Regulatory Reporting

The purpose of the Regulatory Reporting stop is to submit the results of the Clinical Trial to the Regulatory Authority aligned to the agreed-upon regulatory review processes. 

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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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