| Application for Approval of Pathology Services for Clinical Trials, Research and Quality Assurance Projects |
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1. Principal Investigators (PI) for all clinical trials, research and QA projects using local pathology services must complete an Application for Pathology Approval using the following forms:
Submit it to the Clinical Trials Coordinator in Pathology.
2. A signed Statement of Approval form, required as part of your HREC submission, will be issued. Please allow at least two weeks for approval to be finalised.
3. Clinical trials requiring pathology tests deemed to be standard patient care for that particular group of participants must also be submitted for review and approval.
4. Approval, establishment and ‘per test’ fees apply. Refer to Service Fees.
5. The costs and conditions of approval to use the services of the MHSPS are based on the information provided at the time of request. These may be affected by amended or additional testing requirements, significant increases in the number of subjects enrolled, changes to approval, establishment and CMBS (Commonwealth Medical Benefits Schedule), non-CMBS test fees or secondary providers’ test fees
6. Any protocol amendments affecting pathology services, need to be communicated to MHSPS
7. Non-trial related services provided to Western and Sunshine hospitals are charged to the relevant unit as part of the financial arrangements in place between Melbourne Health and Western Health
8. Trial-specific pathology request forms will be provided for your trial and are to be used for all trial related testing. These customised request forms help identify and track the specimens for correct handling, reporting and billing purposes.
9. To avoid being billed for tests that are part of routine care:
§ separate specimens are to be drawn for trial and standard care tests and are to be sent to pathology with separate request forms.
§ the request form for standard care testing will have the patient’s regular financial class. It is important that these requests do not include the HREC number or they will be charged to the trial
§ do not handwrite additional tests on the trial specific request forms. Any handwritten tests will be charged to the trial
10. Where special handling of specimens is required, lab procedures must be in place before the trial can commence.
11. If MHSPS does not provide a specific test or where a test is not routinely referred to an external laboratory, the requesting PI may negotiate an arrangement with a secondary provider. Specimens will be processed through MHSPS. Specific inquiries need to be made.
12. Billing occurs monthly - via journal for RMH cost centres or invoice raised to the nominated debtor. GST applies to all externally held accounts. The PI is responsible for ensuring adequate funds are available to pay for services provided.
13. The Clinical Trials Coordinator for Pathology should be contacted upon completion of the trial.
14. By signing of the Form 6 Statement of Approval form you have agreed to these terms/conditions.
Contact: Clinical Trials Coordinator
Melbourne Health Shared Pathology Service on 9342 8000 | 
