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Final Data Cleaning and Database Lock

The purpose of the Final Data Cleaning and Database Lock stop is to perform any last cleansing/correction of the database and lock it from further modification.

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Description

DCT-specific Considerations/Inputs

 

Tools

Regulatory Documents

FDA/U.S.

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

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Europe/EMA

EMA Recommendation on Decentralized Elements in Clinical Trials

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Reference Documents

TransCelerate Modernizing Clinical Trial Conduct Solutions

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