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 South Eastern Border States (SEBS) Committee comprising of the NSW, QLD, VIC, SA and TAS Health Departments. 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The previous versions of the CIRA templates have been archived here.

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 SEBS Committee to avoid individual review at each study site at the time of research governance review.

The SEBS Committee 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 SEBS 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 SEBS Committee, which is below:

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

The completed variation request template should initially be submitted to Health Ethics Unit, NSW Health, who will coordinate with other members of the SEBS Committee:

Initial Contact Point for Submissions:

• Phone – (02) 9461 7389
• SEBS email address – MOH-SEBS@health.nsw.gov.au.

Please forward all contract variation requests to the above email and the SEBS secretariat will appoint a Committee Member as the liaison officer for that request. The SEBS Committee meets monthly to review submitted variation requests, below are the closing dates for submissions along with the meeting dates for 2021: