The purpose of this guidance is to illuminate any challenging areas lacking solutions to sufficiently ensure trial participant's safety and trial data integrity.
This guidance reflects the challenges raised in clinical trial applications, scientific advice, our dialogue forum on decentralized clinical trials, other inquiries as well as challenges emerging in the ongoing collaboration with national, European, and international partners.
The new guidance is effective from 04 May 2021.
Guideline for applications for authorisation of clinical trials of medicinal products in humans is detailed step by step in DMA website.