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Delivering a Healthy WA
State Health Research Advisory Council

Clinical Trial Agreements and Indemnity

A standard, system-wide approach to the agreements and indemnities applying to clinical trials conducted in Western Australian public sector hospitals and health services is now in place.

Consistent with other state and territory jurisdictions, the following three template agreements are used by WA Health:

  1. Clinical Trial Research Agreement – Medicines Australia – Standard Form
  2. Clinical Trial Research Agreement – Medicines Australia Form: Contract Research Organisation acting as the Local Sponsor
  3. Clinical Trial Agreement – Collaborative or Cooperative Research Group (CRG) Studies – Standard Form

Each of these agreements provides for amendments to be made to the terms presented in the body of the agreement. In accepting these nationally consistent templates, WA Health has specified a number of amendments to be included in the relevant schedule to the agreement.

In addition to the above template agreements, WA Health also uses a variant of the Medicines Australia Standard Form for use in trials requiring a tripartite agreement involving the institution, sponsor and contract research organisation.

For commercial trials, sponsors (or the contract research organisation) are required to provide the relevant Medicines Australia Form of Indemnity for Clinical Trials.

Contacts

Researchers or staff within WA Health who have questions in relation to clinical trial agreements or indemnity forms should contact the relevant person at their institutional research office as below.

Fremantle, Armadale or Bentley Hospitals, Rockingham or Kwinana Health Services
Wendy Khoo
Ethics Coordinator
Phone: (08) 9431 2929
Email: wendy.khoo@health.wa.gov.au

Sir Charles Gairdner Hospital
Nola Mammat
Research Governance Unit
Phone: (08) 9346 3153
Email: nola.mammat@health.wa.gov.au

Royal Perth Hospital
Katherine Coltrona
Business Development Manager, Clinical Trials Business Unit
Phone: (08) 9224 2260
Email:  katherine.coltrona@health.wa.gov.au

If the issues relate to more than one site or are of particular significance it may be helpful to contact
Don Black
Principal Policy Adviser
Legal and Legislative Services, Department of Health
189 Royal Street, East Perth 6004
Email: don.black@health.wa.gov.au