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.