CLINICAL TRIALS ADVISORY COMMITTEE
TERMS OF REFERENCE
STRUCTURE
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Background
Consistent with the ongoing work of clinical trials reform, it has been proposed that this
Committee is established to ensure the authority, expertise and representation necessary
to expedite progression of the work program.
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Purpose
The Committee will provide advice to the Department of Health and the Department of
Industry on the work program to progress implementation of each of the elements for
clinical trials reform.
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Principles
The Committee will seek to collaborate in the delivery of work relevant to clinical trials
reform through networking and communication. For this to be achieved, the Committee
will operate to:
1. share knowledge relevant to the clinical trials reform work program;
2. ensure that advice and expertise is provided from various perspectives;
3. provide avenues for collaboration to progress each element of the work program.
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Ministerial Oversight
The Committee will be co-chaired by the Department of Health and Department of
Industry. The co-Chairs of the Committee will report to the Ministers for Health and
Industry on the activities of the Committee and to Pharmaceutical Industry Working
Group.
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Chair
The Head of Division/First Assistant Secretary from the relevant business areas within
the Department of Industry and the Department of Health will co-Chair the Committee.
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Membership
The Committee will comprise of senior representatives from Commonwealth, State and
Territory Government agencies, industry, health consumer organisations and the clinical
research community.
Commonwealth Government representatives should be at the Branch Head level and
drawn from the Industry and Health departments, National Health and Medical Research
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Council and Therapeutic Goods Administration. The States and Territories will be
represented on the Committee at a level equivalent to Commonwealth members. Senior
representatives from Industry, health consumer organisations and the clinical research
community will be represented on the Committee.
Members will be formally invited to be on the Committee and expected to attend
meetings.
If required, the Chairs of the Committee can invite individuals to attend meetings on an
ad hoc basis to provide specialist input.
Members may not delegate their attendance at meetings. In exceptional circumstances,
the Chair may grant the attendance of an observer with 48 hour notice prior to the
meeting. Members may invite their associates to attend a meeting, following prior
notification to the Chairs.
Membership of the Committee will be nominally for a two-year term, but will be
reviewed annually at the end of the financial year to ensure it remains appropriate for the
implementation of the clinical trials initiative.
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Stakeholder Consultation
The Committee will foster awareness and uptake of opportunities presented by the work
elements to the wider clinical trials community, states and territories, health consumers
and the public in general.
GENERAL ISSUES
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Frequency and format of Meetings
It is expected that the Committee will meet quarterly, with a minimum of four meetings
per year. Meetings can be held either face to face or by teleconference.
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Secretariat
To be provided by the Industry department.
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Confidentiality
Information disclosed within the Committee will be treated as confidential unless agreed
otherwise (e.g. for consultation and information dissemination).
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Conflict of Interest
Members will be required to declare any conflicts of interest and conflict of interest
declarations will be a standing agenda item at all meetings.
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Agenda
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An agenda will be developed by the Industry department in consultation with members
and circulated in advance of each meeting.
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Out of Session Business
Business can be conducted out of session by telephone or electronically.
ADMINISTRATION
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Communiqué
An overview of key outcomes of the meeting discussions will be written and circulated
by the Department of Industry to the Committee after each meeting and published on the
Department of Industry website. The Secretariat will circulate the Communique two
weeks after the meeting for ratification by members, prior to publication.
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Reporting Requirements
The co-Chairs of the Committee will report on the activities of the Committee at PIWG
meetings, which is chaired by the Ministers for Health and Industry.
The Clinical Trials Advisory Committee outcomes and progress will be reported to
relevant Ministers directly through the relevant departments.
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