Approving Clinical Investigations in the UK

2nd April 2026

Summary:
The UK government has published guidance detailing how to apply for approval to carry out clinical investigations, including the regulatory requirements and documentation needed. It explains the roles of regulators, ethics committees and sponsors, and sets out the steps required to ensure investigations are conducted safely and in line with legal and ethical standards. The guidance is intended to support applicants in navigating the approval process efficiently while maintaining high standards of participant protection and data quality.

Link: https://www.gov.uk/government/publications/approving-clinical-investigations

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