Good clinical practice: issues and challenges.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials involving the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, integrity and confidentiality and well being of trial subjects are protected consistent with the principles that have their origin in the Declaration of Helsinki and that the data and reported results are credible and accurate'.