clinical trial compensation guidelines

Abstract

Guidelines produced by the ABPI; according to which compensation should be paid when the injury was attributable to the medicinal product or any procedure provided for by the protocol, for the more serious injury of an enduring and disabling character (not for temporary pain or discomfort), for injuries caused by procedures adopted to deal with adverse reactions to a product under trial, regardless of whether the reaction was foreseeable or predictable or whether the patient is able to prove negligence of the company; → see also insurance.