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What is Good Clinical Practice?

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Good Clinical Practice is a widely used term, referring to the many rules, regulations and guidelines that govern research on human beings. These rules provide us with ethical and scientific quality standards for the design, conduct, recording and reporting of trials (usually drug trials) that involve the participation of human subjects.

In this Module you will learn about the various regulations and guidelines that constitute Good Clinical Practice, but the primary purpose of all of these is for one aim - the protection of patients.

Good Clinical Practice directly affects patients by requiring that clinical trials are conducted in a way that ensures the rights, safety and welfare of the trial participants. Good Clinical Practice also has an indirect effect on future patients, by ensuring that the data generated from clinical trials are true and accurate.