3.3 Procedures 程序
The IRB/IEC should establish, document in writing, and follow its procedures, which should include:
IRB/IEC应当建立书面文件和遵循其程序，程序应包括：
3.3.7 Specifying that no deviations from, or changes of, the protocol should
be initiated without prior written IRB/IEC approval/favourable opinion of an
appropriate amendment, except when necessary to eliminate immediate hazards to
the subjects or when the change(s) involves only logistical or administrative
aspects of the trial (e.g., change of monitor(s), telephone number(s)) (see
4.5.2).
说明在方案的适当修改预先得到IRB/IEC的书面批准/赞成之前，不能偏离或改变试验方案，除非有必要排除对于对象的直接危害，或方案的改变只涉及试验的后勤或管理方面(如更换监查员，改变电话号码)(见4.5.2)。
3.3.8 Specifying that the investigator should promptly report to the
IRB/IEC:
说明研究人员应当立即报告IRB/IEC的事项：
a) Deviations from, or changes of, the protocol to eliminate immediate
hazards to the trial subjects (see 3.3.7, 4.5.2, 4.5.4).
偏离或改变方案以消除试验对象的直接危害(见3.3.7，4.5.2，4.5.4);
b) Changes increasing the risk to subjects and/or affecting significantly the
conduct of the trial (see 4.10.2).
增加对象风险的改变和/或明显影响试验实施的改变(见4.10.2)
c) All adverse drug reactions (ADRs) that are both serious and
unexpected.
所有严重的和非预期的药品不良反应(ADR)
d) New information that may affect adversely the safety of the subjects or
the conduct of the trial.
对试验的进行或对象的安全可能不利影响的新资料。
3.3.9 Ensuring that the IRB/IEC promptly notify in writing the
investigator/institution concerning:
确保IRB/IEC迅速通知研究者/研究机构的事项：
a) Its trial-related decisions/opinions.
与试验有关的决定/建议
b) The reasons for its decisions/opinions.
IRB/IEC决定/意见的理由
c) Procedures for appeal of its decisions/opinions.
请求IRB/IEC决定/意见的程序
