CLINICAL TRIALS - Western Health · The system applies to research involving interventional clinical trials, including drug and device trials that are investigator initiated, commercially

CLINICAL TRIALS –Insurance and Risk Management Guidelinesfor Clinical Trials conducted under the Therapeutic Goods Administration Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes

Version 2September 2012

Revision History

Version Location Amendment Notes

Version 2.0 September 2012

Application of the Guidelines pg 2 • 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)”.


Quick Reference Guide, pg 3 • Deleted row “Clinical Trails Advice Form” as no longer required.

• Amended last row to read “VMIA clients should use the Victorian Department of Health …”


Clinical Trials Governance, pg 4 • Replaced section titled “Reviewed by a Human Research Ethics Committee (HREC)


Streamlined System for ethical and scientific review of multi-site research in Victoria, pg 5

• Amended second paragraph from “A VMIA client must sign a …” to Public Hospital’s must sign a …”


Clinical Trials Sponsorship Table 2, pg 7

• Amended last section, 3rd bullet to “The clinical trial addresses relevant clinical questions”.

• Deleted 5th bullet point regarding Intellectual Property ownership


VMIA Minimum Insurance Requirements for Commercially Sponsored Clinical Trials, pg 8

• Amended introductory paragraphs

• Amended requirements 1 & 4

• Additional Guidance is provided below checklist.


Previously agreed Schedule 7 /Schedule 4 amendments, pg 19

• Amending contact details for previously agreed Schedule &/ Schedule 4’s.


Disclosure Obligations, pg. 21 • Clarified information regarding SUSAR notification


Clinical Trials Advice Form, pg 22 • Deleted entire page as CTAF is no longer relevant.


Key References, Standard Forms & Templates, pg 27

• Deleted last row regarding CTAF submission as no longer required.


Attachment 1, Clinical Trials Advice Form, pg 28

• Deleted CTAF as no longer required.


Attachment 2, Certificate of Currency Checklist, pg 29

• Amended introductory paragraphs

• Amended requirements 1 & 4

• Additional Guidance is provided below checklist


Attachment 3, Submission of Information, pg 30

• Deleted first row re submission of CTAF

• Deleted 3rd table re Department of Health contact details

ContentsIntroduction 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.

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.

Introduction

www.vmia.vic.gov.au 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines | 1

http://www.vmia.vic.gov.au

2 | 2012 CLINICAL TRIALS – Insurance and Risk Management Guidelines www.vmia.vic.gov.au

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




Quick Reference Guide

Key Points Description

Approval from VMIA There is no requirement to seek approval from VMIA for any aspect of a clinical trial

Insurance Requirements 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: [email protected]

HREC 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

SUSAR Reports 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:


Serious Adverse Events 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

National and Victorian Standards & Policies

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

Standard Agreements & Forms

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

Amendments to the approved Clinical Trial Research Agreements

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:


VMIA will forward the proposed amendments to the Southern and Eastern Border States (SEBS) Committee for review

Participant Information & Consent Forms

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


mailto:[email protected]




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 TrialsVictoria 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.



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.

Clinical Trials Governance



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


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


Use standard indemnity form for a Clinical Investigation on Medical Technology Association of Australia website



Contract Research Organisation (CRO) – acting as the local sponsor

Clinical Trial Research Agreement – CRO specific



Use standard indemnity form on Medicines Australia website



Research Studies

Collaborative or Cooperative Research Group (CRG)

Clinical Trial Research Agreement – CRG specific


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.

Investigator Initiated Study (IIS)

Clinical Trial Research Agreement – IIS specific

A guideline agreement is available on the VMIA website

Guidance on how the types of sponsorships are categorised is provided in Table 2.



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.

Clinical Trials Sponsorship



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 [email protected]

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 [email protected] 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 [email protected] 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.






Non-compliance with the VMIA’s Minimum Insurance Requirements for Commercially Sponsored Clinical TrialsIn 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 [email protected]

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 [email protected]. 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.

The VMIA’s Minimum Insurance Requirements for Commercially Sponsored Clinical Trials





The VMIA’s Indemnity Requirements for Clinical Trials

Risk and liability for commercial and research study sponsorsTo 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 trialResearch 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 trialThe 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



Indemnity arrangements for HREC review only of the clinical trialThere 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 trialIt 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.

The VMIA’s Indemnity Requirements for Clinical Trials



Non-standard indemnity arrangementsIf 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 [email protected]

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 [email protected]

The FTIH Protocol is also accessible on the VMIA website at www.vmia.vic.gov.au

The VMIA’s Minimum Requirements for Clinical Trials






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.



Table 4

Type of Trial/Study Description and relevant agreement

Commercially-Sponsored Trials of a Pharmaceutical

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 ‘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.




Table 4 continued


Contract Research Organisation (CRO) acting as the Local Sponsor

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 ‘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 ‘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.





For an Investigator Initiated Study

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)

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.

Non-Commercial

International

Sponsorship

Arrangements

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.

Table 4 continued





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 [email protected]

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 4To 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.




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 [email protected].

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.





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 amendmentsVMIA clients can obtain a schedule of previously agreed Schedule 7 / Schedule 4 clauses with specific commercial sponsors from the Victorian Department of Health.




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 samplesIf 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.

RadiationIf 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.

PregnancyIf 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.



Disclosure Obligations

VMIA’s Notification ObligationsPreviously 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 [email protected].

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.




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.



Key Elements of the Risk Management Process

Establish the ContextUnderstand the external, internal and

context in which clinical trials risk process will take place. Ensure there is appropriate

criteria to assess the risks.

Identify RisksIdentify where, when, why and how a risk could impact patient safety, the objective of the clinical trial and the

organisation’s objectives.

Analyse RisksIdentify and evaluate existing controls

for identified risks. Assess the consequences and likelihood and

determine the risk rating.

Evaluate RisksCompare 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.

Treat RisksNot 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.

Communicate & Consult

Communicate and consult with all

relevant stakeholders at each stage of the

risk management process.

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.

Adapted from the Australian/New Zealand Risk Management Standard.



Key References

Policies and Guidelines

Document Entity Link

National

National Statement on Ethical Conduct in Human Research 2009

National Health & Medical Research Council

www.nhmrc.gov.au/Guidelines/publications/e72#PDF

Australian Code for the Responsible Conduct of Research 2007


www.nhmrc.gov.au/Guidelines/publications/r39

Note for Guidance on Good Clinical Practice

Therapeutic Goods Administration

www.tga.gov.au/pdf/clinical-trials-handbook.pdf

The Australian Clinical Trial Handbook 2006


www.tga.gov.au/pdf/clinical-trials-handbook.pdf

Access to Unapproved Therapeutic Goods – Clinical Trials in Australia 2004


www.tga.gov.au/industry/clinical-trials-Guidelines.htm

Victoria

Streamlined Ethical Review of Multi-Site Clinical Trials

Consultative Council for Human Research Ethics (Victorian Department of Health)

www.health.vic.gov.au/cchre/about.htm

Standard Operating Procedures for Victoria’s Central Ethics Review System for Multi-Site Clinical Trials

Consultative Council for Human Research Ethics (Victorian Department of Health

www.health.vic.gov.au/cchre/streamlining.htm#standard

Ethics Checklist for Coordinating Principal Investigators


www.health.vic.gov.au/cchre/downloads/ethics_checklist.pdf

How to make a HREC application


www.health.vic.gov.au/cchre/applications/applications_how_to.htm

HREC Application Cover Letter


www.health.vic.gov.au/cchre/applications/applications_how_to.htm

Research Governance Checklist for all Principal Investigations


www.health.vic.gov.au/cchre/downloads/research_checklist.pdf

Site specific assessment and research governance


www.health.vic.gov.au/cchre/applications_site_specific.htm


http://www.nhmrc.gov.au/Guidelines/publications/e72#PDF

http://www.nhmrc.gov.au/Guidelines/publications/r39

http://www.tga.gov.au/pdf/clinical-trials-handbook.pdf

http://www.tga.gov.au/pdf/clinical-trials-handbook.pdf

http://www.tga.gov.au/industry/clinical-trials-Guidelines.htm

http://www.health.vic.gov.au/cchre/about.htm

http://www.health.vic.gov.au/cchre/streamlining.htm#standard

http://www.health.vic.gov.au/cchre/downloads/ethics_checklist.pdf

http://www.health.vic.gov.au/cchre/applications/applications_how_to.htm

http://www.health.vic.gov.au/cchre/applications/applications_how_to.htm

http://www.health.vic.gov.au/cchre/downloads/research_checklist.pdf

http://www.health.vic.gov.au/cchre/applications_site_specific.htm


Standard Forms & Templates

Form/Template Entity Link

National

Clinical Trial Notification Scheme Form


www.tga.gov.au/pdf/forms/clinical-trials-forms-ctn-notification.pdf

Victoria

National Ethics Application Form


A National Health & Medical Research Council (NHMRC) form. Available on the Australian Online Forms website, but pre-registration is required.

www.ethicsform.org/au

Victorian Specific Module Form

Department of Health www.health.vic.gov.au/cchre/applications/applications_victorian_specific.htm

Site Specific Assessment Form


A National Health & Medical Research Council (NHMRC) form. Available on the Australian Online Forms website, but pre-registration is required.

www.ethicsform.org/au

Standard Form of Indemnity for Clinical Trials

Medicines Australia www.medicinesaustralia.com.au/issues-information/clinical-trials/indemity-and-compensation-guidelines/

Standard Form of Indemnity for a Clinical Investigation (Device Trials)

Medical Technology Association of Australia

www.mtaa.org.au/pages/page283.asp

Standard Form of Indemnity for a Clinical Investigation (Drug Trials)


Standard Form of Indemnity for Clinical Investigation (Device Trials: HREC Review only)

Medical Technology Association of Australia


Standard Form of Indemnity for Clinical Investigation (Drug Trials: HREC Review only)


Standard Clinical Trial Research Agreement for Commercially Sponsored Trials

Medicines Australia www.medicinesaustralia.com.au/issues-information/clinical-trials/clinical-trials-research-agreements/

Key References


http://www.tga.gov.au/pdf/forms/clinical-trials-forms-ctn-notification.pdf

http://www.ethicsform.org/au

http://www.health.vic.gov.au/cchre/applications/applications_victorian_

http://www.ethicsform.org/au

http://www.medicinesaustralia.com.au/issues-information/clinical-trials/

http://www.mtaa.org.au/pages/page283.asp






Standard Forms & Templates

Form/Template Entity Link

Victoria

Standard Clinical Trial

Research Agreement

for Contract Research

Organisations

Medicines Australia www.medicinesaustralia.com.au/issues-information/clinical-trials/

clinical-trials-research-agreements/

Standard Clinical Trial

Research Agreement

for Collaborative

Research Group

Studies

Medicines Australia www.medicinesaustralia.com.au/issues-information/clinical-trials/

clinical-trials-research-agreements/

Standard Clinical

Investigation Research

Agreement (Devices)

for commercially

sponsored trials

Medical Technology

Association of Australia


Clinical Trial Research

Agreement: for

an Investigator

Initiated Study

VMIA This agreement has developed by VMIA as a guide for clients.

www.vmia.vic.gov.au/Risk-Management/Clinical-trials/clinical-trial-

research-agreements.aspx

Schedule 7 /

Schedule 4

Prescribed Form

Review Requests

Queensland Health www.health.qld.gov.au/ohmr/html/regu/for_researcher.asp

Key References





http://www.vmia.vic.gov.au/Risk-Management/Clinical-trials/clinical-trial-research-agreements.aspx



http://www.health.qld.gov.au/ohmr/html/regu/for_researcher.asp


Attachment 1Certificate 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 [email protected]

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 [email protected] 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 [email protected] 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.






Attachment 2Submission of Information

Additional Information

Description Send to

Copy of SUSAR report (submitted by VMIA client) [email protected]

Schedule 7 / Schedule 4 Prescribed Form Request Review (submitted by sponsor)

[email protected]

Copy of the Certificate of Currency (submitted by VMIA client) [email protected]

Area Contact Person Details

Insurance and Schedule 7 / Schedule 4 Prescribed Form Request Review

VMIA Contacts

•KirstyEllis

•JohnTippet

•MoniaChoudhary

VMIA Telephone 03 9270 6900

VMIA Email [email protected]

Risk Management (advice for VMIA Clients)

VMIA Client’s nominated Risk Management Advisor

VMIA Telephone 03 9270 6900


SUSARs •SamanthaReid VMIA Telephone 03 9270 6900









www.vmia.vic.gov.au


Documents

CLINICAL TRIALS - Western Health · The system applies to research involving interventional clinical trials, including drug and device trials that are investigator initiated, commercially