(1)

For subparagraph 7.3 (2) (b) (ii) and subject to subregulation (2), an authorised person may do any of the following things in relation to a clinical trial of a kind of medical device that has been approved for use solely for experimental purposes in humans:

(a)

enter the site of the trial;

(b)

search the site and anything on the site;

(c)

inspect, examine, take measurements of, or conduct tests on (including by the taking of samples), anything on the site that relates to the trial;

(d)

take photographs, make video recordings or make sketches of the site or anything on the site;

(e)

inspect any book, record or other document on the site that relates to the trial;

(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.

(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.