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.

More

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 multicentre 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

References

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 – see in particular sections (access liable to costs)

  • 6.9 Agreement(s)
  • 9.3 Outsourcing of duties and functions
Abbreviations
  • CTU – Clinical Trials Unit
  • CRF – Case Report Form
  • EC – Ethics Committee
  • EC/RA - Ethics Committee / Regulatory Authorities
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/MD – Investigational Medicinal Product / Medical Device
  • ISO – International Organization for Standardization
  • RA – Regulatory Authorities
  • SP-INV – Sponsor-Investigator
Concept ↦ Management ↦ Resources ↦ Budget
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Concept ↦ Management ↦ Resources ↦ Budget

Please note: the Easy-GCS tool is currently under construction.