临床试验听听看 ▎ICH GCP 4.9.4-4.9.7

药物临床试验网 · 公众号 · 药品 · 2017-07-27 09:41

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4.9 Records and Reports 记录和报告
4.9.4 The investigator/institution should maintain the trial documents as specified in Essential Documents for the Conduct of a Clinical Trial (see 8.) and as required by the applicable regulatory requirement(s). The investigator/institution should take measures to prevent accidental or premature destruction of these documents.
研究者/研究机构应当按《实施临床试验的基本文件》(见8.)所述和适用管理要求保存试验文件。研究者/研究机构应当采取措施防止这些文件的意外或过早破坏。
4.9.5 Essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained (see 5.5.12).
基本文件应当保留到最后批准在一个ICH地区上市后至少2年，和直到最后在一个ICH地区没有未决的或仍在考虑的上市应用，或试验用药品的临床研究正式停止后至少已过去2年。但是，如果适用的管理要求需要或申办者签署的协议需要，这些文件应当被保存更长时间。申办者有责任通知研究者/研究机构，到什么时候这些文件不必再保存(见5.5.12)
4.9.6 The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.
试验的财务方面事宜应在申办者与研究者/研究机构的协议书中说明。
4.9.7 Upon request of the monitor, auditor, IRB/IEC, or regulatory authority, the investigator/institution should make available for direct access all requested trial-related records.
根据监查员、稽查员、IRB/IEC或管理当局的要求，研究者/研究机构应当提供他们查阅所需的与试验有关的全部记录。