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| DB32/T 4975-2024 Requirements of ethical management of biological samples in clinical trials (English Version) |
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Detail of DB32/T 4975-2024
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Introduction of DB32/T 4975-2024
本文件确立了临床试验生物样本伦理管理的总体要求，提供了管理体系、知情同意、伦理审查、隐私和保密方面的指导。
本文件适用于申办者发起的涉及生物样本的药物和医疗器械（含体外诊断试剂）等临床试验伦理管理。研究者发起的临床研究生物样本伦理管理可参照执行。
Contents of DB32/T 4975-2024