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 |