Type of Clinical Research Covered. 2.1 These Guidelines apply to injury caused to patients involved in clinical investigations, that is to say, patients under treatment and surveillance (usually in hospital) which the use of the medical device under investigation is intended to assist but where the device does not bear “CE” marking in relation to the aspect(s) under investigation.
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Samples: Investigation Agreement, www.abhi.org.uk, www.abhi.org.uk