临床试验的知情同意与SAE审查-南京鼓楼医院.pptVIP

问题1 Examples, liver failure due to diffuse hepatic necrosis occurring in a subject without any underlying liver disease would be an unexpected adverse event (by virtue of its unexpected nature) if the protocol-related documents and other relevant sources of information did not identify liver disease as a potential adverse event. 弥漫性肝坏死，没有基础肝脏疾病，方案等没有提及导致肝损 liver failure due to diffuse hepatic necrosis occurring in a subject without any underlying liver disease would be an unexpected adverse event (by virtue of its unexpected greater severity) if the protocol-related documents and other relevan