Regulation 31A Trial master file and archivingF1

(1)

The sponsor shall keep a trial master file for a clinical trial.

(2)

The sponsor shall ensure that the trial master file is readily available at all reasonable times for inspection by the licensing authority or any person appointed by the sponsor to audit the arrangements for the trial.

(3)

The master file shall at all times contain the essential documents relating to that clinical trial.

(4)

The essential documents relating to a clinical trial are those which—

(a)

enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and

(b)

show whether the trial is, or has been, conducted in accordance with the F2relevant requirements of F3these Regulations.

(5)

The essential documents shall contain information specific to each phase of the trial.

(6)

The sponsor shall ensure that any alteration to a document contained, or which has been contained, in the trial master file shall be traceable.

(7)

F4Subject to paragraph (7A), the sponsor and the chief investigator shall ensure that the documents contained, or which have been contained, in the trial master file F5(including documents contained in electronic form) are retained for at least F6the period of 25 years beginning with the day after the conclusion of the trial and that during that period are—

(a)

readily available to the licensing authority on request; and

(b)

complete and legible.

(F77A)

If, at the date of the expiry of the 25 years referred to in paragraph (7), the data generated by the trial is being used to support an application for a UK marketing authorization, the sponsor shall ensure the documents referred to in paragraph (7) are retained for at least the period of 2 years beginning with the day after the grant of that UK marketing authorization.

(8)

The sponsor and chief investigator shall ensure that the medical files of trial F8participants are retained for at least F9the period of 25 years beginning with the day after conclusion of the trial, or such period as is required by any other enactment, if longer.

(9)

The sponsor shall appoint named individuals within his organisation to be responsible for archiving the documents which are, or have been, contained in the trial master file and, subject to paragraph (2), access to those documents shall be restricted to those appointed individuals.

(10)

If there is transfer of ownership of data or documents connected with the clinical trial—

(a)

the sponsor shall record the transfer; and

(b)

the new owner shall be responsible for data retention and archiving in accordance with paragraphs (2), (7) and (8).

(11)

For the purposes of this regulation, an individual is an individual within the sponsor’s organisation where—

(a)

he is employed or engaged by the sponsor;

(b)

he is acting under arrangements made with the sponsor for the purposes of managing or conducting the clinical trial;

(c)

where the sponsor is an individual, he is the sponsor; or

(d)

where the sponsor is a body of persons, he is—

(i)

a member of the body, or

(ii)

employed or engaged by such a member.

Annotations

Textual amendments

F1: Reg. 31A inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 18
F2: Word in reg. 31A(4)(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 13(a); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in reg. 31A(4)(b) substituted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 13(b); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in reg. 31A(7) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(2)(a)
F5: Words in reg. 31A(7) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(2)(b)
F6: Words in reg. 31A(7) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(2)(c)
F7: Reg. 31A(7A) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(3)
F8: Word in reg. 31A(8) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(4)(a)
F9: Words in reg. 31A(8) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 22(4)(b)