Updated guidance on the implementation of decentralised elements in clinical trials with medicinal products

You can now read the updated guidance on the implementation of decentralised elements in clinical trials with medicinal products

We are happy to announce that the guidance on the implementation of decentralised elements in clinical trials is now available in version 2.0.

The guidance have been thoroughly adjusted and introduces the new possibility of implementing Remote Source Data Verification (rSDV) processes. You can find an overview of the most important changes in the guidance’s change log.

We encourage all stakeholders to send comments, input or questions to the inbox for clinical trials, which will help to further develop the framework of conducting decentralised clinical trials.