Importance Of Good Clinical Practices

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Importance of GCP (good clinical practice) and ICH guidelines: GCP (Good Clinical practice) is an international standard set for designing, conducting, monitoring and recording of clinical trials. GCP guaranties the accuracy and credibility of the reported results. It also assures that the rights and integrity of the subject are protected and kept secret, and the collected data is reliable. Here it is very necessary to understand the reasons that led to the formation of GCP-ICH guidelines. The Nuremberg code: in the year 1947, Nuremberg code was set after germen doctors were charged for conducting experiments on human subjects without their permission or consent. This code clearly stated that for conducting medical experiments on human subjects it is necessary that they have given their consent and that they are fully aware of the risks of 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. It was the basis of ICH-GCP guideline...

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