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 | Â | Â | Â | Â | ++ |
Regulatory and ethics review | + | Â | Â | Â | ++ |
Monitoring | + | + | + | + | +++ |
Quality assurance | Â | Â | Â | Â | Â |
Trial master file handling & administration | + | + | Â | Â | + |
Safety | Â | Â | + | Â | Â |
Data management | Â | + | + | Â | Â |
Statistics, report and publication | Â | Â | Â | Â | Â |
Project management | + | +++ | Â | Â | ++ |
Patient and public involvement | Â | + | Â | Â | Â |
Intervention (medication/device) handling | Â | + | + | + | + |
Site costs | Â | Â | +++ | + | + |
External vendors/contractors/central review | Â | Â | Â | Â | Â |