CT06: Clinical Trial Monitoring: Site Evaluation and Setup

Description

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

The purpose of investigational site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified, trained and committed staff with adequate time and facilities, and that it is fully prepared for the safe and successful conduct of the clinical trial. In this module we set out the criteria, procedures and documentation for evaluating a site and setting up a trial there.