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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 budget

Main cost drivers of study budget

Recruitment period (FPI to LPI)

Study period (FPI to CSR)

No. of patients

No. of study visits

No. 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