What is it? Why is it important?
The study budget represents the total sum of money needed to guarantee for the successful set-up, conduct and completion of a study.
It approximates the probable cost based on:
- Planned activities during the individual study phases from concept until completion
- Additional relevant information (e.g. requirement for additional partners)
- Required drugs and/or specific study material needed for study implementation (e.g. IMP/MD, analytical apparatus, laboratory kits)
A detailed budget overview should be finalised prior to submission to the EC and RA.
What do I need to do?
For your study, define requirements and costs with respect to:
- Staff: Project-/quality manager, study nurse, secretary, financial officer
- Services: database set-up, statistics, IMP/MD production (placebo) and handling, submission to EC/RA, study insurance
- Infrastructure: work space, storage facilities, patient rooms
- Equipment: freezers, computers, analytical/technical devices
- Partners: hospital internal and external including potential audits
- Quality control and Quality Assurance
- Multicentre collaborations: additional study sites including planned monitoring and patient fees
- Inspections: performed by regulatory authorities. An event that should be anticipated in category B and C studies, as they carry an increased risk.
For more information refer to Feasibility and Quality and Risk in this Study Guide.
When working out the study budget, evaluate and include expected costs with respect to:
- Study design:
- Methodology (e.g. randomized, blinded, parallel trial)
- Planned patient number
- Planned overall study duration
- No. of collected data variables
- No. of patient visits including follow-ups
- Study treatments (IMP/MD)
- Planned medical analysis
- Other types of analysis (e.g. laboratory, imaging)
- Collection of biological material
- Required safety reporting
- Funds needed during concept, set-up, conduct, and completion (e.g. staff trainings, publication costs)
- Time needed to perform certain tasks (e.g. blood sampling, laboratory work, patient information and education)
- Hourly wages based on task and role
- Funds needed to cover SP-INV responsibilities (e.g. project manager, monitor, auditor, data manager, statistician, submission, insurance, electronic devices, equipment, IMP/MD, infrastructure, inspections by regulatory authorities)
- Funds for multi-centre studies (e.g. individual site costs including patient fees)
- Publication costs
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH-GCP E6(R2) – in particular see guidelines
- 4.5.1 Site contract
- 4.9.6 Financial agreement
- 5.9 Financing
ISO 14155:2020 Medical Devices (access liable to costs) – see in particular sections
- 6.9 Agreement(s)
- 9.3 Outsourcing of duties and functions