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What is the purpose of quality management standards for drug clinical trials?
Ensure that the clinical trial process of drugs is standardized, the results are scientific and reliable, the rights and interests of subjects are protected, and the safety is guaranteed.
According to Baidu question bank, the main purpose of quality management standards for drug clinical trials is to ensure that the process of drug clinical trials is standardized, the results are scientific and reliable, the rights and interests of subjects are protected and the safety is guaranteed. It plays an important role in ensuring the implementation quality of clinical trials and protecting the rights and interests of subjects.
The quality management standard of drug clinical trial is the quality standard of the whole process of drug clinical trial, including scheme design, organization and implementation, supervision, inspection, recording, analysis, summary and report.
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