Final Statistical Analysis

The purpose of the Final Statistical Analysis stop is to perform the statistical analysis defined in the study design of all relevant data in the database. The results of the final analysis will be used to write the Clinical Study Report (CSR) and may be submitted to regulatory authorities.

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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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