EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.
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A newly-translated guidance document from Japan’s drug and device regulator outlines the points that clinical trial sponsors should consider when using electronic methods to collect informed consent from participants.
The EU recommendation paper on decentralized clinical trials (DCTs) marked an important “first step” on the direction the European regulatory network wants to take with DCTs. Member states are now focused on reviewing and tracking DCTs to gain experience before considering the need for any updates to the recommendation paper.
Revisions to the updated EU guideline on transitioning multinational trials to the Clinical Trials Regulation are said to be “solution oriented.”