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, completion, and archiving of a study.


It approximates the probable cost based on:

  • Planned activities during the individual study phases from concept until completion
  • Requirement for additional expertise and outsourced services  (e.g. 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 Ethics Committee (EC). and if applicable regulatory submission (e.g. Swissmedic, International).

What do I need to do?

As a SP-INV, estimate your study budget and include aspects such as:

  • Study Staff: requirement and training (e.g. treating physician, project-/quality manager, study nurse, secretary, financial officer), which includes Quality control and Quality Assurance staff
  • Partners / Outsourced Services: database set-up, statistical support, IMP/MD production (placebo), monitoring, submission to EC and Swissmedic, study insurance
  • Infrastructure: work space, storage facilities, patient rooms
  • Equipment: freezers, computers, analytical/technical devices
  • Multicentre collaborations: the inclusion of additional study sites
  • Inspections: performed by regulatory authorities. An event that should be anticipated in category B and C studies


For outsourced services, contact respective partners and request a cost estimate. This will ensure that a realistic budget is submitted to grant providers.



When setting-up a study budget, assess aspects that address:

  • The study design, such as:
    • 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
  • Respective funds needed during study concept, set-up, conduct, and completion
  • Time needed to perform certain tasks (e.g. blood sampling, laboratory work, patient information and education)
  • Hourly wages based on study 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
  • Archiving costs

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


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
  • 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

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

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

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