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 |