4.10 Progress Reports 进展报告
4.12 Premature Termination or Suspension of a Trial
试验中止或暂停
If the trial is prematurely terminated or suspended for any reason, the
investigator/institution should promptly inform the trial subjects, should
assure appropriate therapy and follow-up for the subjects, and, where required
by the applicable regulatory requirement(s), should inform the regulatory
authority(ies). In addition:
如果一个试验因为任何理由过早的停止或暂停，研究者/研究机构应当迅速通知试验受试对象，应当保证受试对象的合适治疗和随访，和根据适用的管理要求应当通知管理当局。另外：
4.12.1 If the investigator terminates or suspends a trial without prior
agreement of the sponsor, the investigator should inform the institution where
applicable, and the investigator/institution should promptly inform the sponsor
and the IRB/IEC, and should provide the sponsor and the IRB/IEC a detailed
written explanation of the termination or suspension.
如果研究者未与申办者事先协议便中止或暂停一个试验，研究者应当通知研究机构，研究者/研究机构应当立即通知申办者和IRB/IEC提供中止或暂停试验的详细书面解释。
4.12.2 If the sponsor terminates or suspends a trial (see 5.21), the
investigator should promptly inform the institution where applicable and the
investigator/institution should promptly inform the IRB/IEC and provide the
IRB/IEC a detailed written explanation of the termination or suspension.
如果申办者中止或暂停一个试验(见5.21)，研究者应当立即通知研究机构，研究者/研究机构应立即通知IRB/IEC并向IRB/IEC提供中止和暂停的详细书面解释。
4.12.3 If the IRB/IEC terminates or suspends its approval/favourable
opinion of a trial (see 3.1.2 and 3.3.9), the investigator should inform the
institution where applicable and the investigator/institution should promptly
notify the sponsor and provide the sponsor with a detailed written explanation
of the termination or suspension.
如果IRB/IEC终止或暂停它对一个试验的批准/赞成意见(见3.12和3.3.9)，研究者应当通知研究机构，研究者/研究机构应当立即通报申办者并提供终止或暂停的详细书面解释。
