Your Easy Guide to Clinical Studies

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

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.