FDA Guidance on Clinical Trials with Decentralized Elements: Overview
The article highlights the key points related to specific types of clinical trials.
The article highlights the key points related to specific types of clinical trials.
The article highlights the key points related to specific types of clinical trials.
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.
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.
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.