05 Jan Who Handbook of good clinical practice (GCP)
Clinical studies are necessary to determine the safety and effectiveness of specific health and medical products and practices. Most of what we know today comes from randomized controlled clinical trials designed to answer important scientific and healthcare questions. Randomized controlled trials form the basis of evidence-based medicine, but only when they are conducted in accordance with the principles and standards collectively referred to as good clinical practice (GCP), can such studies be reliable.
As a supplement to the World Health Organization’s good clinical practice guidelines for drug trials (GCP) (1995), this manual aims to assist national regulatory agencies, sponsors, researchers and ethics committees in implementing GCP for clinical studies sponsored by industry, government, institution or researchers. This manual is based on major international guidelines, including GCP guidelines issued after 1995, such as the International Conference on Harmonization (ICH) comprehensive guidelines on good clinical practice, and serves as a reference and educational tool organization to promote the understanding and implementation of GCP through the following ways:
·Describe the clinical research process related to health and medical products, and identify and explain each activity shared by most trials and the parties normally responsible for implementing these activities;
·Link these processes to one or more of the GCP principles in this manual;
·Explain each GCP principle and provide guidance on the daily application and implementation of each principle;
·An international guide or other reference that guides readers to specify how to comply with GCP’s more detailed recommendations.