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Table 2 Simplified example based on the use of the budget tool (version 4.0)

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

Project design and set-up€84,825
 - Development of budget and study protocol (including amendments, consent form and any questionnaires), risk assessment and management plan, contracting with funder and vendors, initial selection of sites/GPs
 - On-site feasibility check (per site, for 50% of the sites)
 - Remote feasibility check (for other sites)
 - Negotiation of site agreements
 - Subcontracting with tender
Regulatory authorities, ethics committees, insurance€29,835
 - Submission to the leading ethics committee
 - Submission to the ethics committees of participating sites
 - Communication with ethics committee per study year
 - Submission to regulatory authorities
 - Communication with regulatory authorities per study year
Study monitoring€266,079
 - Development of a monitoring plan, risk-based
 - Study monitor familiarisation with trial
 - On-site initiation visit, monitoring visits, closure visit
 - Fixed average transportation fee per on-site visit
 - Remote monitoring visits
Quality assurance€7020
 - Sponsor audit on site 2 days by independent auditor; includes visit, preparation and report
Trial master file (TMF) & administration€66,234
 - Set-up of (electronic) TMF
 - Set-up of investigator files, 4 h of clinical trial assistant per site
 - Maintaining files, 12 h of clinical trial assistant per site per year
 - Sponsor making payments to the sites, 1 per site per year
 - Archiving, 2 large boxes plus 1 per 4 sites for 25 years
Safety monitoring and expedited reporting€14,040
 - SUSAR documentation and expedited reporting
 - Data safety monitoring board (DSMB) meeting (1x/year)
Data management€141,570
 - Data management plan, database and electronic case report form (eCRF) set-up for comparative effectiveness trial
 - Import, validation, coding, query management per patient (2 h per patient)
Statistics, report and publication€58,500
 - Statistical analysis plan, randomisation plan, programming
 - Statistical analysis and clinical study report
 - Publication, including open access fee
Project management€367,497
 - Trial management group meeting (2x/month until end of recruitment, monthly thereafter)
 - Trial steering committee meeting (3x/year during first year, then 2x/year)
 - Investigators meeting, at study start and end
 - Project manager time per year: 0.2 full-time equivalent (FTE) + 0.025 FTE per site
Patient and public involvement€6552
 - Participation during study design and set-up phase
 - Participation of 2 representatives in steering committee meeting
Study intervention/investigational medicinal product (IMP) handling€152,340
 - Purchase of intervention/IMP/placebo, blinding, packaging, labelling, recovery and destruction of unused product
 - Storage and distribution
 - Central randomisation system and unblinding if applicable
Site costs€518,310
 - Start-up fee
 - Per patient visit 2 h study nurse and 10 min clinician time + 30 min clinician time at first visit
 - Lab sample whole blood at 5 visits for central lab
 - Local pharmacy costs for transfer study
 - Archiving box for 25 years
External vendors€0
 - Study-specific equipment or external services are already included in the IMP budget
TOTAL BUDGET without value-added tax (VAT)€1,725,672
TOTAL BUDGET with 21% VAT€2,088,063
  1. To calculate the budget for this study, we took into account the following study parameters: 20 sites, 400 patients, 7 visits per patient, recruitment period of 18 months, treatment period of 24 months, total study duration of 4 years, 5 on-site monitoring visits and every 2 months a remote monitoring visit, 3rd party placebo development, packaging, labelling, distribution