中文
· 第八章 第二十六条 每个试验均应当有名称或者代号，并在研究相关的文件资料及试验记录中统一使用该名称或者代号。试验中所采集的各种样本均应当标明该名称或者代号、样本编号和采集日期。 |
· Section II 8.3.1. A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study. |
- |
· OECD与CFDA均要求一项研究应有一个唯一代号，研究的相关文件和记录以及产生的样本均应使用该代号，以便于识别和追溯。 · FDA则无该要求。 |
· 第八章 第三十条 参加研究的工作人员应当严格执行试验方案和相应的标准操作规程，记录试验产生的所有数据，并做到及时、直接、准确、清楚和不易消除，同时需注明记录日期、记录者签名。 |
· 58.130 (a) The nonclinical laboratory study shall be conducted in accordance with the protocol. (e) All data generated during the conduct of a nonclinical laboratory study, except those that are generated by automated data collection systems, shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data. |
· Section II 8.3.2. The study should be conducted in accordance with the study plan. 8.3.3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated. |
· 要求一致。 |
· 第八章 第三十条 记录的数据需要修改时，应当保持原记录清楚可辨，并注明修改的理由及修改日期、修改者签名。 |
· 58.130 (e) Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. |
· Section II 8.3.4. Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change. |
· 要求一致。 |
· 第八章 第三十条 电子数据的生成、修改应当符合以上要求。 |
· 58.130 (e) In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input. Any change in automated data entries shall be made so as not to obscure the original entry, shall indicate the reason for change, shall be dated, and the responsible individual shall be identified. |
· Section II 8.3.5. Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given. |
· 要求一致。 · CFDA中一句带过，而FDA与OECD给出详细描述。电子数据在产生的当时就应该能够可追溯至责任人。电子数据修改的要求也是与纸质记录的修改要求一致。OECD中提到审计追踪和电子签名，而FDA中并未出现这样的名词。CFDA中虽没有出现审计追踪和电子签名，但是在定义中是有的。 - - · 58.130 (b) The test systems shall be monitored in conformity with the protocol. (c) Specimens shall be identified by test system, study, nature, and date of collection. This information shall be located on the specimen container or shall accompany the specimen in a manner that precludes error in the recording and storage of data. (d) Records of gross findings for a specimen from postmortem observations should be available to a pathologist when examining that specimen histopathologically. · 第八章 第三十一条 进行病理学同行评议工作时，同行评议的计划、管理、记录和报告应当符合以下要求： （一）病理学同行评议工作应当在试验方案或者试验方案变更中详细描述； （二）病理学同行评议的过程，以及复查的标本和文件应当详细记录并可追溯； （三）制定同行评议病理学家和专题病理学家意见分歧时的处理程序； （四）同行评议后的结果与专题病理学家的诊断结果有重要变化时，应当在总结报告中论述说明； （五）同行评议完成后由同行评议病理学家出具同行评议声明并签字注明日期； （六）总结报告中应当注明同行评议病理学家的姓名、资质和单位。 - - |
欢迎各位同行进行勘误及指出不足之处。
参考文献：
[1] US FDA Good Laboratory Practice Regulations 21 CFR 58，effective June 20, 1979 and subsequent amendments
[2] OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C (97)186/Final]
[3] 国家食品药品监督管理总局，药物非临床研究质量管理规范，2017年9月1日生效
