Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(1) Subject to subregulation (2), an authorised person may do any of the following things in relation to a clinical trial mentioned in regulation 7.3 or in item 2.3 of the table in Part 2 of Schedule 4:
(a) enter a site of the trial;
(b) search the site and any thing on the site;
(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;
(d) take photographs, make video recordings or make sketches of the site or any thing on the site;
(f) request the principal investigator of the trial to:
(i) answer any question asked by the authorised person; or
(ii) produce any book, record or other document requested by the authorised person.
Note: To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.
(2) An authorised person 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 person to produce his or her identity card for inspection; and
(b) the authorised person fails to comply with the request.
Note: See section 52 of the Act in relation to identity cards.
(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 obstruct the search.
(4) Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.