No. Regardless of intent or how or from whom the information was received, suspected or known falsification or alteration of records required under parts 210, 211, and 212 must be fully investigated under the CGMP quality system to determine the effect of the event on patient safety, product quality, and data reliability; to determine the root cause; and to ensure the necessary corrective actions are taken (see §§ 211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100).

不可以。无论是意图还是收到信息的方式或对象，可疑的或已知的造假行为或记录的修改（210,211,212所要求的）必须在CGMP质量系统下充分调查以确认对病人安全、产品质量和数据可靠性影响，找出导致问题发生的根本原因；并且保证采取必要的纠正措施。（见§§211.22(a), 211.125(c), 211.192, 211.198, 211.204, and 212.100）。

FDA invites individuals to report suspected data integrity issues that may affect the safety, identity, strength, quality, or purity of drug products at DrugInfo@fda.hhs.gov. “CGMP data integrity” should be included in the subject line of the email. This reporting method is not intended to supersede other FDA reports (e.g., field alert reports or biological product deviation reports that help identify drug products that pose potential safety threats).

FDA欢迎公众举报可疑的数据完整性问题至DrugInfo@fda.hhs.gov，这些问题可能会影响药物的安全性，鉴别，效力，质量或纯度。邮箱标题应写明“CGMP 数据完整性”。该报告方法无意取代其他FDA报告（例如，有助于识别潜在安全威胁的药品的警戒报告或生物制品缺陷报告）。

16. Should personnel be trained in preventing and detecting data integrity issues as part of a routine CGMP training program?

阻止和识别数据完整性问题应作为人员CGMP常规培训计划的一部分吗？

Yes. Training personnel to prevent and detect data integrity issues is consistent with the personnel requirements under §§ 211.25 and 212.10, which state that personnel must have the education, training, and experience, or any combination thereof, to perform their assigned duties.

是的。对人员培训以阻止和发现数据完整性问题是与§§211.25和212.10中对人员的要求相一致，该法规规定人员需要具有一定的教育背景，接受过培训并具有工作经验，或者能结合以上要求以履行他们被赋予的职责