Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials with medicinal products for use in humans (GCP Ordinance)

The Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials with medicinal products for use in humans is also known by its short title GCP Ordinance (GCP-V). In Germany, it regulates compliance with Good Clinical Practice in the areas of planning, authorisation, implementation and documentation of clinical trials involving the use of medicinal products in humans. The aim is to protect and safeguard the rights, safety and well-being of the patients and test persons involved and to ensure the integrity of clinical trials.

Verordnung über die Anwendung der Guten Klinischen Praxis bei der Durchführung von klinischen Prüfungen mit Arzneimitteln zur Anwendung am Menschen (GCP-Verordnung, GCP-V) Online Version (German)

Ordinance on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for use in humans (GCP Ordinance, GCP-V) Online Version (inofficial English translation)

Wird geladen