The Danish Medicines Agency’s Guidance on the Implementation of Decentralised Elements in Clinical Trials with Medicinal Products

On 4 May 2021 the Danish Medicines Agency published the guidance on decentralised clinical trials.

Clinical trials of medicines have made rapid advances when it comes to digitalisation and decentralisation. By this is meant the use of digital tools (digital consent, electronic consultations, electronic data collection systems, wearables and other medical devices, etc.), which reduce the need for patients to attend physical appointments at a hospital unit compared to a traditional clinical trial (decentralised clinical trials, DCT).

The purpose of this guidance is to provide explicit guidelines on the implementation of decentralised elements in clinical trials with medicinal products and to illuminate any challenging areas lacking solutions to sufficiently ensure trial participants safety and trial data integrity. This guidance will remain in force after the expiry of the above-mentioned COVID 19 guidelines.

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