Insurance for clinical trials
Whilst there is no legal requirement to take out insurance when engaging in clinical trials, the EU Clinical Trials Directive 2001/20/EC does state that there has to be sufficient funding to provide indemnity should there be any bodily injury or property damage to any research subject who is taking part. Insurance is used provide confirmation of indemnity.
Insurance cover for clinical trials is available via a number of different insurers and is split into two parts:
- Agreed Compensation cover – compensation agreed under the applicable Clinical Trials Compensation guidelines
- Legal Liability cover – damages and defence and claimants costs that you are legally liable to pay.