Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 581

Clinical Trial and GCP Standards in Selected Leading Countries/Regions
12

Q. Have any foreign Health Authorities conducted GCP inspection in Australia, and, if yes, what are the
results from these inspections?

A. Yes, the U.S. FDA has conducted fourteen (14) GCP inspections from 1989 to 2012 at Australian investigator
sites (Clinical Investigator Inspection database last searched April 2014), none of which resulted in an OAI
classification. Staff from the TGA has participated in some of these inspections as observers/trainees (personal
communication). In addition four (4) Australian investigator sites were inspected in 2011 (none resulting in OAI
classifications), but not entered into the database (personal communication).
EMA GCP inspectors have also conducted a limited number of investigator site/sponsor inspections, however,
no specific data is available other that in 2012 two (2) routine inspections in Australia/NZ according to the "Annual
report of the GCP Inspectors Working Group 2012" (EMA/627138/2012, 28 May 2013), and five (5) non-routine
and eight (8) routine inspections in 2011 in Middle East/Asia/Pacific according to "'Annual report of GCP
Inspectors Working Group 2011" (EMA/INS/GCP/972336/2011). Neither specific site classifications nor specific
countries are listed in these reports.
13

Q. Is there a certification programme for Ethics Committees in Australia?

A. Yes, there is a voluntary National Certification Scheme of Institutional Processes for Health Research Ethics
Committees (HRECs) related to the Ethical Review of Multi-Centre Research with NHMRC as the certifying body.
By the end of 2012, fifty (50) HRECs were certified under this scheme, including two (2) independent/private
not-for-profit HRECs (Bellberry Limited (SA) and Lighthouse Institutional Review Centre (WA)). Furthermore an
HREC must "notify its existence" to the Australian Health Ethics Committee (AHEC).
14

Q. Does each investigational site involved in a multi-centre trial need to gain approval from the site's
institutional Ethics Committee/HREC?

A. No, not in all cases. There is currently a process called the "National Approach" being rolled out in Australia
of a single ethical review of multi-centre research carried out at public institutions across and/or within the States
and Territories. Currently New South Wales (NSW), Queensland (QLD) and South Australia (SA) have systems in
place for intra-state single ethical review of health and medical research inclusive of clinical trials. Victoria (VIC)
has a system limited to single ethics review of multicentre clinical trials. All these states have an ethics application
process that utilizes the Online Forms website (www.ethicsform.org) where the NEAF (see below) can also be
found. Under this process a Coordination (Principal) Investigator (CI) submits, on behalf of all (institutional)
centres participating in the trial, the complete National Ethics Application Form (NEAF) to the reviewing HREC
with jurisdiction at that site and communicates the outcome of the ethical review to the individual Principal
Investigators (PIs) from the other centres involved in the trial. The PI at each centre ensures the outcome of the
ethical review and other relevant information about the proposed trial (including budget) is communicated to the
Research Governance Officer (RGO) of their institution. The RGO then assesses whether the proposed trial is
suitable and the budget is acceptable for that institution, thus in essence the RGO is the "Approving Authority," and
the trial cannot commence at this site before their approval is granted.
In addition, the VIC and QLD Departments of Health and the NSW Ministry of Health have signed a
Memorandum of Understanding (MOU) introducing interstate mutual acceptance of ethical and scientific review
in public hospitals for multicentre clinical trials being conducted in more than one of these states. Documents have
been developed the three states' health departments to support users of this interstate mutual acceptance available
from: http://www.health.vic.gov.au/cchree/about.htm.
[Editor's note: Currently, it is estimated that the institutional governance review and approval can cause a
considerable delay in individual centres' start-up time by five months or more from application to approval ("ARCS
Australia Clinical Research Governance Forum Outcomes Paper," Feb. 2013).]
Non-institutional centres (e.g., private/not-for-profit Clinical Pharmacology Units (CPUs)) can use a private/notfor-profit Central Human Research Ethics Committee, of which there are two (2) in Australia (see Q13).
15

Q. Does Ethics Committee approval need to be renewed or reauthorized during the study, and if so at
what interval?

A. According to the National Statement, Chapter 5.5 researchers should provide "at regular periods-reflecting the
581
http://www.ethicsform.org http://www.health.vic.gov.au/cchree/about.htm
Good Clinical Practice: A Question & Answer Reference Guide - May 2014

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2014
