4Definitions

4 Definitions

Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) medical device;
(b) Secretary; and
(c) therapeutic goods.

In this instrument:

Act means the Therapeutic Goods Act 1989.

approving authority, in relation to a clinical trial of therapeutic goods, means a person, body or organisation:

(a) at whose site the clinical trial, or part of the clinical trial, is being conducted; and
(b) who is responsible for the governance of the clinical trial, other than in relation to those matters within the remit of the responsible ethics committee, at that site.

authorised officer has the same meaning as in the Regulations.

MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

National Statement means the National Statement on Ethical Conduct in Human Research published by the National Health and Medical Research Council, as in force or existing at the commencement of this instrument.

Note: The National Statement is published on the internet at www.nhmrc.gov.au.

Practice Guideline means the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) published by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), as in force or existing at the commencement of this instrument.

Note: The Practice Guideline is published on the internet at www.ich.org and may be accessed through www.tga.gov.au.

procedural protocol, otherwise known as trial protocol, in relation to a clinical trial of therapeutic goods, means the protocol that describes the objectives, design, methodology, statistical considerations and organisation of the clinical trial.

Regulations means the Therapeutic Goods Regulations 1990.

relevant authorised officer, in relation to a clinical trial of therapeutic goods, means:

(a) the authorised officer who has exercised powers in accordance with regulation 12AC of the Regulations in relation to the clinical trial; or
(b) the authorised person who has exercised powers in accordance with regulation 7.4 of the MD Regulations in relation to the clinical trial.