Research Contracts and Agreements

Research agreements are required when the Sponsor is external to Northern Health and should be coordinated by the Northern Health contact person or Principal Investigator.

Research agreements are not required to be submitted as part of an ethics submission however are required for the Northern Health governance submission

Details for Northern Health contracts:

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

Agreement/Indemnity Form Templates

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

Sourced: Medicines Australia website, accessed Apr16

Approved Northern Health 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.

To download a copy of the Northern Health Memorandum of Understanding, click here

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.

To download a copy of the Northern Health Service Level Agreement, click here.

Simple Collaborative Agreement used for investigator initiated research that involves a financial transaction between parties.

To download a copy of the Northern Health Collaborative Agreement, click here.

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.

To download a copy of the Northern Health Material Transfer Agreement, click here.

Approval to examine records for the purpose of research (external researchers wishing to access NH patient records must complete this form).

For external researchers and monitors requesting access to Northern Health Clinical Patient Folder (ie: electronic medical record).

To download a copy of the Northern Health Approval to Examine Records of the Purpose of Research, click here.

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.

To download a copy of the Northern Health Confidentiality Deed, click here.

The MACH Research Collaboration Agreement was developed with our partners to facilitate quick sign off for collaborative research within our member organisations. If you are a Northern Health researcher collaborating with other researchers from the list below, this agreement may be used.

  • 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

To download a copy of the MACH Research Collaboration Agreement, click here.

MACH Research Collaboration Agreement (Non-Commercial) – Guidelines for Use

If you think your research project requires a different agreement, contact ethics@nh.org.au