Good clinical practice

Good clinical practice refers to an international ethical and scientific standard for planning, conducting, documenting, evaluating and reporting clinical studies (trials) in humans.

The protection of the study participants (informed consent = IC) and the quality of the study results are the focus of attention here. I.A. a sponsor (usually a pharmaceutical company) provides the investigational medicinal products, finances the study, commissions investigators and provides insurance cover (proband insurance). The sponsor has the main responsibility for the quality of the study data. The sponsor's tasks in conducting the clinical trial can also be performed by a clinical research organisation (CRO). The investigator and the trial site (usually a hospital) must meet numerous qualification requirements (sufficient qualification of study personnel, investigator must be familiar with the test substance, definition of responsibilities at the trial site, availability of sufficient resources). The Ethics Committee monitors the qualifications of the investigators and the protocol. A core component of GCP is quality management. Ongoing quality controls are performed by monitors who supervise a study on behalf of the sponsor. The sponsor is obliged to carry out randomly selected so-called audits in which the quality of the study performance and study data is checked. Furthermore, investigators, trial centres and sponsors are monitored by inspections of national drug authorities.