Health Products (Clinical Trials) Regulations 2016 · As enacted · Part 2 · Clinical Trials of Therapeutic Products or Applicable Ctgt Products
23. Record of clinical trials
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The sponsor and a principal investigator must keep such records of the clinical trial, in accordance with paragraph (2), as will individually and collectively —
permit proper evaluations to be made of the conduct of the trial and the quality of the data produced;
demonstrate compliance by each person involved in the trial with the principles of good clinical practice and all applicable regulatory requirements; and
in the case of an investigational product that is an applicable CTGT product, allow traceability of the product.
The records mentioned in paragraph (1) must —
be kept up‑to‑date at all times;
be available at all times for inspection by the Authority or any person authorised by the Authority in that behalf; and
be kept at least until the later or the latest, as the case may be, of the following:
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;
the expiry of 2 years after the last of such registrations is granted;
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;
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;
the expiry of such other period as the Authority may direct in any particular case.
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:
the person’s name;
the person’s qualifications;
the person’s responsibilities in the trial.
Subregulation 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 —
permit proper evaluations to be made of the conduct of the trial and the quality of the data produced;
demonstrate compliance by each person involved in the trial with the principles of good clinical practice and all applicable regulatory requirements; and
in the case of an investigational product that is an applicable CTGT product, allow traceability of the product.
Subregulation 2
The records mentioned in paragraph (1) must —
be kept up‑to‑date at all times;
be available at all times for inspection by the Authority or any person authorised by the Authority in that behalf; and
be kept at least until the later or the latest, as the case may be, of the following:
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;
the expiry of 2 years after the last of such registrations is granted;
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;
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;
the expiry of such other period as the Authority may direct in any particular case.
Subregulation 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:
the person’s name;
the person’s qualifications;
the person’s responsibilities in the trial.