Section 5.1 of the ICH GCP requires the sponsor of a clinical trial (or any party to whom the sponsor has delegated any trial related duties and functions) to implement and maintain systems for quality assurance and quality control. Similarly, Article 2 of the GCP Directive 2005/28/EC requires the implementation of procedures necessary to secure the quality of every aspect of the clinical trial. The aim of these quality requirements is to provide assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible. However, the growing cost and complexity of clinical trials threaten the ability to generate new and reliable data while maintaining high-quality trials.
This presentation will discuss how applying the Quality by Design (QbD) approach to a clinical trial can help identify important errors that could jeopardize the ability to protect patients during the trial and to obtain reliable results and meaningful information from the trial.