What is it? Why is it important?

The study budget represents the total sum of money needed to guarantee for the successful set-up, conduct and completion of a study.

Circumstances that might affect the budget during study conduct are:

  • Unforeseen events that increase costs (e.g. protocol amendments, recruitment of additional study sites, need for additional participants)
  • Slow recruitment rate with extended period needed for study conduct coupled with grant providers having restricted funding based on a given timeline (e.g. only for 2 years)
  • Staff fluctuations requiring additional study trainings

What do I need to do?

Check study budget on an ongoing basis to ensure expenses remain within acceptable limits. Plan ahead and if required be prepared to ask for additional funding

The SP-INV must guarantee and is responsible to maintain adequate finances throughout study conduct and completion. Thus, ongoing financial vigilance and oversight must be maintained from start until study completion.

For more information refer to Feasibility in this Study Guide.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

Abbreviations
  • CTU – Clinical Trials Unit
  • SP-INV – Sponsor-Investigator
Conduct ↦ Management ↦ Responsibility and Oversight ↦ Budget
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Management ↦ Responsibility and Oversight ↦ Budget

Please note: the Easy-GCS tool is currently under construction.