临床试验的知情同意与SAE审查.PPT

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 relevant sources of information only referred to elevated hepatic enzymes or hepatitis as potential adverse events related to the procedures involved in the research. 弥漫性肝坏死，没有基础肝脏疾病，方案提及转氨酶升高 How to determine which adverse events are unanticipated problems? Assessing whether an adverse event is unexpected Assessing whether an adverse event is related or possibly related to participation in research Assessing whether an adverse event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized 问题2 Adverse events may be caused by one or more of the following: (1) the procedures involved in the research; 研究程序 (2) an underlying disease, disorder, or condition of the subject; or 基础疾病 (3) other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject. 与研究和基础疾病都无关的其他情况 In general, adverse events that are determined to be at least partially caused by (1) would be considered related to participation in the research whereas adverse events determined to be solely caused by (2) or (3) would be considered unrelated to participation in the research. 问题2 Examples, subjects with cancer participating in oncology clinical trials testing chemotherapy drugs, neutropenia and anemia are common adverse events related to participation in the research. Likewise, if a subject with cancer and diabet