Therapeutic Goods Regulations 1990

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:

enter a site of the trial; and

search the site and any thing on the site; and

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

take photographs, make video recordings or make sketches of the site or any thing on the site; and

request the principal investigator to:

answer any questions put by the authorised officer; and

produce any book, record or document requested by the authorised officer.

To avoid doubt, a reference to a thing in paragraph (b), (c) or (d) includes a reference to a book, record or document.

An authorised officer is not entitled to do a thing mentioned in subregulation (1) if:

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

the authorised officer fails to comply with the request.

For identity cards, see regulation 46AA.

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.

Subregulation (3) does not prevent 2 or more areas of the site being searched at the same time.