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GCP is defined as an international standard for the design, conduct, performance, monitoring, monitoring, recording, analysis and reporting of clinical trials or studies. GCP compliance provides public assurance that the rights, safety, and well-being of human subjects involved in research are protected.
GCP is an international quality standard provided by the International Conference on Harmonization (ICH). ICH-GCP coordinates technical procedures and standards; improves quality; Speeds time to market and lowers costs to sponsors and the public.
Infamous cases such as Nazi doctors conducting large-scale trials on unwilling prisoners during World War II, the Syphilis Study of black American men (1932-1972) who were not provided with research data. This was followed by the declaration of the Helsinki Accords between countries that there needs to be a global standard by which all judgments are governed.
This is good clinical practice – protecting those who are in the trial, but those who are treating will also rely on the data. This essentially ensures that the patient’s rights are protected and by all who prescribe future drugs or interventions based on that data.
There are several laws/legislation that laid the foundation for GCP, The Nuremberg Code (1947), The Declaration of Helsinki (1964), The Belmont Report (1979), International Conference on Harmonization (ICH-GCP), International Standards Organization 14155 and the Code of Federal Regulations.
In 1997, the FDA approved the GCP guidelines developed by the ICH. The ICH guidelines have been adopted into law in several countries (UK/Europe), but are used as guidance by the FDA.
