Develop Study Report

The purpose of the Develop Study Report is to generate the Study Report from the final data analysis for submission to the Regulatory Authority for consideration.

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DCT-specific Considerations/Inputs

Include documentation of different DCT methods and any alternative site models used.


Description


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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