The Regulations state that provision must be made for insurance or indemnity to cover the liability of the investigator and sponsor which may arise in relation to the clinical trial.
Where the Chief Investigator is employed by an NHS Trust, clinical negligence is provided via the NHS Indemnity Scheme once Trust R&D approval has been received. Further details can be found here: NHS Indemnity Arrangements
Trials where the Chief Investigator is employed by KCL will be sponsored or co-sponsored by the College and will require additional indemnity cover; this is provided by the College Insurance Policy. This SOP describes the process to be followed to obtain insurance and indemnity for clinical trials sponsored or co-sponsored by KCL.