| Melbourne Health Shared Pathology Service Fees for Clinical Trials |

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Effective 1st January 2009
Protocol review and preparation of Statement of Approval for ethics submission
The protocol review fee is a fixed cost regardless of whether the trial is approved by the HREC. This fee is to prepare the Statement of Approval for your HREC submission and includes reading the protocol, liaising with the relevant department heads/pathologists, Principal and senior scientists to ensure compliance with the trial protocol, coordination with investigators and/or meeting with representatives from the pharmaceutical company and assessing the costs.
| a) Standard Trials |
$310.00 | (with sponsorship by a pharmaceutical company/commercial /other organisation)
| b) Non standard trials |
$155.00 |
(partial or no sponsorship; investigator driven)
Establishment Fee
The Establishment Fee is a fee based on the complexity and size of the study. This fee covers costs associated with setting up the study including, but not restricted to preparing trial specific request forms, instructions and storage for samples to be dispatched to external central laboratories, method development, documentation and/or IT/data management.
| a) Standard Trials |
$500.00 |
| b) Non standard Trials (partial or no sponsorship) |
$250.00 |
Test Fee
The test fee is the cost for each test as shown on the Statement of Approval Form. This fee applies on a per test basis for each study subject. The fee is dependent upon the nature and complexity of the pathology test/s required. Please note that any tests requested in addition to those approved, will be charged to the trial
The test fee is based on the current Medicare Benefits Schedule (100% of current rates) for rebatable items. For non-Medicare items, the fees have been determined by the Melbourne Health Shared Pathology Service. These non-Medicare items may include preparation of tumour tissue blocks and slides, subculturing of isolates and the processing, storage and/or dispatch of specimens for external parties, All fees are subject to change based on yearly reviews.
Payment of Fees
Payment of the protocol review and establishment fees will be due on approval and commencement of the clinical trial/project. The total test fees for all subjects will be billed monthly or as agreed between the parties.
Contact Details
Clinical Trials Coordinator, The Royal Melbourne Hospital
| Telephone: |
03 9342 8000 |
03 9342 8935 | |