临床试验听听看 ▎ICH-GCP 3.4

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3.4 Records 记录 The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and correspondence) for a period of at least 3 years after completion of the trial and make them available upon request from the regulatory authority(ies). IRB/IEC应当保留全部有关记录(如书面的程序，成员名单，成员的职业/联系表，提交的文件，会议记录，以及往来信件)至完成试验后至少3年，并在管理当局需要时可以提供其书面程序和成员名单。 The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. 研究者、申办者和管理当局可向机构审查委员会/伦理委员会要求其提供书面运作程序和成员名单。 ………………………………