"Over the last 15-18 years good clinical practice (GCP) has emerged as the framework, from the standpoint of ethical and regulatory expectations, for the conduct of biomedical clinical studies in humans. GCP is mentioned in all existing clinical trial texts, manuscripts, papers, and presentations and it has become law in a number of global regions and countries. GCP provides a practical framework for clinical trial professionals to work within and guides them to abide by regulatory requirements. In turn, the regional and country regulatory authorities integrate GCP into their clinical trial regulations, adopt it to their existing regulations, or utilize it as guidance / best practice"-- Provided by publisher.