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Informatics infrastructure in a rural pediatric clinical trials network: Matching specific clinical research needs with best practices and industry guidelines.农村儿科临床试验网络中的信息学基础设施：将特定的临床研究需求与最佳实践和行业指南相匹配。
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临床试验主文件迁移：迈向集中式电子试验主文件的既定步骤。

Clinical trial master file migration: A preordained step for a centralized electronic trial master file.

作者信息

Rupani Zainab Mehboob

机构信息

TATA Consultancy Services, Life Science Unit- Clinical Operations and Electronic Trail Master File, Thane, Maharashtra, India.

出版信息

Perspect Clin Res. 2020 Oct-Dec;11(4):139-143. doi: 10.4103/picr.PICR_106_19. Epub 2020 May 7.

DOI:10.4103/picr.PICR_106_19
PMID:33489830
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7819366/
Abstract

The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.

摘要

以具有成本效益的方式加快临床试验流程的需求、数据完整性重要性的提高以及确保及时符合关于试验主文件（TMF）的监管要求更新，使得制药行业明确了维护具有质量控制的集中式TMF的要求。随着使用集中式电子TMF（eTMF）的申办者数量呈指数级增长，这一趋势转变对TMF领域的数据迁移需求产生了积极影响。为了服务于处理迁移项目的读者，本文综述讨论了临床试验中临床操作和eTMF的数据迁移要求、可考虑用于避免预期障碍的可能技术以及其他一些要点。本文还重点关注迁移后应采取的步骤，以确保在监管合规方面满足迁移数据的质量要求。