临床试验听听看 ▎ICH GCP 4.9.1-4.9.3

药物临床试验网 · 公众号 · 药品 · 2017-07-21 17:00

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4.9 Records and Reports 记录和报告
4.9.1 The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
研究者应当保证给申办者的病历报告表(CRF)和所有需要的报告中的数据的准确性、完整性、易辩性和及时性。
4.9.2 Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
CRF中来自源文件的数据应当与源文件一致，如有不一致应作出解释。
4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e. an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections.
CRF中数据的任何改变或变更，应当注明日期、姓名首字母和说明(如有必要)，并应当使原来的记录依然可见(即应保留核查痕迹);这同样适用于文字和电子的改变或更正(见5.18.4(n))。申办者应当向研究者和/或研究者指定的代表提供关于进行这种更正的指南。申办者应当有书面的程序以保证在CRF中由申办者指定的代表作出的改变或更正是有记录的、有必要的，并得到研究者的认可。研究者应当保留改变和更正的记录。