Research

Research Agreements and Confidential Disclosure Agreement's (including CTRAs, RCAs, MTAs & MOUs)

There are a number of regulatory documents that are required as part of a research project, research including agreements, insurance and indemnities.

Please follow attached flowchart to determine what agreement/s may be required as part of your research project submission. Please note this is as 3 step process. You MUST follow each step in the process.

Any research involving collaboration between Austin Health and an external entity requires an agreement of some description. The nature of the research project will determine which type of agreement is required. All agreements should be accompanied by a completed Cover Sheet, Database Form and signed Contract Checklist*

* This document should be signed by Austin line manager and Austin Finance Resource Manager in section 1 as well as the Austin Responsible Executive Director in section 6

 

Agreement Type

When should this agreement be used

Requirements

Austin Audit Memorandum of Understanding

Audit Activities not involving money

1 x signed & executed e-copy

MACH Simple Research Collaboration Agreement

Investigator Initiated research collaborations between two or more MACH members. It accommodates the parties making “Materials” available for research collaborations and for small to medium amounts of funds to be expended by the parties.

Please find MACH partner list here:

http://mach.melbourne/about/our-partners/

2 x wet inked signed hard copy

Austin Simple Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects not involving money

2 x wet inked signed hard copy

Austin Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects involving money where Austin is the lead collaborator

2 x wet inked signed hard copy

Austin Research Collaboration Agreement

Non-sponsored Low Negligible Risk Research projects involving money where Austin is not the lead collaborator

2 x wet inked signed hard copy

Victorian Managed Insurance Authority (VMIA) Investigator Initiated Clinical Trial Research Agreement

Investigator Initiated studies that require full review by the Austin Human Research Ethics Committee

2 x wet inked signed hard copy

Austin Material Transfer Agreement

Investigator Initiated studies that involve transfer of data/samples for analysis at another location other than Austin Health

2 x wet inked signed hard copy

Medicines Australia Clinical Trial Research Agreement

Sponsored studies that require full review by the Austin Human Research Ethics Committee

3 x wet inked signed hard copy

National Health and Medical Research Council Multi-Institutional Agreement

National Health and Medical Research Council funded studies involving multiple institutions

1 x signed & executed e-copy

Austin Health and UoM Schedule C Undertaking

 

For signing by each UoM student prior to commencement of ANY research project at Austin Health.

1 x signed copy

 

Confidential Disclosure Agreement

If you require a Confidential Disclosure Agreement (CDA) or Confidentiality Agreement/Non-Disclosure Agreement to be signed please add this additional signature block to the agreement and email to ethics@austin.org.au to process and then arrange the authorised delagated signatory.