In the Trials@home consortium we explore opportunities of moving clinical trials from the traditional clinic setting to the participant’s surroundings, using digital innovations to conduct decentralised clinical trials (DCTs). Utrecht University is the academic lead for WP4 on Ethical, regulatory, GCP and Legal aspects for conducting DCTs.

The overall goal of the EMA IMPACT project is to describe and understand processes for updating clinical guidelines and the role of healthcare professional associations and public bodies involved in the production of clinical guidelines and the dissemination of emergent safety concerns. Project objectives include:
1. Identify and describe the key stakeholders, processes, roles, and responsibilities for updating clinical guidelines in six EU Member States (Denmark, Greece, Latvia, Netherlands, Portugal, Slovenia). 
2. Describe and analyse how product specific RMMs for five disease priority areas and active substances have been integrated into relevant clinical guidelines in DK, GR, LV, NL, PT and SI. 
3. Provide recommendations for regulators to engage with healthcare professional bodies and other responsible parties to strengthen the role of clinical guidelines for RMM implementation.