Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) An authorised officer may, in relation to a clinical trial mentioned in regulation 12AB or column 2 of item 3 of the table in Schedule 5A:
(a) enter a 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.