Study Medication and Reconciliation

The purpose of the Study Medication and Supply Reconciliation is to ensure that any unused medications or study supplies are accounted for and returned to the appropriate source.

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DCT-specific Considerations/Inputs

If DTP services were used Drug accountability processes may change

If devices were provisioned, ensure return processes are in place for both patients and sites.


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 Direct to Patient Shipping Process Framework

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TransCelerate Modernizing Clinical Trial Conduct Solutions

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