Insurance and compensation in the event of injury in Phase I clinical trials
The guidance, which has been developed in consultation with the Department of Health and the National Research Ethics Service (NRES) within the Health Research Authority (HRA), is for trials including first-in-man studies involving healthy volunteers. The guidance also applies to studies conducted in patient volunteers without the target disease to provide additional pharmacokinetic data about the medicine under research.
- Clinical research
Last modified: 20 September 2023
Last reviewed: 20 September 2023