临床试验听听看 ▎ICH-GCP 4.4

药物临床试验网 · 公众号 · 药品 · 2017-05-31 16:59

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4. INVESTIGATOR 研究者
4.4 Communication with
IRB/IEC 与IRB/IEC的交流
4.4.1 Before initiating a trial, the investigator/institution should have written and dated approval/favourable opinion from the IRB/IEC for the trial protocol, written informed consent form, consent form updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects.
在开始一个试验前，研究者/研究机构应当有IRB/IEC对试验方案、知情同意书、知情同意书的更新、受试者招募程序(如广告)、以及提供给受试者的任何其他书面资料的书面的、注明日期的批准/赞成意见。
4.4.2 As part of the investigator's/institution’s written application to the IRB/IEC, the investigator/institution should provide the IRB/IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the trial, the investigator/institution should supply a copy of the updated Investigator’s Brochure to the IRB/IEC.
作为研究者/研究机构向IRB/IEC书面申请的一部分，研究者/研究机构应当向IRB/IEC提供研究者手册的当前文本。如果研究者手册在试验中更新，研究者/研究机构应当向IRB/IEC提供更新的研究者手册。
4.4.3 During the trial the investigator/institution should provide to the IRB/IEC all documents to review.
在试验期间，研究者/研究机构应当向IRB/IEC提供全部供审评的文件。