Good Clinical Practice (GCP; German translation: Gute Klinische Praxis) is a set of international standards and principles designed to regulate the ethics, quality and reliability of clinical trials on humans. GCP defines the standards that researchers, sponsors (translation into German: Sponsoren; organizations or companies that fund trials) and regulatory authorities (German translation: Zulassungsbehörden) must adhere to in order to ensure that the rights and safety of trial participants (German: Studienteilnehmer) are protected and that research results are reliable.

The basic principles and requirements of Good Clinical Practice include the following:

• Ethics: Every clinical trial must be conducted in an ethical manner so that the rights and welfare of the subjects are respected. This includes obtaining informed consent from each subject and incorporating ethical considerations into all aspects of a study.
• Study protocol and planning: For each clinical trial, a detailed study protocol (German translation: Studienprotokoll) describing the methods and objectives of the study must be drawn up. The study design should be clearly defined and changes to the study must be documented and approved by the competent authorities.
• Staff qualification: All members of the research team must be qualified and trained in accordance with GCP requirements.
• Compliance with the data: The data obtained as part of the study must be valid, reliable and complete. Data must be documented and stored in a safe place.
• Monitoring and testing: Studies are monitored and tested to ensure compliance with GCP principles and the study protocol.
• Informed consent: All subjects must be adequately informed about their participation in the study and give their written informed consent.
• Medical records: Medical documentation must be clearly marked and access to the medical records of the study participants must be restricted to authorized persons.
• Compliance with laws and regulations: All clinical trials must comply with national and international laws and regulations, including registration and reporting.

Compliance with Good Clinical Practice is essential in order to ensure the reliability of data obtained in clinical trials and to protect the rights and safety of trial subjects. These standards help to facilitate the development of effective new drugs and medical technologies and to promote public trust in medical science and the pharmaceutical industry.

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