Clinical Investigations Research Agreements

Clinical Investigations Research Agreements (CIRA)

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 - Updated July 2017

2.      The MTAA Standard Indemnity Form for a clinical investigation

3.      The MTAA Indemnity Form for HREC review only

4.      The MTAA Compensation Guidelines

CIRAs for Clinical Research Organisations (CROs) will be made available soon. There are no specific CIRAs for Collaborative Research Groups (CRGs) being developed at this time.

The previous versions of the CIRA templates have been archived here.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

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:

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. The SEBS Committee meets monthly to review submitted variation requests, below are the closing dates for submissions along with the meeting dates for 2020:

Closing Dates for Submissions and Meeting Dates for 2020:

2020

Meeting Dates

COB 17 February 2020

26 February 2020

COB 16 March 2020

25 March 2020

COB 20 April 2020

29 April 2020

COB 18 May 2020

27 May 2020

COB 15 June 2020

24 June 2020

COB 20 July 2020

29 July 2020

COB 17 August 2020

26 August 2020

COB 21 September 2020

30 September 2020

COB 19 October 2020

28 October 2020

COB 16 November 2020

25 November 2020

COB 7 December 2020

16 December 2020