marriott Suites, Bethesda, MD


CLICK HERE for a list of meeting attendees.
CLICK HERE for the meeting agenda.
CLICK HERE for the Executive Summary.


Meeting Background

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.


Meeting Objectives

  • 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


Meeting Presentations*

Defining the Underlying Principles of Quality in Clinical Trials

Approaches to Risk-Based Quality Management 


*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.