Budget negotiation - NALHN research projects

A Research Budget Template is available on request from the Research Governance Office (RGO) via e-mail.

Determining the Study Budget:

The following steps are designed for a Clinical Trial but are a good guideline for budgeting all studies. The Business Manager/Trials Manager should be consulted, however the following steps will help you with preparing your budget:

  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 fulfil the procedures listed in the protocol and make contact to obtain costing.
  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)

  5. Per Participant Budget. Add all identified procedures to your budget and calculate amount per visit/procedure (by estimating the labour time and apply overhead)

  6. Add Site Costs

  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 How to Apply and CTRA Requirements)

  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.