24 Jul Handbook for Good Clinical Research Practice (GCP)
Clinical research is necessary to establish the safety and effective ness of specifi c health and medical products and practices. Much of what is known today about the safety and effi cacy of specifi c products and treatments has come from randomized controlled clinical trials1 that are designed to answer important scientifi c and health care questions. Randomized controlled trials form the foundation for “evidence-based medicine”, but such research can be relied upon only if it is conducted according to principles and standards collectively referred to as “Good Clinical Research Practice” (GCP).
This handbook is issued as an adjunct to WHO’s “Guidelines for good clinical practice (GCP) for trials on pharmaceutical products” (1995), and is intended to assist national regulatory authorities, sponsors, investigators and ethics committees in implementing GCP for industry sponsored, government-sponsored, institution-sponsored, or investigator-initiated clinical research. The handbook is based on major international guidelines, including GCP guidelines issued subsequent to 1995, such as the International Conference on Harmonization (ICH) Good Clinical Practice: Consolidated Guideline and is organized as a reference and educational tool to facilitate understanding and implementation of GCP by:
·describing the clinical research process as it relates to health and medical products, and identifying and explaining each of the activities that are common to most trials and the parties who are ordinarily responsible for carrying them out;
·linking each of these processes to one or more Principle(s) of GCP within this Handbook;
·explaining each GCP Principle and providing guidance on how each Principle is routinely applied and implemented;
·directing the reader to specifi c international guidelines or other references that provide more detailed advice on how to comply with GCP.