Medizinische Sicherheit und globale Gesundheit

Medizinische Sicherheit und globale Gesundheit
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ISSN: 2574-0407

Good Clinical Practice

Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. GCP enforces strict guidelines on ethical aspects of a clinical study. High standards are required in terms of documentation for the clinical protocol, record keeping, and training. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. Ongoing research shows that whether conducting research involving a new drug, a behavioral intervention, or an interview or survey, GCP provides investigators and their study teams with the tools to protect human subjects and collect quality data.

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