中文
· 第八章 第二十六條 每個試驗(yàn)均應(yīng)當(dāng)有名稱或者代號，并在研究相關(guān)的文件資料及試驗(yàn)記錄中統(tǒng)一使用該名稱或者代號。試驗(yàn)中所采集的各種樣本均應(yīng)當(dāng)標(biāo)明該名稱或者代號、樣本編號和采集日期。 |
· 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. |
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· OECD與CFDA均要求一項(xiàng)研究應(yīng)有一個唯一代號，研究的相關(guān)文件和記錄以及產(chǎn)生的樣本均應(yīng)使用該代號，以便于識別和追溯。 · FDA則無該要求。 |
· 第八章 第三十條 參加研究的工作人員應(yīng)當(dāng)嚴(yán)格執(zhí)行試驗(yàn)方案和相應(yīng)的標(biāo)準(zhǔn)操作規(guī)程，記錄試驗(yàn)產(chǎn)生的所有數(shù)據(jù)，并做到及時、直接、準(zhǔn)確、清楚和不易消除，同時需注明記錄日期、記錄者簽名。 |
· 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 第三十條 記錄的數(shù)據(jù)需要修改時，應(yīng)當(dāng)保持原記錄清楚可辨，并注明修改的理由及修改日期、修改者簽名。 |
· 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 第三十條 電子數(shù)據(jù)的生成、修改應(yīng)當(dāng)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中一句帶過，而FDA與OECD給出詳細(xì)描述。電子數(shù)據(jù)在產(chǎn)生的當(dāng)時就應(yīng)該能夠可追溯至責(zé)任人。電子數(shù)據(jù)修改的要求也是與紙質(zhì)記錄的修改要求一致。OECD中提到審計追蹤和電子簽名，而FDA中并未出現(xiàn)這樣的名詞。CFDA中雖沒有出現(xiàn)審計追蹤和電子簽名，但是在定義中是有的。 - - · 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 第三十一條 進(jìn)行病理學(xué)同行評議工作時，同行評議的計劃、管理、記錄和報告應(yīng)當(dāng)符合以下要求： （一）病理學(xué)同行評議工作應(yīng)當(dāng)在試驗(yàn)方案或者試驗(yàn)方案變更中詳細(xì)描述； （二）病理學(xué)同行評議的過程，以及復(fù)查的標(biāo)本和文件應(yīng)當(dāng)詳細(xì)記錄并可追溯； （三）制定同行評議病理學(xué)家和專題病理學(xué)家意見分歧時的處理程序； （四）同行評議后的結(jié)果與專題病理學(xué)家的診斷結(jié)果有重要變化時，應(yīng)當(dāng)在總結(jié)報告中論述說明； （五）同行評議完成后由同行評議病理學(xué)家出具同行評議聲明并簽字注明日期； （六）總結(jié)報告中應(yīng)當(dāng)注明同行評議病理學(xué)家的姓名、資質(zhì)和單位。 - - |
歡迎各位同行進(jìn)行勘誤及指出不足之處。
參考文獻(xiàn)：
[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] 國家食品藥品監(jiān)督管理總局，藥物非臨床研究質(zhì)量管理規(guī)范，2017年9月1日生效
