released the ICH E6(R3) draft guideline for public consultation in May 2023 in collaboration with global health authorities, including the FDA. The draft revises ICH E6(R2), and regulatory ...
问：关于临床监查，E6指导原则提出了哪些要求？ 答：申办者应当建立一个系统的、优化的、基于风险的方法来监查临床试验。可以选择现场监查 ...
Among the most significant changes is the European Union’s leadership in implementing the ICH E6(R3) guidelines. These updates emphasize data integrity and traceability, setting new benchmarks for ...
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