Monitoring the quality of conduct of clinical trials: a survey of current practices.

Background: There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings.

Purpose: The purpose of this project was to describe current methods of monitoring clinical trials and to explore the rationale for the use of those methods.

Methods: An electronic survey of known monitoring practices was developed and sent to over 200 organizations involved in conducting clinical research.

Building quality in clinical trials with use of a quality systems approach.

There is an increasing focus on having quality systems in place during the planning stages of clinical trials. Such systems require the development and implementation of standards for each step. Although this is not imposing something totally new on clinical research, a systematic approach will produce a more reliable and useful end product--high-quality data obtained without compromising the protection of human subjects' rights and welfare.