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Table 1 Influence of main cost drivers on the study budget

From: Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency

Sections in study budgetMain cost drivers of study budget
Recruitment period (FPI to LPI)Study period (FPI to CSR)No. of patientsNo. of study visitsNo. of sites
Project design and set-up    ++
Regulatory and ethics review+   ++
Monitoring+++++++
Quality assurance     
Trial master file handling & administration++  +
Safety  +  
Data management ++  
Statistics, report and publication     
Project management++++  ++
Patient and public involvement +   
Intervention (medication/device) handling ++++
Site costs  +++++
External vendors/contractors/central review     
  1. + low impact, ++ moderate impact, +++ high impact