The ethics and scientific quality of human clinical trials are regulated by international standards set by the International Conference on Harmonization (ICH) in the form of guidelines known as Good Clinical Practice (GCP).
These guidelines are accepted worldwide and must be followed during any study involving human subjects. Adherence to GCP ensures the protection of the rights and safety of the participants and facilitates mutual acceptance of clinical data from one research centre to another.
The main objectives of GCP are to:
- Ensure the protection of the rights, safety and well-being of subjects participating in clinical studies
- Guarantee scientific quality and reliability of studies and respect of ethics
- Promote harmonization of clinical studies worldwide according to the requirements of regulatory agencies
- Standardize test methods