The VMIA, in collaboration with interstate health departments and industry agencies, has developed a set of uniformly accepted standard Clinical Trial Research Agreements (CTRAs). These agreements accommodate the individual local sponsor and international organisation operational requirements through the nominated schedule.
The CTRA is between the local sponsor and the investigating institute. The local sponsor is the Australian entity that endorses the Clinical Trial Notification Scheme (CTN) application.
The sponsor of the trial is the company, institution or organisation that takes overall responsibility for the conduct of the trial and usually initiates, organises and supports the trial. The sponsor of the trial should be an Australian company or entity.
The defined Australian entity that endorses the CTN application is the local sponsor. In this capacity they must provide the indemnity and required insurance provisions for the conduct of the clinical trial.
^ Back to the top
VMIA Investigator Initiated Agreement
The VMIA Investigator Initiated Agreement has been developed for investigator initiated clinical trials which can not be accommodated under the Collaborative Research Group (CRG) CTRA.
The VMIA Investigator Initiated Agreement is to be used when your institute is either engaging or is being engaged to conduct an investigator initiated clinical trial. It does not constitute the agreement between the pharmaceutical company and your institute for the provision of product and/or financial support.
VMIA Investigator Initiated Agreement [DOC 181, KB]
^ Back to the top
Commercially sponsored CTRA
The commercially sponsored clinical trial agreement is to be used when an Australian pharmaceutical company or the Australian subsidiary of an international pharmaceutical company providing the investigational product acts as the local sponsor for the purposes of the clinical trial.
The commercially sponsored CTRA is between the local sponsor and the investigating institute.
Note: At no stage should the body of the Commercially Sponsored CTRA be altered or amended in any way. Any changes that may be required to the Agreement to accommodate operational specific requirements should be captured and declared within Schedule 7.
^ Back to the top
Corporate research organisation CTRA
The corporate research organisation (CRO) CTRA is to be used when the international organisation as owner of the investigational product engages a CRO to act as the Australian entity for the purposes of the CTN application. The CRO is then defined as the local sponsor and assumes all responsibilities and obligations that attach to a local sponsor.
As the local sponsor, the CRO must:
- Provide the Medicines Australia Form of Indemnity.
- Provide appropriate insurance. - It is acceptable for the CRO to be a named additional insured under the international organisation’s insurance policy.
- The CRO as local sponsor may subcontract certain key functions of the clinical trial to another entity. Under Schedule 7, the CRO CTRA can utilise the subcontracting clause provided below.
^ Back to the top
Collaborative research CTRA
The collaborative research agreement (CRG CTRA) is to be used when a collaborative/cooperative group is the sponsor of the clinical trial.
The CRG as local sponsor may subcontract certain key functions of the clinical trial to another entity. Under Schedule 4, the CRG CTRA can utilise the subcontracting clause below.
Schedules 7 and 4
Schedules 7 and 4 are to be utilised for the introduction of sponsor unique operational requirements that are required to be executed in order to allow for the conduct of the clinical trial.
Schedule 7 and 4 are not to be used to substantially amend the CTRA or to introduce provisional clauses which contradict or otherwise undermine the substantial provisions and spirit of the Agreement.
The VMIA has pre-approved a number of Schedule 7 requests from industry for the commercially sponsored CTRA. The approved Schedule 7 clauses have been issued to both the health services and the respective pharmaceutical company. The CTRA must only contain the Schedule 7 accepted clauses that have been issued to the pharmaceutical company as approved by the VMIA.
Subcontracting
The following amended subcontracting clause can be inserted into Schedule 7 for the CRO CTRA and Schedule 4 of the CRG CTRA.
- The sponsor may subcontract any of its obligations under this agreement, save for the obligations set out in clauses 5.1(8), 5.1(9) and 5.1(10) of the agreement. The sponsor remains responsible for all subcontracted obligations and is liable for all acts and omissions of any subcontractor as if they were the sponsor's acts and omissions.
- No subcontractor will have any rights under this agreement against the institution or be entitled to receive any payment from the institution.
Collaborative research agreement [DOC 194 KB]
^ Back to the top
Standard Clinical Investigation Research Agreement (CIRA) for use in device trials
The Medical Technology Association of Australia's (MTAA) CIRA is to be used by Victorian Public hospitals when they are engaged by a device company to conduct a human trial involving their product. It has been developed in conjunction with the Medical Technology Association of Australia (MTAA), the VMIA, NSW Department of Health and Queensland Health (DoH).
This agreement has been developed specifically to address the requirements that attach to a device trial which otherwise could not be accommodated for via the other CTRAs currently in place. The CIRA has adopted the same format as per existing CTRAs, bar for industry specific nomenclature of which the title of the agreement is a primary example. Standard clinical investigation research agreement.
Further information
To find out more about the VMIA’s clinical trial research agreements, please contact our Risk Management Team on 03 9270 6900 or by email risk.info@vmia.vic.gov.au.