Guidelines for clinical trials for Victorian public health services ...

CLINICAL TRIALS –
Insurance and Risk
Management Guidelines
for Clinical Trials conducted under the Therapeutic
Goods Administration Clinical Trial Notification (CTN)
and Clinical Trial Exemption (CTX) schemes
Version 2
September 2012

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Application of the Guidelines pg 2
Quick Reference Guide, pg 3
Clinical Trials Governance, pg 4
Streamlined System for ethical
and scientific review of multi-site
research in Victoria, pg 5
Clinical Trials Sponsorship
Table 2, pg 7
VMIA Minimum Insurance
Requirements for Commercially
Sponsored Clinical Trials, pg 8
Previously agreed Schedule 7 /
Schedule 4 amendments, pg 19
Disclosure Obligations, pg. 21
Clinical Trials Advice Form, pg 22
Key References, Standard Forms
& Templates, pg 27
Attachment 1, Clinical Trials Advice
Form, pg 28
Attachment 2, Certificate of
Currency Checklist, pg 29
Attachment 3, Submission of
Information, pg 30
• Deleted “Completion of a Clinical Trails Advice Form
and submission to VMIA” as no longer relevant
• Inserted new paragraph “As these Guidelines are
broader than ….(PICF)”.
• Deleted row “Clinical Trails Advice Form” as no
longer required.
• Amended last row to read “VMIA clients should use
the Victorian Department of Health …”
• Replaced section titled “Reviewed by a Human
Research Ethics Committee (HREC)
• Amended second paragraph from “A VMIA client
must sign a …” to Public Hospital’s must sign a …”
• Amended last section, 3 rd bullet to “The clinical trial
addresses relevant clinical questions”.
• Deleted 5 th bullet point regarding Intellectual
Property ownership
• Amended introductory paragraphs
• Amended requirements 1 & 4
• Additional Guidance is provided below checklist.
• Amending contact details for previously agreed
Schedule &/ Schedule 4’s.
• Clarified information regarding SUSAR notification
• Deleted entire page as CTAF is no longer relevant.
• Deleted last row regarding CTAF submission as no
longer required.
• Deleted CTAF as no longer required.
• Amended introductory paragraphs
• Amended requirements 1 & 4
• Additional Guidance is provided below checklist
• Deleted first row re submission of CTAF
• Deleted 3 rd table re Department of Health
contact details

Contents
Introduction 1
Application of the Guidelines 2
Quick Reference Guide 3
Clinical Trials Governance 4
Clinical Trials Sponsorship 6
The VMIA Minimum Insurance Requirements for Commercially Sponsored Clinical Trials 8
The VMIA Indemnity Requirements for Clinical Trials 10
Clinical Trial Agreements 13
Guidelines for Amendments to Standard Clinical Trial Agreements: Schedule 7 / Schedule 4 17
Participant Information and Consent Form (PICF) 20
Disclosure Obligations 21
Risk Management for Organisations Conducting Clinical Trials 22
Key Elements of the Risk Management Process 23
Key References 24
Attachment 1: Certificate of Currency Checklist 27
Attachment 2: Submission of Information 28
© 2012 VMIA.
The information provided in this document is intended for general use only. VMIA does not warrant the
information in this document and does not accept any liability to any person for information or advice
or the use of such information or advice provided in this document. VMIA encourages the free transfer,
copying and printing of this document if such activities support the purpose and intent for which
this document was developed. This document is protected by and its use subject to the terms and
conditions of VMIA’s Copyright Licence.

Introduction
Clinical trials play a very important role in the Australian health sector, providing significant benefits to
both the Australian community and the economy.
Australia is a leader in the governance of clinical trials. This is a key factor in Australia’s competitiveness
as a clinical trial host country. The speed and the efficiency by which proposed clinical trials are
considered and approved is also a key factor.
Victorian Managed Insurance Authority (VMIA) fully supports Victoria’s efforts to maintain the highest
standards of clinical trial and research governance, and efficient approval processes for clinical trials.
The clinical trial guidelines (Guidelines) assist in this by providing information to public health services/
hospitals in Victoria (VMIA’s clients) regarding the insurance and risk management of clinical trials
conducted under the Therapeutic Goods Administration (TGA) notification (CTN) and exemption
(CTX) schemes and links to key information provided by regulatory and industry bodies. VMIA clients
conducting other clinical trials which do not require TGA notification or approval may also find these
Guidelines useful. In the case of these other trials, if a VMIA client has any questions regarding
insurance cover, they should contact their VMIA Contact Officer.
The Guidelines have been developed in consultation with the Victorian Department of Health to ensure
that they are consistent with the State Government’s policies, current multi-state agreements and the
overall governance framework for clinical trials in Victoria and Australia.
The Guidelines recognise that the risk of conducting a clinical trial must be effectively managed by the
VMIA’s clients involved. VMIA clients assume all or part (in commercially sponsored trials) of the risk and
must effectively manage this risk to minimise their exposure to both insurable and non-insurable losses.
Adherence to the VMIA’s Minimum Insurance Requirements, relevant government policies and agreed
standard documentation, plus use of these Guidelines, will assist the VMIA’s clients to minimise their
risks in the clinical trial area.
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Application of the Guidelines
These Guidelines apply, as appropriate, to any clinical trial conducted under the TGA Clinical Trial
Notification (CTN) Scheme, or the Clinical Trial Exemption (CTX) Scheme.
This includes the following categories of clinical trials:
• Commercially-sponsored clinical trials of medicines or devices. The commercial sponsor may be a
pharmaceutical or device company, or a contract research organisation.
• Clinical trials of medicines or devices which have no commercial sponsorship. This includes
investigator-initiated clinical trials and collaborative/cooperative research group clinical trials.
There are mandatory requirements with respect to the following:
• Compliance with the VMIA’s Minimum Insurance Requirements
• Notification of all Suspected Unexpected Serious Adverse Reactions to VMIA
The Guidelines should be read in conjunction with:
• ‘The Australian Clinical Trial Handbook’ TGA, 2006
• ‘Access to unapproved therapeutic goods – Clinical Trials in Australia’ TGA, 2004
• Relevant policies, guidelines and standard operating procedures published by the Consultative
Council for Human Research Ethics (CCHRE), Victorian Department of Health
The Guidelines will be updated periodically. As these guidelines are broader than Insurance and Risk
Management VMIA will consult with the Victorian Department of Health and relevant stakeholders to
receive specific guidance on the following sections:
• Clinical Trials Governance
• Clinical Trials Sponsorship
• Clinical Trials Agreements
• Guidelines for Amendments to Standard Clinical Trial Agreements: Schedule 7 /
Schedule 4
• Participant Information and Consent Form (PICF)
VMIA clients should refer to the current copy of the Guidelines on the VMIA’s website at
www.vmia.vic.gov.au
2 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Quick Reference Guide
Key Points
Approval from VMIA
Insurance Requirements
HREC
SUSAR Reports
Serious Adverse Events
National and Victorian
Standards & Policies
Standard Agreements
& Forms
Amendments to the
approved Clinical Trial
Research Agreements
Participant Information &
Consent Forms
Description
There is no requirement to seek approval from VMIA for any
aspect of a clinical trial
It is mandatory to comply with the VMIA’s Minimum Insurance
Requirements and provide a copy of the commercial sponsors
Certificate of Currency to:
Email: clinicaltrials@vmia.vic.gov.au
VMIA clients must ensure any proposed clinical trial is ethically
and scientifically reviewed. Prior to its commencement, each trial
must have been approved by the relevant HREC
It is mandatory to provide VMIA with a copy of all Suspected
Unexpected Serious Adverse Reaction (SUSAR) reports relating
to a clinical trial at a Victorian site to:
Email: susar@vmia.vic.gov.au
It is no longer necessary for the VMIA’s clients to provide
notification of all Serious Adverse Events. Only events classified
as SUSAR are mandatory notifications
Any aspects of a clinical trial that are not consistent with
the National and Victorian standards and policies should be
discussed with the Victorian Department of Health
There are a range of approved standard agreements and forms
available for clinical trials
If the VMIA’s clients elect not to use the standard Agreements
and Forms, legal advice should be obtained
Any proposed changes to approved standard Clinical Trial
Research Agreements require the commercial sponsor
(Schedule 7) or research body (Schedule 4) to submit proposed
amendments to VMIA via email:
Email: clinicaltrials@vmia.vic.gov.au
VMIA will forward the proposed amendments to the Southern
and Eastern Border States (SEBS) Committee for review
VMIA clients should use the Victorian Department of Health
recommended Participant Information & Consent Form as
developed by the National Health and Research Council
(NHMRC) to standardise ethics review processes nationally
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Clinical Trials Governance
Review by a Human Research Ethics Committee (HREC)
Prior to the commencement of any proposed clinical trial, VMIA clients must ensure that the clinical trial
has been ethically and scientifically reviewed by a HREC in accordance with the principles set out in the
NHMRC’s National Statement on Ethical Conduct in Human Research (2009) (National Statement).
Ethical Review of Multi-site Clinical Trials
Victoria participates in programs that are intended to expedite the ethical review process for multi-site
studies. This section provides a brief outline of the current programs.
Streamlined system for ethical and scientific review of multi-site
research in Victoria (in place)
The streamlined system for ethical and scientific review of multi-site research has been developed
by the Victorian Department of Health, under the governance of the (Victorian) Consultative Council
for Human Research Ethics (CCHRE). It applies to research occurring at multiple sites by different
organisations within Victoria.
The streamlined system applies to interventional research involving a drug/device trial, radiation
therapy, surgery, treatment or diagnostic procedure and studies associated with ongoing activities
relating to trials that have been conducted. This may include observational research and evaluation of
a trial, developing a registry and other post-marketing surveillance activities.
The system applies to research involving interventional clinical trials, including drug and device trials that
are investigator initiated, commercially sponsored trials, or trials conducted by collaborative groups.
The CCHRE has, to date, accredited eight HRECs within public hospitals to undertake single
ethical review of multi-site clinical trials. Participating public hospital organisations have signed a
memorandum of understanding with the CCHRE.
Under this system, a participating VMIA client agrees to:
• Accept the ethical and scientific review of a reviewing HREC and not undertake any further review
by its own HREC
• Undertake a process of site-specific assessment as part of its research governance responsibilities
• Not begin a clinical trial at a site unless it has received ethical approval from a reviewing HREC and a
site-specific assessment authorisation to conduct the trial at the relevant site. The Chief Executive or
delegate must authorise the site specific assessment for the clinical trial to be conducted at the site
• Ensure compliance with HREC review standards and processes.
VMIA clients that participate in the streamlined system must comply with these requirements.
4 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Clinical Trials Governance
Interstate Mutual Acceptance – for multi-centre clinical trials (in place)
The Victorian Department of Health, Queensland Health and the NSW Ministry of Health have
established a process of mutual acceptance of ethical and scientific review in public hospitals by
NHMRC-certified HRECs that are also accredited with the CCHRE, regarding multicentre, clinical
trials being conducted in more than one of these States.
VMIA clients that participate in the Interstate Mutual Acceptance for multi-centre clinical trials system
should comply with these requirements.
National Approach to Single Ethical Review of Multi-Centre
Research (proposed)
The National Approach is being developed for the publically-funded health sector and is designed to
recognise a single scientific and ethical review process within and across all Australian jurisdictions.
Participating jurisdictions would recognise a review made by a nominated NHMRC certified
institution’s HREC in a jurisdiction. More information will become available on the CCHRE website
following implementation.
The NHMRC has developed a range of tools to support the National Approach, including the National
Certification Scheme for institutions and their HRECs. Details of tools and guidance material regarding
the National Approach, can be found at the NHMRC’s Human Research Ethics Portal.
As at the date of publication of these Guidelines, the Victorian Department of Health had not yet
commenced any processes for Victorian sites that would allow them to accept a single ethical review
of multi-centre human research under the National Approach.
Approval of Clinical Trials
The VMIA’s client at which the trial will be conducted, referred to as the ‘Approving Authority’, gives the
final approval for the conduct of the trial at the site, having due regard to advice from the HREC.
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Clinical Trials Sponsorship
The sponsor of a clinical trial is the company, institution or organisation, body or individual that takes
overall responsibility for the clinical trial.
Table 1 is a summary of the sponsorship, recommended agreement, indemnity and insurance
arrangements for commercial trials and research studies. See the relevant sections of the Guidelines
for more detail on each area.
Table 1
Type of
Sponsorship
Recommended
Agreement
Indemnity
Arrangement
Insurance
Arrangement
Commercial Trials
Commercially
Sponsored
Trial of a
Pharmaceutical
Clinical Trial Research
Agreement –
Standard Form
Available via Medicines
Australia website
Schedule 3 to Agreement
Use standard indemnity
form on Medicines
Australia website
Schedule 4 to Agreement
See the VMIA’s Minimum
Insurance Requirements
Commercially
Sponsored Trial
of a Device
Clinical Investigation
Research Agreement –
Standard Form
Available via Medical
Technology Association
of Australia website
Schedule 3 to Agreement
Use standard indemnity
form for a Clinical
Investigation on Medical
Technology Association of
Australia website
Schedule 4 to Agreement
See the VMIA’s Minimum
Insurance Requirements
Contract
Research
Organisation
(CRO) – acting
as the local
sponsor
Clinical Trial Research
Agreement – CRO specific
Available via Medicines
Australia website
Schedule 3 to Agreement
Use standard indemnity
form on Medicines
Australia website
Schedule 4 to Agreement
See the VMIA’s Minimum
Insurance Requirements
Research Studies
Collaborative
or Cooperative
Research Group
(CRG)
Investigator
Initiated Study
(IIS)
Clinical Trial Research
Agreement – CRG specific
Available via Medicines
Australia website
Clinical Trial Research
Agreement – IIS specific
A guideline agreement
is available on the VMIA
website
Both the CRG and IIS standard agreements have the same
general ‘liability and insurance’ clause.
The intent of the clause is that each party is liable for its
acts and omissions in relation to the conduct of the study.
VMIA clients, including its employees, participating
in an approved research study are covered by the
VMIA’s insurance program subject to any relevant
exclusions, terms and/or conditions.
Principal Investigators who are a party named within a
current employment contract with the VMIA client are also
covered by the VMIA’s Insurance Program, subject to any
relevant exclusions, terms and/or conditions.
The sponsor is required to maintain insurances to meet any
legal liability obligations.
Guidance on how the types of sponsorships are categorised is provided in Table 2.
6 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Clinical Trials Sponsorship
Table 2
Types of Sponsorship
Commercially Sponsored Clinical Trials
• It is initiated by a pharmaceutical/device company or other commercial entity and not by an
investigator at an insured Victorian public health service.
• The pharmaceutical/device/biotechnology company (or an Australian based contract research
organisation engaged by the pharmaceutical/device company), is the sponsor for the purposes of
the CTN/CTX Scheme.
• The clinical trial is conducted to investigate a drug/device/biological for commercial exploitation
by its manufacturer/sponsor.
• The protocol has been developed and is the responsibility of a pharmaceutical/device company or
other commercial entity.
• Intellectual property developed as a result of the clinical trial is owned by the relevant
pharmaceutical/device company.
Research – Collaborative/Cooperative Research Group Clinical Trials
• It is initiated by a CRG.
• The CRG is the primary author and custodian of the clinical trial protocol.
• The research addresses relevant clinical questions and not pharmaceutical/device industry or
commercial needs.
• The CRG has declared the nature of any sponsorship from a pharmaceutical entity or any other
entity that may directly benefit commercially from the research outcomes.
• Principal Investigators who are a party named within a current employment contract with the
VMIA client are also covered by the VMIA’s Insurance Program, subject to any relevant exclusions,
terms and/or conditions.
Research – Investigator Initiated Study Clinical Trials
• The sponsor for the purposes of the CTN/CTX Scheme application and the overall conduct of the
study is usually the hospital/institution at which the trial will be conducted.
• A commercial pharmaceutical/device company is not sponsoring the conduct of the study,
although it may contribute funds or the study drug(s)/device.
• The clinical trial addresses relevant clinical questions.
• The Principal Investigator or the Hospital/Institution is the primary author and custodian of the
clinical trial protocol.
• Principal investigators who are a party named within a current employment contract with the
VMIA client are also covered by the VMIA’s Insurance Program, subject to any relevant exclusions,
terms and/or conditions.
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The VMIA’s Minimum Insurance Requirements
for Commercially Sponsored Clinical Trials
A commercial sponsor must ensure it has appropriate and adequate insurance with respect to its
responsibilities for a clinical trial and its indemnity obligations. The commercial sponsor must maintain
insurance that meets VMIA’s minimum insurance requirements for the entire period of the commercially
sponsored clinical trial. The commercial sponsor must provide evidence of current insurance upon request.
A commercial sponsor must provide to the VMIA Client a certificate of currency in a form that is
acceptable to the VMIA, see Table 3 below.
VMIA Minimum Insurance Requirements for Commercially Sponsored Clinical Trials
The Certificate of
Currency must:
1. Detail the type of insurance – Public and Product Liability – or equivalent such as
General Liability or Clinical Trials Insurance.
2. Include as a named insured the full, legal name of the Australian entity acting as
a sponsor.
3. Be through an insurer either approved by the Australian Prudential Regulation
Authority, or a foreign insurer. All insurers are required to hold Standard & Poor’s
financial rating of not less than ‘A-’.
If the relevant insurer has a financial rating of less than ‘A-’, or specific assistance is
required to determine the financial rating, please contact a VMIA Contact Officer via
email clinicaltrials@vmia.vic.gov.au
4. Detail the period of insurance.
5. Provide insurance coverage for a minimum of A$10 million for any one
occurrence and in the annual aggregate.
6. Not contain an excess/deductible, or self insured retention amount greater
than A$25,000 for each and every claim or series of claims arising out of one
original cause.
When and what to submit – commercial sponsor’s certificate of currency
Pre-approval of the clinical trial
During the HREC approval process for new commercially sponsored clinical trials, VMIA Clients should
complete the following:
1. review the commercial sponsor’s Certificate of Currency (CoC) provided by the sponsor against the VMIA
Minimum Insurance Requirements
2. submit the CoC to VMIA via email clinicaltrials@vmia.vic.gov.au if
a. there is any non-compliance with the VMIA Minimum Insurance Requirements or
b. assistance is required to obtain the financial rating of the commercial sponsor’s insurer with respect
to requirement number 3.
Approved clinical trials
When a commercially sponsored clinical trial has received Site Specific Authorisation (SSA), VMIA Clients should:
1. submit to VMIA via email clinicaltrials@vmia.vic.gov.au a copy of the:
a. SSA approval certificate (providing details of the name and the duration of the clinical trial); and
b. commercial sponsor’s CoC for the relevant trial, even if it has been previously submitted during the
pre-approval process.
8 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

The VMIA’s Minimum Insurance Requirements
for Commercially Sponsored Clinical Trials
Non-compliance with the VMIA’s Minimum Insurance
Requirements for Commercially Sponsored Clinical Trials
In most instances, where there may be non-compliance with VMIA’s Minimum Insurance Requirements,
an additional request to provide the mandatory information on a Certificate of Currency is usually
sufficient to clarify compliance. If unsure please contact VMIA Contact Officer for assistance via email
to clinicaltrials@vmia.vic.gov.au
In the event a commercial sponsor of a clinical trial is unable or unwilling to meet the VMIA’s Minimum
Insurance Requirements, the VMIA’s client is encouraged to negotiate as far as possible to obtain
insurance arrangements that meet the VMIA’s Minimum Insurance Requirements. Where the VMIA’s
client is unable to negotiate appropriate insurance, written advice should be provided to VMIA for
consideration via email to clinicaltrials@vmia.vic.gov.au. The written advice should be provided prior to
signing the Clinical Trial agreement. It should include the following:
• Reasons why the VMIA’s Minimum Insurance Requirements could not be negotiated and
written justifications for recommendations of non-compliance with the VMIA’s Minimum
Insurance Requirements.
• Evidence of a risk assessment undertaken to support any recommendations for non-compliance,
including a clear articulation of the benefits versus associated risk.
• A nominated contact person of the commercial sponsor to allow VMIA to liaise directly with the
commercial sponsor for additional information/clarification (if required).
VMIA:
• Will consider all requests in accordance with its internal governance procedures.
• Will review the financial strength of the insurer and/or commercial sponsor and will also evaluate the
benefit of the clinical trial versus the risk associated with non-compliance.
• Will advise in writing if it accepts non-compliance with VMIA’s Minimum Insurance Requirements.
• Retains the sole discretion to maintain its mandatory Minimum Insurance Requirements.
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The VMIA’s Indemnity Requirements
for Clinical Trials
Risk and liability for commercial and research study sponsors
To manage the risk associated with legal liability that may arise from the approval or the conduct of a
clinical trial, relationships between sponsors, investigators, institutions and/or organisations should be
well defined by legal and financial agreements. An important part of those agreements is the indemnity
to cover the potential liability of each party involved and the insurance requirements.
It is prudent for VMIA clients to avoid assuming any liability which they would not otherwise be
responsible for. If any liability in addition to that in the standard agreement is assumed by the VMIA’s
client, it might prejudice their insurance cover.
Indemnity arrangements for conduct of a research study clinical trial
Research studies standard agreements include a general liability and insurance clause.
VMIA clients are covered by the VMIA’s Insurance Program. A Principal Investigator who is a party
named within a current employment contract with the VMIA client is also covered by the VMIA’s
Insurance Program, subject to any relevant exclusions, terms and/or conditions.
Indemnity arrangements for conduct of a commercially sponsored
clinical trial
The VMIA’s clients must ensure that adequate arrangements are in place to indemnify the parties for
the conduct of the trial at the trial site(s). There are standard agreements and indemnity forms for
commercially sponsored trials.
The commercial sponsor must be an Australian entity. Therefore, in all cases, the indemnity must be
provided by an Australian corporate entity. One of the reasons the commercial sponsor must be an
Australian entity, is that it is comparatively easier to enforce the indemnity against an Australian-based
entity with assets in Australia, than against an overseas-based entity.
If an overseas entity with no presence or assets in Australia provides the indemnity, and it becomes
necessary to enforce the indemnity against that entity, it is likely that enforcement proceedings would
have to be instituted, at significantly greater cost and inconvenience in a foreign jurisdiction.
A pharmaceutical or device company may engage the services of a contract research organisation (CRO)
to act as sponsor of a clinical trial and to perform all the other functions of a sponsor. In such cases, the
CRO is the commercial sponsor and must provide the appropriate indemnity in favour of the VMIA’s client.
Where a clinical trial is to be conducted by a VMIA client at a site under its control, the commercial
sponsor must provide an indemnity in favour of the VMIA’s client.
VMIA recommends the following standard form of indemnities:
• Pharmaceutical trial
Medicines Australia Form of Indemnity for Clinical Trials: Standard
• Device trial
Medical Technology Association of Australia Form of Indemnity for a Clinical Investigation
10 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

The VMIA’s Indemnity Requirements for Clinical Trials
Indemnity arrangements for HREC review only of the clinical trial
There is no standard HREC Review only template for research study clinical trials.
In a commercially sponsored trial, where a HREC of a VMIA client undertakes a review of a clinical
trial, the commercial sponsor must provide an indemnity in favour of the VMIA’s client.
VMIA recommends the following standard form of indemnities:
• Pharmaceutical trial
Medicines Australia Form of Indemnity for Clinical Trials: HREC Review Only
• Device trial
Medical Technology Association of Australia Form of Indemnity for a Clinical Investigation –
HREC Review Only.
Parties to the indemnity in a commercially sponsored clinical trial
It is recommended that standard indemnity forms are used. The VMIA’s client should be named as ‘the
Indemnified Party’ and the commercial sponsor as ‘the Sponsor’.
It is unnecessary to name the VMIA’s client’s HREC in the section that describes ‘the Indemnified
Party’ on an indemnity provided by a commercial sponsor to a VMIA client. Clause 3 of each of the
standard indemnity forms states that ‘the Sponsor’ indemnifies members of, and advisors to, ‘the
Indemnified Party’s’ HREC.
A party other than the VMIA’s client at which the clinical trial is to be conducted, may seek to be
indemnified by the commercial sponsor of a clinical trial. In such cases, a separate form of indemnity
should be used for each party that is indemnified by the commercial sponsor. The definition of ‘the
Indemnified Party’ in the indemnity form given in favour of the VMIA’s client should not name any party
other than the relevant VMIA Client.
A commercial sponsor must provide the indemnity in its own right and not as an agent of another
entity. VMIA clients should ensure that any indemnity provided by a commercial sponsor does not
contain any wording which indicates that the commercial sponsor is providing the indemnity as an
agent of another party, or any wording which suggests the existence of an agency arrangement.
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The VMIA’s Minimum Requirements for Clinical Trials
Non-standard indemnity arrangements
If a sponsor wishes to amend the standard indemnity form or clause, it is recommended that the
VMIA’s client submits the proposed non-standard indemnity form or clause to VMIA Contact Officer for
review via email clinicaltrials@vmia.gov.au
VMIA will consider whether there are any insurance issues with the proposed non-standard indemnity.
VMIA may recommend that legal advice is sought for non-insurance related issues. The VMIA’s client
should negotiate the payment of legal fees with the commercial sponsor.
External Expert Reviewer Professional Indemnity for First Time in
Human Trials (FTIH)
If the external expert reviewer is an employee of a VMIA client
The expert reviewer is covered by the VMIA’s Insurance Program, subject to any relevant exclusions,
terms and/or conditions.
If the external expert reviewer is not an employee of a VMIA client
VMIA clients should ensure that the expert reviewer provides a Certificate of Currency of a
Professional Indemnity (PI) policy covering the reviewer for the provision of these services to the
VMIA’s client.
In the event that the expert reviewer does not have a current PI policy or cannot provide confirmation
that their PI policy covers them for the subject review, or their employer will not cover them, the VMIA’s
client should discuss this matter with their VMIA Contact Officer via email clinicaltrials@vmia.gov.au
The FTIH Protocol is also accessible on the VMIA website at www.vmia.vic.gov.au
12 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Clinical Trial Agreements
VMIA recommends using the standard Clinical Trial Research Agreements (CTRA) and the standard
Clinical Investigation Research Agreement (CIRA) (device trials).
The use of a CTRA is an effective way for parties involved in the conduct of a clinical trial to define and
allocate their respective roles and responsibilities. Most parties involved in the conduct of clinical trials
in Victoria are familiar with these CTRAs. Their use is also likely to significantly reduce the time and
cost spent negotiating the terms of an agreement for a clinical trial.
The CTRAs contain common, standard provisions, that are sufficiently flexible to accommodate
individual local sponsors and international organisation operational requirements. The use of the
CTRAs should, in most cases, remove the need for VMIA clients to obtain extensive legal advice.
The standard agreements contain provisions that address most of the typical issues that are relevant
to the arrangements for the conduct of a clinical trial in Victoria. Each CTRA/CIRA also reflects
specific requirements which are relevant to the arrangements for the type of clinical trial to which
it relates. For example, the CTRA – Commercially Sponsored Trials incorporates the indemnity
and insurance requirements for commercially-sponsored clinical trials, and the Clinical Investigation
Research Agreement (for device studies) incorporates references to the standards that are relevant for
device studies.
The CTRA/CIRA, through Schedule 7 of the agreement, can include amendments by agreement
between the parties to reflect any specific requirements or issues regarding any particular clinical trial.
The information in Table 4 below has been provided to assist VMIA’s clients in selecting and using the
appropriate standard CTRA/CIRA for a particular clinical trial.
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Clinical Trial Agreements
Table 4
Type of Trial/Study
Commercially-
Sponsored Trials of
a Pharmaceutical
Description and relevant agreement
The standard Clinical Trial Research Agreement (CTRA) should be used for a
Commercially-Sponsored clinical trial of a pharmaceutical.
The parties to the agreement are:
• The ‘Institution’, which is the relevant VMIA client.
• The ‘Sponsor’, which is the commercial sponsor of the clinical trial. The ‘Sponsor’
must be an Australian entity because, among other reasons, the ‘Sponsor’ is the
sponsor for the purpose of the CTN Scheme and the ‘Sponsor’ must provide an
indemnity (in the appropriate form) in favour of the VMIA’s client. These are
obligations that must be performed by an Australian entity.
• The ‘Principal Investigator’, though named in Schedule 1 to the Agreement, is not
a party to the CTRA. However, the Principal Investigator may sign the Agreement
to acknowledge the obligations it imposes.
The CTRA – Commercially-Sponsored Trials may be amended by inserting ‘Special
Conditions’ into Schedule 7 of the Agreement. When the CTRA was drafted, it was
envisaged that Schedule 7 amendments would be limited to the unique operational
requirements of a party and that Schedule 7 would not be used to alter the
substantive provisions of the CTRA.
The commercial sponsor of the trial must provide evidence of compliance with
VMIA’s Minimum Insurance Requirements.
Commercially-
Sponsored Trials of
a Device
The Clinical Investigation Research Agreement (CIRA) should be used for a
commercially-sponsored clinical trial of a device.
The parties to the CIRA are as follows:
• The ‘Institution’, which is the relevant VMIA client.
• The ‘Sponsor’, which is the commercial sponsor of the clinical trial. The ‘Sponsor’
must be an Australian entity because, among other reasons, the ‘Sponsor’ is the
sponsor for the purpose of the CTN/CTX Scheme and the ‘Sponsor’ must
provide an indemnity (in the appropriate form) in favour of the VMIA’s client.
These are obligations that must be performed by an Australian entity.
• The ‘Principal Investigator’, though named in Schedule 1 to the CIRA, is not a
party to the CIRA. However, the Principal Investigator may sign the CIRA to
acknowledge the obligations it imposes.
The CIRA may be amended through Schedule 7 by inserting any agreed ‘Special
Conditions’. When the CIRA was drafted, it was envisaged that amendments would
be limited to the unique operational requirements of a party and that Schedule 7
would not be used to significantly alter the substantive provisions of the CIRA.
The commercial sponsor of the trial must provide evidence of compliance with
VMIA’s Minimum Insurance Requirements.
14 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Clinical Trial Agreements
Table 4 continued
Type of Trial/Study
Contract Research
Organisation (CRO)
acting as the Local
Sponsor
Description and relevant agreement
The CTRA – Contract Research Organisation acting as the Local Sponsor, should be
used for a commercially-sponsored clinical trial in which a CRO has been engaged
to act as sponsor of the trial.
The CRO will usually have been engaged by a commercial pharmaceutical or a
device company based overseas (or in Australia) to act as sponsor for the purposes
of the CTN/CTX application, and to assume all responsibilities and obligations that
attach to a local sponsor of a commercially sponsored clinical trial.
The parties to this CTRA are as follows:
• The ‘Institution’, which is the relevant VMIA client.
• The ‘Local Sponsor’, which is the CRO that has been engaged to act as sponsor.
The ‘Local Sponsor’ must be an Australian entity because, among other reasons,
the ‘Local Sponsor’ is the sponsor for the purpose of the CTN/CTX Scheme, and
the ‘Local Sponsor’ must provide an indemnity (in the appropriate form) in favour
of the VMIA’s client; these obligations must be performed by an Australian entity.
The ‘Principal Investigator’, though named in Schedule 1 to this CTRA, is not a
party to the CTRA/CIRA. However, the Principal Investigator may sign the CTRA to
acknowledge the obligations it imposes.
As the de facto commercial sponsor of the trial, the CRO must:
• Provide the appropriate form of indemnity in favour of the VMIA’s client.
• Provide evidence of compliance with the VMIA’s Minimum Insurance Requirements.
The CTRA – Contract Research Organisation acting as the Local Sponsor may be
amended through Schedule 7, by inserting ‘Special Conditions’. When this CTRA
was drafted, it was envisaged that amendments would be limited to the unique
operational requirements of a party, and that Schedule 7 would not be used to
significantly alter the substantive provisions of this CTRA.
Collaborative
or Cooperative
Research Group
(CRG) Studies
The CTRA – Collaborative or Cooperative Research Group (CRG) Studies should be
used when a collaborative/cooperative research group is the sponsor of the clinical trial.
The parties to this CTRA are as follows:
• The ‘Institution’, which is the relevant VMIA client.
• The ‘CRG’, which is the collaborative or cooperative research group that is the
sponsor of the clinical trial for the purpose of the CTN/CTX Scheme, and which is
responsible for initiating, managing, developing and coordinating the clinical trial.
• The ‘Principal Investigator’, though named in Schedule 1 to this CTRA, is not a
party to the CTRA. However, the Principal Investigator may sign the CTRA to
acknowledge the obligations it imposes.
There is no requirement under the CTRA – Collaborative or Cooperative Research
Group (CRG) Studies – for a CRG to provide an Indemnity or evidence of its
insurance arrangements. However, if a CRG incorporates such provision into the
CTRA, or otherwise offers such Indemnity, it would be prudent for a VMIA Client to
accept that indemnity.
This CTRA may be amended through Schedule 4 by inserting any agreed ‘Special
Conditions’. When this CTRA was drafted, it was envisaged that amendments would
be limited to the unique operational requirements of a party and that Schedule 4
would not be used to significantly alter the substantive provisions of this CTRA.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 15

Clinical Trial Agreements
Table 4 continued
Type of Trial/Study
For an Investigator
Initiated Study
Description and relevant agreement
There is no standard research agreement currently agreed between Medicines
Australia and the Victorian, NSW and QLD Health Departments. Until a standard
agreement becomes available for these studies, VMIA clients should seek their
own legal advice regarding an appropriate agreement.
A guideline agreement is available on the VMIA’s website www.vmia.vic.gov.au
Phase 4 Clinical Trial
(Medicines)
Non-Commercial
International
Sponsorship
Arrangements
There is no standard research agreement currently agreed between Medicines
Australia and the Victorian, NSW and QLD health departments. For these studies,
VMIA clients should seek their own legal advice regarding an appropriate agreement.
VMIA clients may also undertake clinical trials in collaboration with non-commercial
overseas or international partners such as universities, research institutes and
collaborative groups who do not have any representation in Australia. These trials
may be investigator initiated or collaborative group studies where each Australian
participating site acts as its own ‘sponsor’ for the purposes of the CTN notification
to the TGA.
VMIA clients will generally need to enter directly into a clinical trial agreement or
research collaboration agreement with the international partner. The agreements
will usually be on international templates which are not part of the suite of standard,
CTRA agreements recommended by VMIA.
VMIA clients should seek their own legal advice in respect of such international
agreements to ensure they do not contain clauses that are contrary to the VMIA’s
Minimum Insurance Requirements or clauses that impose additional indemnities on
parties to the agreement.
VMIA clients should consult with VMIA if they have any concerns about any such an
agreement, particularly in relation to any possible impact on the VMIA’s indemnity and
insurance cover or exposure of the client to potential insurance losses.
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Guidelines for amendments to Standard Clinical
Trial Agreements: Schedule 7 / Schedule 4
A sponsor may propose to amend these agreements to meet commercial or operational requirements,
or those of its’ international parent or an affiliate company.
Amendments to one of the standard clinical trial agreements are a matter between the parties to the
agreement. VMIA recommends that clients minimise amendments to the standard agreements. VMIA
does not have a role in approving or reviewing such amendments.
If a VMIA client is considering agreeing to an amendment which it considers may impact its insurance
cover. The VMIA client should contact a VMIA Contact Officer via email to clinicaltrials@vmia.vic.gov.au
The proposed amendments from the commercial sponsor may not be in the best interests of the
VMIA’s client, particularly if they:
• Seek to amend the standard indemnity arrangements
• Conflict in any way with the VMIA’s Minimum Insurance Requirements
• Involve an inappropriate transfer of risk to the VMIA’s client.
VMIA may recommend that legal advice is sought for non-insurance related issues. The VMIA’s client
should negotiate the payment of legal fees with the commercial sponsor.
Interstate harmonisation of proposed amendments via
Schedule 7 / Schedule 4
To support Australia’s competitiveness as a clinical trial destination, and to reduce the costs and
complexities for commercial sponsors in dealing with different institutions, the Victorian Department
of Health and some other interstate health departments have worked to provide agreed common
responses to proposed Schedule 7 amendments from commercial sponsors and Schedule 4
amendments from research bodies, for the same trial at institutions in these different states.
Given the previous work done by Victorian Department of Health, Queensland Health and
NSW Ministry of Health to harmonise agreed Schedule 7 / Schedule 4 amendments, a number
of in-principle positions have been agreed.
The advice from the Department of Health is as follows:
Drafting issues
• Clauses that merely restate the existing provisions of the Standard CTRA were not agreed for
inclusion. While it is understood that companies have been using such clauses for many years, it was
not the purpose of Schedule 7 / Schedule 4 clauses to allow for a re-drafting exercise in respect of
the clauses in the Standard CTRAs.
Clauses that seek to override the applicability of the Standard CTRA
• The purpose of the Standard CTRA is that there is certainty of application and uniformity across trials.
Any clauses that seek to make other documents (such as the trial protocol) override the Standard
CTRA are contrary to that intention, and therefore could not be included in Schedule 7 / Schedule 4.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 17

Guidelines for amendments to Standard Clinical
Trial Agreements: Schedule 7 / Schedule 4
Clauses contrary to Government insurance arrangements
• Victorian public hospitals, research facilities and institutes have standard insurance and indemnity
arrangements that apply to the whole of the Government sector. In Victoria, all public health
institutions are insured through the VMIA.
Clauses requiring the Institution to have certain types of insurance
• This cannot be accommodated, as the standard VMIA insurance and indemnity arrangements will
apply in any event.
Clauses seeking to impose additional indemnities on parties
• Victoria has adopted the Medicines Australia indemnity position set out in the Standard Medicines
Australia indemnities. As this position has long been accepted as the appropriate standard by both
Government and industry, clauses that seek to alter or re-state this indemnity position have not
been included.
Clauses clearly contrary to the provisions of the Standard CTRA
• The purpose of negotiating special conditions to be included in Schedule 7 / Schedule 4 is to
accommodate, as far as possible, project-specific clauses that clarified or added to the Standard
CTRA. The purpose was not to delete essential clauses, or to modify essential clauses that have been
the subject of long negotiation with Medicines Australia and, through them, the pharmaceutical
industry. The Standard CTRA reflects a fair and reasonable commercial agreement between the
contracting parties. Accordingly, clauses that seek to substantially alter the core provisions of the
agreement cannot be included in Schedule 7 / Schedule 4. This includes clauses that seek to alter
the substance of the publication provisions, the confidentiality provisions, the intellectual property
provisions, and the termination provisions.
Process for review of proposed Schedule 7 / Schedule 4 amendments
All proposed amendments for Schedule 7 and Schedule 4 must be referred to the Southern and
Eastern Border States (SEBS) Committee for review and advice. VMIA will forward any request for
amendments to the SEBS Committee, who will contact you with their advice. The requests must be in
the prescribed form available on the Queensland Health website, refer to page 27 for link. The request
should be emailed to VMIA via clinicaltrials@vmia.vic.gov.au.
The SEBS Committee may seek independent legal advice on the proposed amendment. This legal
advice will be for the benefit of participating States’ Health Departments.
The legal fees for the provision of this advice will be payable by the commercial sponsor. If there are
any trial site-specific amendments to these clauses, negotiations are to be conducted with the relevant
Institution and any further legal fees will be payable by the commercial sponsor.
18 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Guidelines for amendments to Standard Clinical
Trial Agreements: Schedule 7 / Schedule 4
It is the final decision of the commercial sponsor and the VMIA’s client, as parties to the clinical
trial agreement, to decide whether to accept the advice on a proposed Schedule 7 / Schedule 4
amendment provided by the Multi-State Committee as a result of this consultative process.
The terms of current agreements will not be varied, altered or affected in any way by the adoption of
Schedule 7/Schedule 4 clauses in future agreements.
The effect of having a clause endorsed for use in Schedule 7/Schedule 4 is as follows:
• All Victorian public hospitals, research facilities and institutes engaging in clinical trial-related
activities, will be advised that any agreement submitted which consists solely of the Standard CTRA
and previously agreed Schedule 7 / Schedule 4 clauses, may be accepted without further legal review.
• Legal review will be required if further clauses or changes are sought to be included in Schedule 7 /
Schedule 4, or there are other amendments to the Standard CTRA, or a non-standard agreement is
used. The costs associated with any legal review are to be met by the sponsor.
The details of any agreed Schedule 7 / Schedule 4 clauses for each sponsor will be made available to
all Victorian public health institutions on a confidential basis. Sponsors and prospective sponsors will
not be able to access information regarding clauses submitted by other sponsors, as this information is
regarded as commercial in confidence.
Previously agreed Schedule 7 / Schedule 4 amendments
VMIA clients can obtain a schedule of previously agreed Schedule 7 / Schedule 4 clauses with
specific commercial sponsors from the Victorian Department of Health.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 19

Participant Information & Consent Form (PICF)
Guidance
When setting out the possible risks of participation, please categorise the risks into those which are
serious versus those which are less serious, and those which are common versus those which are rare,
to assist participants to properly understand the risks they face in participating in the trial.
Please ensure the PICF explains clearly and fully how the privacy and confidentiality of the
participant’s data will be maintained. The PICF should state how data will be stored and disposed of,
including whether they will be stored in an identified, identifiable or not-identifiable state, where they
will be kept, who will have access to them, how long they will be stored, and what will happen to them
at the end of the storage period.
Tissue samples
If tissue samples are to be collected and stored, please set out how the participant’s confidentiality and
privacy will be maintained by specifying whether tissue samples (and, if appropriate, the code linking
the samples to the participant’s identity), will be stored in an identified, identifiable or de-identified
state. Other considerations include: where they will be kept, who will have access to them, how long
they will be stored for and how they will be destroyed at the end of the trial.
Radiation
If the study involves exposure to radiation, which is in addition to the standard treatment and required
specifically as part of the research, participants must be clearly informed. The PICF should quantify the
level of exposure to radiation which participation in the study will involve, for example, by comparison to
the level of background radiation an average person is exposed to in the course of a year.
Pregnancy
If the hospital or sponsor is interested in obtaining pregnancy data if the partner of a participant
becomes pregnant, a separate Pregnant Partner Information and Consent Form must be prepared to
obtain her consent for collecting this information. It must contain the same information in relation to
privacy and confidentiality of that data as is set out above.
Please ensure in every case that consideration is given to whether the pregnancy warning should be
given in the PICF. As a general rule, almost every drug trial will require a pregnancy warning, and a
number of device trials will require the warning. This warning will usually include a warning about a
participant being or becoming pregnant, breastfeeding or fathering a child whilst participating in the
study and for a period of time after the study ends, as well as the use of appropriate contraception.
20 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Disclosure Obligations
VMIA’s Notification Obligations
Previously VMIA clients were required to notify the VMIA of all Serious Adverse Events (SAE’s.)
VMIA clients may still have reporting obligations under a particular clinical trial agreement to promptly notify
the sponsor of the occurrence of any SAE, pursuant to the terms of an indemnity and/or agreement.
However, the VMIA has sought to reduce the administrative burden by only requiring its clients to
notify of any ‘Suspected Unexpected Serious Adverse Reaction’ (SUSAR).
Types of events which do not usually require SUSAR notification
• General deterioration in a patient’s condition
• Minor events that have resolved
• Known adverse events/side effects
• Clearly identified unrelated events
• International events
What must be submitted to the VMIA?
• The same SUSAR form that is completed for the responsible HREC of the clinical trial.
• The VMIA does not require any additional patient specific details (such as patient name or date of birth).
However, an ability to identify the patient is required in the event that a claim arises, and if possible,
an identifier such as the trial participants ID should be included.
• VMIA clients are only required to report SUSAR’s in respect of their own participants.
How must the VMIA be notified?
The SUSAR form must be submitted to the VMIA via email to susar@vmia.vic.gov.au.
The RiskMan system is also able to receive SUSAR notifications electronically.
When must the VMIA be notified?
VMIA clients must submit a copy of the SUSAR form to the VMIA at the same time that it is submitted
to the responsible HREC for the clinical trial.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 21

Risk Management for Organisations
Conducting Clinical Trials
Effective risk management is an integral and essential part of ensuring patient safety in clinical trials.
Risk management supports decision makers in understanding the benefits of conducting a clinical trial
versus the risk and/or hazards associated with patient safety.
VMIA does not prescribe how to undertake a risk assessment for a clinical trial.
VMIA clients are required to maintain a risk management framework that aligns with the principles and
practices of the Australian/New Zealand Risk Management Standard (AS/NZSIS0 31000:2009),
the Victorian Government Risk Management Framework and existing legislation such as the Financial
Management Act 1994 and the Victorian Managed Insurance Authority Act 1996. Risk management
should also be consistent with requirements of the relevant legislation, regulations and guidelines
under which clinical trials are conducted.
Before entering into a clinical trial VMIA clients need to ensure an appropriate methodology and
approach is in place to identify, assess and appropriately manage all risks associated with undertaking
the proposed clinical trial. This should include understanding the key causal and contributory factors
that may lead to a preventable adverse event. Having quality tools, guidelines and process to support
enhanced risk outcomes is essential. A fundamental element of effective risk management is ensuring
there are well designed controls for key risks that are regularly tested and monitored.
To support good governance there should be a prescribed, documented reporting process and
escalation process in place, particularly for all risks outside the entity’s agreed acceptable tolerance
limits. All risk assessments should be recorded and documented in accordance with the entity’s own
internal document management requirements.
22 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Key Elements of the Risk
Management Process
Establish the Context
Understand the external, internal and
context in which clinical trials risk process
will take place. Ensure there is appropriate
criteria to assess the risks.
Communicate
& Consult
Communicate and
consult with all
relevant stakeholders
at each stage of the
risk management
process.
Identify Risks
Identify where, when, why and how a
risk could impact patient safety, the
objective of the clinical trial and the
organisation’s objectives.
Analyse Risks
Identify and evaluate existing controls
for identified risks. Assess the
consequences and likelihood and
determine the risk rating.
Evaluate Risks
Compare estimated risk rating against the
criteria and consider the balance between
potential benefits and adverse outcomes.
Based on the risk rating determine if any
treatments are required to reduce either the
consequence or likelihood of the risk.
Monitor &
Review
Monitor & review the
risk management
process and
ensure there is an
appropriate risk
reporting structure
in place. Risks and
the effectiveness
of controls and risk
treatments need
to be regularly
monitored as risks
are dynamic
not static.
Treat Risks
Not all risks require additional treatment if
the current risk is tolerable and the current
controls are highly effective. If a risk requires
additional controls or treatment develop and
implement specific cost-effect plan. Review
additional controls to rate their effectiveness
after a reasonable period.
Adapted from the Australian/New Zealand Risk Management Standard.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 23

Key References
Policies and Guidelines
Document Entity Link
National
National Statement
on Ethical Conduct in
Human Research 2009
Australian Code for the
Responsible Conduct
of Research 2007
Note for Guidance on
Good Clinical Practice
The Australian Clinical
Trial Handbook 2006
Access to Unapproved
Therapeutic Goods
– Clinical Trials in
Australia 2004
Victoria
Streamlined Ethical
Review of Multi-Site
Clinical Trials
Standard Operating
Procedures for
Victoria’s Central Ethics
Review System for
Multi-Site Clinical Trials
Ethics Checklist for
Coordinating Principal
Investigators
How to make a HREC
application
HREC Application
Cover Letter
Research Governance
Checklist for
all Principal
Investigations
Site specific
assessment and
research governance
National Health &
Medical Research
Council
National Health &
Medical Research
Council
Therapeutic Goods
Administration
Therapeutic Goods
Administration
Therapeutic Goods
Administration
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
Consultative Council for
Human Research Ethics
(Victorian Department
of Health
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
Consultative Council for
Human Research Ethics
(Victorian Department
of Health)
www.nhmrc.gov.au/Guidelines/publications/e72#PDF
www.nhmrc.gov.au/Guidelines/publications/r39
www.tga.gov.au/pdf/clinical-trials-handbook.pdf
www.tga.gov.au/pdf/clinical-trials-handbook.pdf
www.tga.gov.au/industry/clinical-trials-Guidelines.htm
www.health.vic.gov.au/cchre/about.htm
www.health.vic.gov.au/cchre/streamlining.htm#standard
www.health.vic.gov.au/cchre/downloads/ethics_checklist.pdf
www.health.vic.gov.au/cchre/applications/applications_how_to.htm
www.health.vic.gov.au/cchre/applications/applications_how_to.htm
www.health.vic.gov.au/cchre/downloads/research_checklist.pdf
www.health.vic.gov.au/cchre/applications_site_specific.htm
24 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Key References
Standard Forms & Templates
Form/Template Entity Link
National
Clinical Trial
Notification
Scheme Form
Victoria
National Ethics
Application Form
Victorian Specific
Module Form
Site Specific
Assessment Form
Standard Form of
Indemnity for
Clinical Trials
Therapeutic Goods
Administration
National Health &
Medical Research
Council
Department of Health
National Health &
Medical Research
Council
Medicines Australia
www.tga.gov.au/pdf/forms/clinical-trials-forms-ctn-notification.pdf
A National Health & Medical Research Council (NHMRC) form.
Available on the Australian Online Forms website, but preregistration
is required.
www.ethicsform.org/au
www.health.vic.gov.au/cchre/applications/applications_victorian_
specific.htm
A National Health & Medical Research Council (NHMRC) form.
Available on the Australian Online Forms website, but pre-registration
is required.
www.ethicsform.org/au
www.medicinesaustralia.com.au/issues-information/clinical-trials/
indemity-and-compensation-guidelines/
Standard Form of
Indemnity for a
Clinical Investigation
(Device Trials)
Standard Form of
Indemnity for a
Clinical Investigation
(Drug Trials)
Medical Technology
Association of Australia
Medicines Australia
www.mtaa.org.au/pages/page283.asp
www.medicinesaustralia.com.au/issues-information/clinical-trials/
indemity-and-compensation-guidelines/
Standard Form of
Indemnity for Clinical
Investigation (Device
Trials: HREC
Review only)
Standard Form of
Indemnity for Clinical
Investigation (Drug
Trials: HREC
Review only)
Medical Technology
Association of Australia
Medicines Australia
www.mtaa.org.au/pages/page283.asp
www.medicinesaustralia.com.au/issues-information/clinical-trials/
indemity-and-compensation-guidelines/
Standard Clinical Trial
Research Agreement
for Commercially
Sponsored Trials
Medicines Australia
www.medicinesaustralia.com.au/issues-information/clinical-trials/
clinical-trials-research-agreements/
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 25

Key References
Standard Forms & Templates
Form/Template Entity Link
Victoria
Standard Clinical Trial
Research Agreement
for Contract Research
Organisations
Standard Clinical Trial
Research Agreement
for Collaborative
Research Group
Studies
Standard Clinical
Investigation Research
Agreement (Devices)
for commercially
sponsored trials
Clinical Trial Research
Agreement: for
an Investigator
Initiated Study
Schedule 7 /
Schedule 4
Prescribed Form
Review Requests
Medicines Australia
Medicines Australia
Medical Technology
Association of Australia
VMIA
Queensland Health
www.medicinesaustralia.com.au/issues-information/clinical-trials/
clinical-trials-research-agreements/
www.medicinesaustralia.com.au/issues-information/clinical-trials/
clinical-trials-research-agreements/
www.mtaa.org.au/pages/page283.asp
This agreement has developed by VMIA as a guide for clients.
www.vmia.vic.gov.au/Risk-Management/Clinical-trials/clinical-trialresearch-agreements.aspx
www.health.qld.gov.au/ohmr/html/regu/for_researcher.asp
26 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

Attachment 1
Certificate of Currency Checklist
A commercial sponsor must ensure it has appropriate and adequate insurance with respect to its
responsibilities for a clinical trial and its indemnity obligations. The commercial sponsor must maintain
insurance that meets VMIA’s minimum insurance requirements for the entire period of the commercially
sponsored clinical trial. The commercial sponsor must provide evidence of current insurance upon request.
A commercial sponsor must provide to the VMIA Client a certificate of currency in a form that is
acceptable to the VMIA.
VMIA Minimum Insurance Requirements for
Commercially Sponsored Clinical Trials
Yes
No
The Certificate of
Currency must:
1. Detail the type of insurance – Public and Product Liability – or
equivalent such as General Liability or Clinical Trials Insurance.
2. Include as a named insured the full, legal name of the Australian
entity acting as a sponsor.
3. Be through an insurer either approved by the Australian Prudential
Regulation Authority, or a foreign insurer. All insurers are required
to hold Standard & Poor’s financial rating of not less than ‘A-’.
If the relevant insurer has a financial rating of less than ‘A-’, or specific
assistance is required to determine the financial rating, please contact
a VMIA Contact Officer via email clinicaltrials@vmia.vic.gov.au
4. Detail the period of insurance.
5. Provide insurance coverage for a minimum of A$10 million for
any one occurrence and in the annual aggregate.
6. Not contain an excess/deductible, or self insured retention
amount greater than A$25,000 for each and every claim or series
of claims arising out of one original cause.
When and what to submit – commercial sponsor’s certificate of currency
Pre-approval of the clinical trial
During the HREC approval process for new commercially sponsored clinical trials, VMIA Clients should complete the following:
1. review the commercial sponsor’s Certificate of Currency (CoC) provided by the sponsor against the VMIA Minimum
Insurance Requirements
2. submit the CoC to VMIA via email clinicaltrials@vmia.vic.gov.au if
a. there is any non-compliance with the VMIA Minimum Insurance Requirements or
b. assistance is required to obtain the financial rating of the commercial sponsor’s insurer with respect to requirement
number 3.
Approved clinical trials
When a commercially sponsored clinical trial has received Site Specific Authorisation (SSA), VMIA Clients should:
1. submit to VMIA via email clinicaltrials@vmia.vic.gov.au a copy of the:
a. SSA approval certificate (providing details of the name and the duration of the clinical trial); and
b. commercial sponsor’s CoC for the relevant trial, even if it has been previously submitted during the pre-approval process.
www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 27

Attachment 2
Submission of Information
Description
Copy of SUSAR report (submitted by VMIA client)
Schedule 7 / Schedule 4 Prescribed Form Request Review
(submitted by sponsor)
Copy of the Certificate of Currency (submitted by VMIA client)
Send to
susar@vmia.vic.gov.au
clinicaltrials@vmia.vic.gov.au
clinicaltrials@vmia.vic.gov.au
Additional Information
Area Contact Person Details
Insurance and Schedule 7 /
Schedule 4 Prescribed Form
Request Review
Risk Management
(advice for VMIA Clients)
VMIA Contacts
• Kirsty Ellis
• John Tippet
• Monia Choudhary
VMIA Client’s nominated Risk
Management Advisor
VMIA Telephone
03 9270 6900
VMIA Email
clinicaltrials@vmia.vic.gov.au
VMIA Telephone
03 9270 6900
VMIA Email
clinicaltrials@vmia.vic.gov.au
SUSARs • Samantha Reid VMIA Telephone
03 9270 6900
VMIA Email
susar@vmia.vic.gov.au
28 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

www.vmia.vic.gov.au