Setting the scene and ICH GCP in clinical and healthcare research

Abstract

This chapter looks at the purpose and history of the development of good clinical practice (GCP). The international conference on harmonisation (ICH) GCP is the international quality standard for conducting clinical research to ensure the rights and well-being of patients are protected and the resulting data are valid. The cornerstone of ethics in research stems from the Declaration of Helsinki and the chapter looks at the changes in the Declaration and the impact on clinical trials. The development of the ICH process is described and the E, S, Q and M guidelines are discussed, The efficacy guidelines affect the practical aspects of trials and the efficacy guideline number 6 (E6) is on GCP. The content of the E6 guidelines is reviewed including the responsibilities of ethics committees, investigator and sponsor. Documentation requirements including the Protocol and Investigator Brochure as well as all the other documents are outlined. The guidelines are written to be interpreted and companies and institutions have to document their interpretation using standard operating procedures (SOPs). Although ICH GCP is regarded as the world-wide standard it sits alongside countries' legislation. In Europe CTIMPs have to follow the EU Directives and Regulation. Non pharmaceutical/non interventional healthcare research has no legal requirements to adhere to ICH GCP and is carried out under different research governance frameworks (RGF), however they all have their principles based on ICH GCP. The chapter also discusses the definition of an IMP and the decisions and processes that have to be followed when conducting non CTIMP studies.