A Review of EMA Recommendations on Decentralized Clinical Trial Elements

In Signant’s white paper, our in-house experts summarize key themes from an EMA recommendation paper on the use of decentralized elements in clinical trials for regulatory submission, including remote informed consent and direct-to-patient medication provision.

These recommendations go beyond the extent of the temporary guidance introduced to address COVID-19.

Readers will learn how to leverage perspectives from patients and patient organizations to determine the selection or feasibility of decentralized elements in study designs, maintain reliable, high-quality data when using remote data capture methods, appropriately delegate site and investigator responsibilities, and more.

Read our white paper for an overview.