Agreement templates

Clinical Trial Preparation Agreement ("Pre-Nup")

This can be used to cover the start-up fee and should be signed before or during the ethics review, before the main agreement is executed.

Device Trials

Templates are available from Medical Technology Association of Australia (MTAA)

• MTAA Standard Clinical Investigation Research Agreement (CIRA)
• MTAA CIRA: Standard Clinical Investigation Research Agreement Post Market
• MTAA CIRA: Contract Research Organisation (CRO) acting as the Local Sponsor
• MTAA CIRA: Post Market Clinical Trial (Medical Devices) – Contract Research Organisation (CRO) acting as Local Sponsor

Checklist

A checklist has been developed for researchers to check the agreement and indemnity, if applicable, before they are submitted to the Office of Ethics and Research Governance.

If the checklist highlights any of the details as incorrect, please arrange corrections prior to submission of the documents.

The checklist does not apply to the investigator-initiated, company supported study template.

Investigator-initiated, company supported studies

For use in Alfred Health investigator-initiated studies where a company is providing support (funding, investigational product).

Research Collaboration Agreement (RCA)

To be used for non-interventional, investigator-initiated, collaborative, research projects. The template has been developed by the Victorian Research Translation Centres.

The guidelines provide information on suitable research projects and instructions on how to complete the template.

Material Transfer Agreements (MTA)

A MTA governs the exchange of materials between two organisations, usually for research purposes and should be used for the transfer of tissue and other material. There are two types of MTAs: incoming and outgoing. An outgoing MTA is used when Alfred Health is providing materials to an external organisation.

An incoming MTA is provided by the relevant institution to an Alfred Health researcher requesting materials from an external source.

Data Transfer Agreements (DTA)

The data transfer agreement is more suitable when Alfred Health is just contributing already collected data, which another institution will analyse/publish. Alfred Health will receive credit for contributing the data but is otherwise not involved in aspects of the conducting the protocol/proposal.

Amendments or Addenda to Agreements

Once the Agreement has been signed, any revisions to the Agreement are done via Amendment or Addendum to the Agreement. Many Sponsors have their own template. Alfred Health has created a template which can be used if the Sponsor does not have a template.

Tele-trial Agreements

The tele-trial sub-contract is for use between a primary site and a satellite site in a commercially sponsored trial.