Clinical Trial Research Contracts & Budgets
1. Budgets and Financial Management
The purpose of this section is to assist new Clinical Trial Researchers, or experienced Clinical Trial Researchers who do not routinely negotiate Clinical Trial Research budgets or manage trial finances with a Quick Reference of these considerations for any Clinical Trial Research project.
This section covers the following components of Clinical Trial Research finances:
2. Standard Fees for Clinical Trial Research
A key component of setting up a clinical trial is to ensure budgets are developed and reviewed with the actual costs and resources required to conduct the trial. Below is a list of standard fees for some common areas that conduct and support clinical trials.
Please note the fees listed are the minimum fees that should be included in your budget for a study and the inclusion of the fee does not replace the need for each supporting department to review the protocol and area specific manuals to determine if additional or higher fees apply to your project.
2.1 Research Agreements and Fees
2.2 Pharmacy Fees
View Barwon Health Standard Pharmacy Fees here.
2.3 Barwon Medical Imaging (BMI) Fees
View Barwon Medical Imaging - Trial Billing Guidelines here.
In the interest of reducing legal review and building efficiency into clinical trial start up timelines, in 2007 Medicines Australia developed standard Clinical Trial Research Agreement (CTRA) templates for use in clinical trials.
Five templates have been developed to cover the varied nature of clinical trials relationships that cover both commercially sponsored and collaborative research trials. A full list of these can be found on the Medicines Australia website.
There are instances where commercial sponsors include specific clauses in Schedule 4 or Schedule 7 of the agreements. To address these requests, the South Eastern Border States (SEBS) Committee, was developed to review and approve sponsor specific amendments in the schedule. To date, most companies that require this already have SEBS approval for their specific clauses, however, please ensure a notification of the SEBS approval is provided to you and include this as part of your Governance submission. Further advice regarding the CTRA that is most appropriate for your trial can be obtained from the Research Development Unit (RDU).
You can also find more information on the agreements page of the RDU webpage here.
Last Modified: Monday, 26 June 2023