Guidance on good clinical practice

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, recording and reporting trials that involve the participation of people.

Complying with GCP provides the necessary assurance that the rights, safety and wellbeing of people participating in trials are protected and that clinical-trial data are credible.

Requirements for the conduct of clinical trials in the European Union (EU), including GCP and good manufacturing practice (GMP) and GCP or GMP inspections, are implemented in:

• the 'Clinical Trial Directive' (Directive 2001/20/EC);
• the 'GCP Directive' (Directive 2005/28/EC).

Guidance on good clinical practice has been produced by the International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH).