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Essay / Importance of Good Clinical Practice - 558
Importance of GCP (Good Clinical Practice) and ICH Guidelines: GCP (Good Clinical Practice) is a set of international standards for the design, conduct, monitoring and recording clinical trials. GCP guarantees the accuracy and credibility of the results reported. It also ensures that the rights and integrity of the subject are protected and kept secret and that the data collected is reliable. Here, it is very necessary to understand the reasons that led to the formation of the GCP-ICH guidelines. The Nuremberg Code: In 1947, the Nuremberg Code was established after germination doctors were accused of conducting experiments on human subjects without their permission or consent. This code clearly stipulated that in order to conduct medical experiments on human subjects, it was necessary for them to have given their consent and to be fully aware of the risks of the experiment. The Declaration of Helsinki: In 1965, the World Medical Association (WMA) developed guidelines. for ethical principles regarding human trials. It focused on protecting the rights of human subjects. This was the basis of the ICH-GCP guideline...