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Record of clinical trials

Health Products (Clinical Trials) Regulations 2016

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—(1) The sponsor and a principal investigator must keep such records of the clinical trial, in accordance with paragraph (2), as will individually and collectively —(a)permit proper evaluations to be made of the conduct of the trial and the quality of the data produced;(b)demonstrate compliance by each person involved in the trial with the principles of good clinical practice and all applicable regulatory requirements; and(c)in the case of an investigational product that is an applicable CTGT product, allow traceability of the product.(2) The records mentioned in paragraph (1) must —(a)be kept up‑to‑date at all times;(b)be available at all times for inspection by the Authority or any person authorised by the Authority in that behalf; and(c)be kept at least until the later or the latest, as the case may be, of the following:(i)the date where there is no more pending or contemplated application for registration under the Act of the therapeutic product or applicable CTGT product being tested in the clinical trial;(ii)the expiry of 2 years after the last of such registrations is granted;(iii)where the clinical trial is terminated, the expiry of 2 years after the Authority has been informed of the termination of the trial under regulation 12;(iv)the expiry of 6 years after the conclusion of the clinical trial;(iva)where the record is of a clinical trial that involves an applicable CTGT product and relates to the traceability of that product — the expiry of 30 years after the expiry date of that product or any other shorter period that the Authority allows in a particular case;(v)the expiry of such other period as the Authority may direct in any particular case.(3) Without limiting the generality of paragraph (1), the principal investigator must maintain a record of every person assisting the principal investigator in the clinical trial, containing all of the following information:(a)the person’s name;(b)the person’s qualifications;(c)the person’s responsibilities in the trial.

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