All research projects require a budget that is accurate (best estimate), transparent and justifiable.  The following budget guidelines and templates can be used to negotiate funding, obtain financial authorisation from the NALHN Business Consultant and complete the RGO SSA submission.

Budget Negotiation

Determining the Study Budget:

The Research Budget Template referenced below is available on request from the RGO: HealthNALHNRgo@sa.gov.au

  1. Review procedures / participant visits (protocol schedule of assessments). Checking if there are any additional assessments required as part of the inclusion/exclusion criteria, lab manual & radiology manual etc. or as a result of an expected/known Adverse Event.
  2. Determine above standard care procedures and establish which Supporting Departments will be required to fulfill the procedures listed in the protocol and make contact to obtain costing.
    • Research Budget Template: Supporting Departments Worksheet (request from RGO)
  3. Identify rates for salary based procedures using the following tools:
  4. Calculate Salary for Investigator time, Clinical Research Coordinator time, (on costs & overhead if applicable)
    • Research Budget Template: Salary Calculator Worksheet (request from RGO)
  5. Per Participant Budget (add all identified procedures to the Research Budget Template) and calculate amount per visit/procedure) by estimating the labour time and apply overhead
    • Research Budget Template: Per Participant Budget Worksheet (request from RGO)
  6. Add Site Costs
    • Research Budget Template: Site Costs Worksheet (request from RGO)
  7. Add Supporting Department Costs by using the following tools and contacting the impacted Department for quote
  8. Request the sponsor’s budget; cross reference the budget with the Schedule of Assessments in the Protocol ensuring to check all footnotes (e.g. the number of assessments for each visit can vary depending on the visit i.e. ECGs or PK collection time points).  Compare it with your site budget and negotiate.
  9. Once the budget is agreed and negotiated it can be transposed into the CTRA by the Sponsor.  Request and review the draft CTRA and addition of site details (see CTRA Requirements: http://www.basilhetzelinstitute.com.au/research/information-for-researchers/nalhn/complete-governance-application/)
  10. Submit the draft CTRA to the RGO for pre-review and,
  11. Schedule a meeting with the Business Consultant to discuss the negotiated budget, ensuring that you can demonstrate cost recovery to obtain financial authorisation.
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Obtaining Financial Oversight on the SSA

It is an SA Health requirement that all researchers obtain approval for their project’s budget from the LHN Business Consultant – if they are:
a) planning to undertake a research project at SA Health; or
b) planning to utilise SA Health resources to undertake a research project

A budget review is required to ensure approval of your Governance submission. The budget review process demonstrates to the RGO:
 the financial viability of each project; and
 ensures all charges associated with the project have been appropriately approved.

Please make a time to see the Business Consultant aligned to the Principal Investigator to discuss the study budget and cost allocations.

You should take the following documents with you to your meeting with the Business Consultant.
 A draft version of the CTRA  and your study Budget (labour time, project expenses reflecting the cost of running the study at this site)
 Project protocol (including what protocol specific procedures are above standard of care in NALHN as determined by the PI)
 Statement of support or approval from each Head of Department to be used to conduct the study and their costs (if applicable)
 SA Health Cost Centre number
 Expected number of participants

Questions that will need to be answered in the budget review process are:
 What resources will SA Health have to contribute to conduct the project?
 How will the cost of these resources be funded?

The Business Consultant will sign your SSA or the SSA Attachment: Financial Oversight Form if you have completed this form before the SSA.

Once authorised by the Business Consultant the Sponsor can proceed to execute the agreement and provide  the partially executed agreements (x 3 originals) for inclusion in your SSA Submission.

Please Note: Studies that are undertaken as part of normal research hours with internal departmental costing (i.e. wages) of less than $10,000 generally do not require Business sign off within NALHN. Studies with any external funding require sign off regardless of value.

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Impacted Departments & Service Agreement Forms

If your study involves above standard care assessments/procedures or requires services of another department you need to gain authorisation from the Head of Unit and provide evidence of support to the Business Consultant and RGO including the amount of any costs agreed.  The following forms and templates are available to request quotes for services and negotiate interdepartmental agreements.

SA Pathology:

SA Medical Imaging:
LMH – Medical Imaging Trial Approval Procedure

SA Pharmacy:

To request the current fees for your project contact Jacinta Nagle on 08 8282 1674 or  Health.LMHClinicalTrialsPharmacy@sa.gov.au 

Other Impacted Departments:

To request quote for services from impacted/supporting Departments that do not have their own agreement template or quote form, the following form can be used to request support/costs from the Department and attached to the SSA in lieu of signing the SSA.

 

 

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Return to Research at NALHN