4. INVESTIGATOR 研究者
4.5 Compliance with Protocol
对试验方案的依从性
4.5.1 The investigator/institution should conduct the trial in compliance with the protocol agreed to by the sponsor and, if required, by the regulatory authority(ies) and which was given approval/favourable opinion by the IRB/IEC. The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm agreement.
研究者/研究机构应当按照申办者和(如有必要)管理当局同意、并得到IRB/IEC批准/赞成的方案实施试验。研究者/研究机构和申办者应当在方案上或另立的合同上签字，确认同意方案。
4.5.2 The investigator should not implement any deviation from, or changes of the protocol without agreement by the sponsor and prior review and documented approval/favourable opinion from the IRB/IEC of an amendment, except where necessary to eliminate an immediate hazard(s) to trial subjects, or when the change(s) involves only logistical or administrative aspects of the trial (e.g., change in monitor(s), change of telephone number(s)).
研究者在没有取得申办者同意和事先得到IRB/IEC对于一个修改的审评与书面批准/赞成时，不应当偏离或改变方案，除非必需消除试验对象的直接危害或这些改变只涉及试验的供应或管理方面(如更换监查员，改变电话号码)。
4.5.3 The investigator, or person designated by the investigator, should document and explain any deviation from the approved protocol.
研究者，或由研究者指定的人，应当记录和解释已批准方案的任何偏离。
4.5.4 The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard(s) to trial subjects without prior IRB/IEC approval/favourable opinion. As soon as possible, the implemented deviation or change, the reasons for it, and, if appropriate, the proposed protocol amendment(s) should be submitted:
为了消除对试验对象的直接危险，研究者可以没有IRB/IEC的预先批准/赞成意见偏离或改变方案。所实施的偏离或改变、改变的理由、以及所提议的方案修改尽可能地提交给：
a) to the IRB/IEC for review and approval/favourable opinion,
IRB/IEC审评并得到批准/赞成
b) to the sponsor for agreement and, if required,
申办者征得同意和，如果需要
c) to the regulatory authority(ies).
管理当局
