Good Clinical Practice (GCP) are governed by European right. They “guarantee rights, safety, and protection of subjects who take part in investigations as well as the credibility and confidentiality of personal data and investigation findings. Credibility means here integrity, authenticity, precision, accuracy, and possibility to check.
The GCP are a set of quality standards in science and ethics. They are recognized at international level, and must be observed for planning, implementation, conduct, follow-up, quality control, audit, data collection, analysis and expression of findings of biomedical investigations that study medicine for human use.”
The complete GCP are available on website Legifrance which lists all legal documents.
Those GCP that are a guarantee of exigency, and the Nancy CIC-IT staff are trained and perfectly control them.