Clinical Investigation Research Agreements

Clinical Investigation Research Agreements

MTAA have developed a suite of Clinical Investigation Research Agreements (CIRAs) for commercially sponsored studies of medical technology.

The agreements have been developed in cooperation with the National Clinical Trial Agreement (NaCTA) Panel previously known as SEBS comprising representatives from all states and territories.  The Clinical Investigation Research Agreements and associated forms have been based on similar documentation developed by Medicines Australia.

An important distinction between CIRAs developed for the pharmaceutical and the medical technology industries is the use of the international standard ISO 14155 for the study of medical technology. The MTAA agreements reference this standard.

The agreements, forms of indemnity and compensation guidelines are available by clicking the link below:

1. The MTAA Standard Clinical Investigation Research Agreement (CIRA)
2. The MTAA CIRA: Standard Clinical Investigation Research Agreement Post Market
3. The MTAA CIRA: Contract Research Organisation acting as the Local Sponsor
4. The MTAA CIRA: Post Market Clinical Trial (Medical Devices) – Contract Research Organisation acting as Local Sponsor
5. The MTAA Standard Indemnity Form for a Clinical Investigation
6. The MTAA Indemnity Form for HREC review only
7. The MTAA Compensation Guidelines

The previous versions of the CIRA templates have been archived here.

Western Australia Clinical Investigations Research Agreements

1. WA Health - MA Clinical Trial Research Agreement – Standard (Form A)
2. WA Health - MA Clinical Trial Research Agreement – Collaborative or Cooperative Research Group (CRG) Studies (Form C)​
3. WA Health - MA Clinical Trial Research Agreement – Contract Research Organisation acting as Local Sponsor (Form D)
4. WA Health - MA Clinical Trial Research Agreement – Phase IV Clinical Trial (Form E)
5. WA Health - MA Clinical Trial Research Agreement - Phase IV Clinical Trial Contract Research Organisation acting as Local Sponsor (Form F)
6. WA Health - MTAA Clinical In​vestigation Research Agreement - Standard (CIRA)
7. WA Health – Sponsor, CRO & Institution CTRA

Documents sourced from Western Australia Department of Health. The version history of WA Health's Research Agreement templates can be viewed here.

Guidance for seeking amendments to the Clinical Investigations Research Agreements

The body of the CIRA should not be altered in any way. Any company-specific amendments to the CIRA are to be made exclusively via changes to Schedule 7 of the CIRA. These amendments can be pre-approved by the NaCTA Panel to avoid individual review at each study site at the time of research governance review.

The NaCTA Panel will consider CIRA amendments that are intended to accommodate (to an extent) company-specific clauses that clarify or add to the CIRAs. Please note that NaCTA will not accept amendments that:

• are clearly contrary to, or attempt to modify, the core provisions of the CIRAs;
• seek to delete or substantially modify the essential clauses of the CIRAs. These include the provisions surrounding Publication, Confidentiality, Intellectual Property, Governing Law and Termination;
• merely restate (or “wordsmith”) the existing provisions of the CIRAs;
• seek to override the applicability of the CIRAs;
• are contrary to government insurance arrangements or seek to require the Institution to have certain types of insurance. All Public Health Institutions in Australia have standard insurance arrangements that apply to the whole of the Government sector for each State;

A request template for amendment of a CIRA has been developed by the NaCTA Panel, which is below:

• Template to request a Schedule 7 variation to a CIRA (NaCTA Review Template)
• Statement of Purpose for NaCTA​​​​​​

Initial Contact Point for Submissions:

• Phone – (08) 71172225
• NaCTA email address – Health.NaCTA@sa.gov.au

Please forward all contract variation requests to the above email and the NaCTA secretariat will appoint a Panel Member as the liaison officer for that request. The NaCTA Panel meets monthly to review submitted variation requests, below are the closing dates for submissions along with the meeting dates for 2024:

Closing Dates for Submissions and Meeting Dates for 2024