Section 3: For projects that involve collaboration with any other organisation

I need an agreement - what do I do?

For collaborations where the RMH initiates the project, contact the Governance Office. 

Where the collaborating organisation wrote the study protocol, the RMH will consider the collaborator's agreement template. If the collaborator does not have a suitable template, contact the Governance Office.

What if my study is a clinical trial?

For clinical trials involving medicines, biologicals and/or devices, follow the instructions below in Section 5a. Drug and/or Device Clinical Trial Documentation.

RMH-specific information for Agreements

For agreements, use the information below to describe the legal entity and business details.

Submit the unsigned draft agreement in the SSA Application

A draft copy of the relevant agreement should be submitted in MS Word format for review and comment to the Office for Research as part of your Site Specific Application. The Office for Research will organise RMH legal review, where required, on your behalf based on the application.

Signing agreements

On acceptance of terms by all parties, forward the agreement to the Office for Research for execution by the RMH authorised representative.

Other agreements commonly utilised in clinical research

Common agreement types and uses are listed below.

• Research Collaboration Agreement (RCA): When two or more parties are collaborating on a research project
• Clinical Trials Research Agreement (CTRA): For use in commercially sponsored Clinical Trials (Medicines Australia and MTAA templates)
• Collaborative Research Group Clinical Trials Research Agreement (CRG CTRA): For use multi-site investigator initiated Clinical Trials (Medicines Australia and MTAA templates). 
• Data Transfer Agreement (DTA): One way data only transfer from one party to another. 
• Material Transfer Agreements (MTA): One way transfer of materials (may also include associated data) from one party to another.