(1) A person shall not —
(a) conduct a clinical trial; or
(b) perform the functions of the sponsor of a clinical trial, whether that person is the sponsor or is acting under arrangements made with that sponsor,
otherwise than in accordance with the conditions and principles of good clinical practice specified in Schedule 2.
(2) The sponsor of a clinical trial shall put and keep in place arrangements for the purpose of ensuring that with regard to the clinical trial the conditions and principles of good clinical practice under subsection (1) are satisfied or adhered to.
(3) Subject to subsection (4), the sponsor of a clinical trial shall ensure that —
(a) the investigational medicinal products used in the clinical trial; and
(b) any devices used for the administration of such products, are made available to the subjects of the clinical trial free of charge.
(4) Where —
(a) a clinical trial is conducted at more than one trial site; and
(b) the application for authorization to conduct the clinical trial specifies that in relation to one or more trial sites the duties of the sponsor under subsections (2) and (3) are to be performed by a person other than the sponsor, those duties shall, in relation to that trial site, be performed by the person so specified.