Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB:
(a) enter the site of the trial; and
(b) search the site and any thing on the site; and
(c) inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), any thing on the site that relates to the trial; and
(d) take photographs, make video recordings or make sketches of the site or any thing on the site; and
(e) inspect any book, record or document on the site that relates to the trial; and
(f) request the principal investigator to:
(i) answer any questions put by the authorised officer; and
(ii) produce any book, record or document requested by the authorised officer.
(2) An authorised officer is not entitled to do a thing mentioned in subregulation (1) if:
(a) the principal investigator, or any other person present at the site concerned and in apparent control, requests the authorised officer to produce his or her identity card for inspection; and
(b) the authorised officer fails to comply with the request.
Note For identity cards, see section 52 of the Act.
(3) The principal investigator, or any other person present at the site and in apparent control, is entitled to observe a search conducted under paragraph (1) (b), but must not impede the search.
(4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.