FDA
The new article describes in detail specific technologies to be used for clinical trials with decentralized elements and also clarifies the roles and responsibilities of the parties involved.
FDA
The new article provides additional clarifications regarding the oversight to be conducted by the authority when it comes to clinical trials with decentralized elements, and also highlights specific aspects related to the administration of products subject to investigation.
FDA
The new article outlines certain specific aspects related to the existing legal framework, such as packaging, shipping, safety monitoring, as well as the use of electronic systems.
CDSCO
The article highlights the key points related to clinical trials and the way they should be conducted in order to ensure the accuracy and reliability of the results, as well as the safety of the patients involved.
CDSCO
The new article pays special attention to the prerequisites of a clinical trial, addressing the matters related to protocols and key elements thereof.
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