Insurance and compensation in the event of injury in Phase I clinical trials

Insurance and compensation in the event of injury in Phase I clinical trials
Publication date:  28/06/2012
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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.

Document size: 65KB



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