Multi-Centre Research Projects

Multi-Centre Research
Western Health is an accepting site for the Consultative Council for Human Research Ethics ( CCHRE).Please refer to the CCHRE website for details of the streamlined ethical review process established by the Department of Health. www.health.vic.gov.au/cchre
All projects reviewed under the multi-centre research umbrella are required to submit a Research Governance application (Site Specific Approval) to the Office for Research.

  • Elements of Research Governance
  • Ethics approval
  • Compliance with legislation, regulations, guidelines and codes of practice.
  • Legal and Insurance - consent, indemnity, contracts.
  • Financial management and site-specific assessment.
  • Policies and procedures for responsible research conduct and managing research misconduct.
  • Managing collaborative research.
  • Reporting

Site-Specific Assessment (SSA) is a key element of research governance, which spans a number of the elements listed above.
As a result of the introduction of streamlined ethical review of multi-site clinical trials in Victoria, the Office for Research has introduced new procedures for the submission and review of all research projects at Western Health. These new procedures include the requirement to make separate submissions one to Melbourne Health for ethical review and one to Western Health for research governance/site-specific assessment. 
The instructions below apply to all research projects conducted at or by Western Health.

1.  Complete the Research Governance Checklist
2.  Submit an Explanatory Cover Letter
3.  Submit a Victorian Site-Specific Assessment form 
4.  Pay the Research Governance / Site-Specific assessment fee
5.  Submit a project budget 
6.  Complete the Western Health Site-Specific Form and departmental forms
7.  Clinical Trials documentation required 
8.  Research Collaboration Agreement
9.  Material Transfer Agreement
10. Submit your Research Governance / Site-Specific Assessment Application
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  1. Complete the Research Governance Checklist for all principal investigators.
  2. Submit an explanatory cover letter with your Research Governance/ Site-Specific Assessment application. Please address this cover letter to Dr Tam C Nguyen - Research Governance & Ethics
  3. Submit a completed Victorian Site-Specific Assessment (SSA) Form with original signatures of all Western Health Researchers. Note: A SSA form must be generated after you have generated a NEAF application form for a project from the https://www.ethicsform.org/au  website only.
  4. Include the applicable fee for research governance/site-specific assessment. Fees are payable upfront at the time of submission of your research governance/site-specific assessment application.
  5. Submit a project budget
  6. Complete the Western Health Site-Specific Form and also a Statement of Approval Form for each Western Health department whose services will be required to undertake your research. Note: A signed Statement of Approval form from PHARMACY is mandatory for all studies involving the use of drugs.  Also complete the forms below as they apply to your research project:
    • An Approval to Examine Records for the Purposes of Research Form Link- for any person who will be accessing Western Health patient records and is not an employee of Western Health (eg trial monitor or external researcher).
    • A Health Information Services Accounting Agreement and Additional Information Form - for studies requiring the services of the Health Information Services/Medical Records department. 
    • Pathology Form- for studies requiring the services of the Dorevitch Pathology Service. 
  7. For all Clinical Trials - submit the following, as applicable:
    • A CTN or CTX form 
    • Three (3) original copies of the Clinical Trial Research Agreement (CTRA) signed by the sponsor and principal investigator.  Please visit the Financial Management of Research web page for information regarding invoicing and payment clauses to be included in the clinical trial research agreement.

    VMIA (Insurer of public hospitals in Victoria) together with Medicines Australia, have developed a suite of templates for CTRAs. Please complete the CTRA template that is most suited to the circumstances of the trial in question. Note: For all CTRAs to which Western Health is a party, complete the "Institution" details on page one as follows:  

    Name: Western Health
    Address: 176 Furlong Rd, St Albans VIC 3021
    ABN: 61 166 735 672
    Contact for Notices: Director, Office for Research
    Fax for Notices: 61 3 83958259
    Phone Number: 61 3 8395 8073

    • Insurance Certificate - For commercially sponsored clinical trials, submit a copy of the sponsor's certificate of insurance. This should comply with the requirements for clinical trials insurances as outlined in the VMIA Guidelines for Clinical Trials for Victorian Public Hospitals.  
    • Indemnity - Required for commercially sponsored clinical trials
      o Drug Trials - Two (2) copies each of the Standard Medicines Australia Form of Indemnity for Clinical Trials and HREC Review Only Medicines Australia Form of Indemnity For Clinical Trials as applicable.
      o Device Trials - Two (2) copies each of the Standard Medical Technology Association of Australia Form of Indemnity for Clinical Investigation and HREC Review Only Medical Technology Association of Australia Form of Indemnity for Clinical Investigation as applicable. 

    Note: For all indemnities given by sponsors to Western Health, please complete the "To" or ("the Indemnified Party") section on page one as follows:
    Name: Western Health
    ABN: 61 166 735 672
    Address:  176 Furlong Rd, St Albans VIC 3021

    Submit one (1) copy of the Investigator's Brochure.

  8. For Collaborative Research Across Institutions (research other than clinical trials) - submit a Research Collaboration Agreement.
    In accordance with the Australian Code for the Responsible Conduct of Research, organisations involved in a joint research project should ensure that agreement is reached with the partners on the management of the research. This agreement should be in writing. Researchers may use the template developed by Western Health for this purpose or may use an agreement developed by a collaborating partner.

  9. Complete a material transfer agreement if applicable.

  10. Submit your research governance/ site-specific assessment application (original plus one hard copy, PLUS one complete e-copy) to:
    Office for Research
    Level 3 Centre for Health Research & Education - Sunshine Hospital,
    Furlong Road, St Albans VIC 3021
    Submit the e-copy of your research governance/site-specific assessment application to: ethics@wh.org.au