[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives]

Abstract

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participating of human subjects. Since 1997 the ICH-GCP Guideline has been a requirement for conducting clinical trials which should be used as documentation to the authorities. The 13 fundamental principles of the ICH-GCP Guideline for conducting clinical trials are described. Furthermore, the most essential responsibilities of the investigator, sponsor and sponsor-investigator are mentioned. Investigator-initiated trials do not need to be conducted according to the GCP-principles but after the implementation of the EU Directive 2001/20/EC this will be changed. Today the GCP-principles only apply to clinical research with drugs but within a few years the GCP-principles will probably be a requirement for all clinical research.