Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. Regulatory agencies conduct GCP inspections to verify the integrity of data generated in clinical trials and to assure the protection of human research subjects, in addition to ensuring that clinical trials are conducted according to the applicable regulations. The first joint GCP workshop of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) and the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA‐UK) was held in October 2018 and provided the agencies’ perspectives on the importance of data quality management practices on data integrity. Regulatory perspectives on data blinding to minimize introduction of bias, and the role of audit trails in assessing data integrity in global clinical trials were discussed. This paper summarizes considerations of both agencies on these topics, along with case examples.

中文翻译：

---

全球临床试验中的数据完整性：美国FDA和MHRA UK联合良好临床实践研讨会的讨论。

良好临床规范（GCP）是用于设计，进行，记录和报告临床试验的国际道德和科学质量标准。监管机构进行GCP检查，以验证临床试验中生成的数据的完整性，并确保对人类研究对象的保护，此外还要确保根据适用法规进行临床试验。美国食品和药物管理局（FDA）药品评估与研究中心（CDER）和英国药品和保健产品监管局（MHRA-UK）的首次GCP联合研讨会于2018年10月举行，并提供了机构的观点数据质量管理实践对数据完整性的重要性。有关数据盲目的监管观点，以最大程度地减少偏差的产生，讨论了审计跟踪在评估全球临床试验中数据完整性方面的作用。本文总结了两个机构在这些主题上的考虑因素以及案例。