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1.临床试验研究应说明试验程序是否经所在单位或地区伦理学相关机构的批准,研究对象或其亲属是否知情同意并签署知情同意书。2.观察对象为患者时,需注明病例和对照者来源、选择标准及一般情况等,必要时还应说明剔除标准。临床随机对照研究应交待干预方法的设计(随机方法)和所采用的盲法。研究对象为实验动物时,需注明动物的名称、种系、等级、数量、来源、性别、年龄、体重、饲养条件和健康状况等。
1. Clinical trial studies should indicate whether the test procedure is approved by the institution (s) or regional ethics body concerned and whether the subject or his relatives have informed consent and signed informed consent. 2. Observe the object for the patient, indicate the source of cases and controls, selection criteria and general situation, if necessary, should also indicate the removal criteria. Clinical randomized controlled trials should address the design of the intervention method (randomized approach) and the blinded approach used. When the research object is an experimental animal, the name, germline, grade, quantity, origin, sex, age, weight, breeding conditions and health status of the animal shall be indicated.