Earlier this month, our Life Sciences Regulatory and Compliance team published a practice note in Practical Law, which explains how clinical trials are regulated in the United Kingdom.
The practice note provides an overview of the applicable legislative and regulatory framework, and role of the relevant regulatory authorities in the UK. It also:
- Outlines the process for applying for clinical trial authorisation, including pre-trial considerations.
- Explains the procedural requirements during and after the end of the clinical trial, including safety information reporting requirements.
- Contains a high-level discussion on the regulation of decentralised clinical trials in the UK and other important considerations.
For those who are less familiar with the UK’s clinical trials regulatory framework, or who are looking to refresh their understanding, please see the practice note here.