Good Clinical Practice
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is a set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with these standards provides public assurance that the rights, safety, and well-being of trial subjects are protected and that the results of the trials are credible.
Pronunciation
Good Clinical Practice: /ɡʊd ˈklɪnɪkəl ˈpræktɪs/
Etymology
The term "Good Clinical Practice" is derived from the English words "good", meaning of high quality or standard, "clinical", relating to the observation and treatment of actual patients, and "practice", the actual application or use of an idea, belief, or method.
Related Terms
- Clinical Trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
- Ethics Committee: An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.
- Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate.
- Protocol: A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.
Categories
External links
- Medical encyclopedia article on Good Clinical Practice
- Wikipedia's article - Good Clinical Practice
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