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REVIEW ARTICLE

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


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

Correspondence Address:
Zainab Mehboob Rupani,
Department of Clinical Operation and Electronic Trial Master File, Tata Consultancy Services Ltd., Rodas Enclave, Park Ln, Hiranandani Estate, Thane West - 400 607, Maharashtra
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.PICR_106_19

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.
    
 

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