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| T/SHSPS 002-2024 Shanghai Specification for Capacity Evaluation of Clinical Research Associate (English Version) |
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Introduction of T/SHSPS 002-2024
本文件规定了临床试验监查员能力评估标准与管理要求。
本文件适用于临床试验机构、申办者和合同研究组织(CRO)对临床试验监查员能力的评估与管理，以及为CRA个人能力提升提供参考。
在研究者发起的临床试验项目中承担任务的监查员，其能力评估可参考本规范。
Contents of T/SHSPS 002-2024