Common use of Type of Clinical Research Covered Clause in Contracts

Type of Clinical Research Covered. These Guidelines apply to injury caused to patients involved in Phase II and Phase III trials, that is to say, patients under treatment and surveillance (usually in hospital) and suffering from the ailment which the medicinal product under trial is intended to treat but for which a product licence does not exist or does not authorise supply for administration under the conditions of the trial. These Guidelines do not apply to injuries arising from Phase I studies where there is no prospect of personal benefit for the subject, whether or not they occur in hospital. Separate Guidelines for compensation exist for such studies.’ These Guidelines do not apply to injury arising from clinical trials on marketed products (Phase IV) where a product licence exists authorising supply for administration under the conditions of the trial, except to the extent that the injury is caused to a patient as a direct result of procedures undertaken in accordance with the protocol (but not any product administered) to which the patient would not have been exposed had treatment been other than in the course of the trial. These Guidelines do not apply to clinical trials which have not been initiated or directly sponsored by the company providing the product for research. Where trials of products are initiated independently by doctors under the appropriate provisions of The 2004 Medicines for Human Use (Clinical trials) Regulations (SI 2004-1031), responsibility for the health and welfare of patients rests with the doctor alone (see also paragraph 5.2 below).