Research agreements/contracts are required when the Sponsor is external to Northern Health or if there is collaboration with parties outside of Northern Health. Agreements and contracts should be coordinated by the Northern Health contact person or Principal Investigator.

PLEASE NOTE: All contracts and agreements must first be submitted to RDGU NOT Northern Health Legal

Details for Northern Health contracts:
Northern Health
185 Cooper St, Epping VIC 3076
ABN: 42 986 169 981

Medicines Australia standard contracts will not be accepted where changes to any clause within the contract have not been approved. Northern Health approved contract clauses are not to be change without approval from Northern Health Contracts Manager and Legal Counsel.

Type of Sponsorship Research Agreement Form Indemnity Forms
                                                   COMMERCIAL TRIALS                
Commercially Sponsored Trial of a Pharmaceutical Clinical Trial Research Agreement – Standard Form
Available on Medicines Australia website		 Standard Indemnity Form on Medicines Australia website
Commercially Sponsored Trial of a Device Clinical Investigation Research Agreement – Standard Form
Available on Medical Technology Association of Australia website		 Standard Indemnity Form for a Clinical Investigation on Medical Technology Association of Australia website
Contract Research Organisation (CRO) acting as the local Sponsor Clinical Trial Research Agreement – CRO specific
Available on Medicines Australia website		 Standard Indemnity Form on Medicines Australia website
                                                      NH RESEARCH STUDIES
Collaborative or Cooperative Research Group (CRG) Clinical Trial Research Agreement – CRG specific
Available on Medicines Australia website		 Both the CRG and IIS standard agreements have the same general ‘liability and insurance’ clause. The intent of the clause is that each party is liable for its acts and omissions in relation to the conduct of the study. Therefore indemnity forms not required.As above
Investigator Initiated Study (IIS) Clinical Trial Research Agreement – IIS specific
Available from the Coordinating Office for Clinical Trial Research, Department

Northern Health Approved Agreements

  • Memorandum of Understanding to be used for low risk research or quality improvement project collaborations that do not involve a financial transaction between parties, eg: student projects.
  • Service Level Agreement to be used where Northern Health is only partially involved in a research project, eg: where participants are being recruited and all other research activities are taking place off-site. Depending on the type of research project, a Site-Specific Application form may still be required.
  • Material Transfer Agreement to be used where NH provides external parties with materials such as tissue samples obtained by NH, and NH’s only role is to provide this material and is not involved as a collaborator in the research project.
  • Data Transfer Agreement to be used when NH provides external parties with data obtained by NH, and NH’s only role is to provide data, and is not involved as a collaborator in the research project.
  • Approval to examine records for the purpose of research. For external researchers and monitors requesting access to Northern Health Clinical Patient Folder (ie: electronic medical record)
  • Research – Confidentiality Deed -is to be used when a Northern Health employee is extracting and sending identifiable personal and/or health information to an external researcher.
  • The MACH Research Collaboration Agreement was developed with our partners to facilitate quick sign off for collaborative research within our member organisations. This is our preferred template to use when a Northern Health researcher is collaborating with other researchers from MACH (listed below) and non-MACH partners.
    • Austin Health
    • Melbourne Health
    • Peter MacCallum Cancer Centre
    • Royal Children’s Hospital
    • St Vincent’s Hospital (Melbourne)
    • Florey Institute of Neuroscience and Mental Health
    • Murdoch Children’s Research Institute (MCRI)
    • Northern Health
    • Royal Women’s Hospital
    • University of Melbourne
    • Walter and Eliza Hall Institute
    • Western Health

Please visit Library of Resources to download a copy of the agreements.