According to ICH-GCP, section 5.19.1: “The purpose of an audit, which is independent of and separate from routine monitoring and quality control functions, should be to evaluate trial conduct and compliance with the protocol, Standard Operating Procedures (SOP), Good...
The term “quality”, when talking about clinical trials, is related to various elements and concepts. But what are the basics of quality that any clinical trial should meet? On what grounds is quality based when we talk about drug-related clinical trials?...
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