Regulation 28 Good clinical practice and protection of clinical trial participantsF6

(1)

No person shall—

(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.

F1(1A)

The conditions and principles of good clinical practice include those in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time.

(1B)

For the avoidance of doubt—

(a)

the functions of the sponsor include functions in relation to—

(i)

the development and maintenance of trial specific computerised systems, and

(ii)

the selection and oversight of a laboratory in relation to the analysis or evaluation of human samples collected as part of the clinical trial; and

(b)

conducting a trial includes the analysis or evaluation of human samples collected as part of the clinical trial.

(2)

Subject to paragraph (5), the sponsor of a clinical trial shall put and keep in place arrangements for the purpose of ensuring that with regard to that trial the conditions and principles of good clinical practice are satisfied or adhered to.

(3)

Subject to paragraphs (4) and (5), the sponsor of a clinical trial shall ensure that—

(a)

the investigational medicinal products used in the trial, and

(b)

any devices used for the administration of such products,

are made available to the F2participants of the trial free of charge.

(4)

The restriction in paragraph (3) shall not apply in relation to any charge payable by a F3participant under regulations made under—

(a)

the National Health Service Act 1977 M1;

(b)

the National Health Service (Scotland) Act 1978 M2; or

(c)

the Health and Personal Social Services (Northern Ireland) Order 1972 M3,

in respect of any medicinal products or devices provided in pursuance of those Acts or that Order.

(5)

If—

(a)

a clinical trial is conducted at more than one trial F4location; and

(b)

the request for authorisation to conduct that trial specifies that in relation to one or more trial F5locations the duties of the sponsor under paragraphs (2) and (3) are to be performed by a person other than the sponsor,

those duties shall, in relation to that location or those locations, be performed by the person so specified.

Annotations

Textual amendments

F1: Reg. 28(1A)(1B) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(3)
F2: Word in reg. 28(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(4)
F3: Word in reg. 28(4) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(5)
F4: Word in reg. 28(5) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(6)(a)
F5: Word in reg. 28(5) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(6)(b)
F6: Word in reg. 28 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(2)

Marginal citations

M1: 1977 c. 49.
M2: 1978 c. 29.
M3: S.I. 1972/1265 (N.I. 14).