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. The SP-INV is responsible for the development of a robust study budget guaranteeing adequate finances from start to finish.


Main costs include:


In the event of a multicentre study, costs will increase according to the number of patriating study sites.


The SP-INV must guarantee adequate finances throughout the study. Thus, ongoing financial vigilance and oversight must be maintained from start to finish.

Payment to study participants:

  • Methods, amounts, source, and payment schedule are explained in the ICF, including any other written participant information
  • Payments are prorated and not given as a lump sum upon study completion
  • In order to avoid that study participant are subjected to coercion or undue influence, the EC reviews and approves both payment amount and methods

What do I need to do?

As a SP-INV, plan your study budget according to the scope of your study. The study protocol is a good basis for an assessment of expected study costs.


Consider costs related to:

  • Study-site costs: salary of local study staff, required infrastructure
  • Outsourced services: hiring of partners such as a project-manager, monitor, study coordinator or study nurse, statistician, data-manager
  • Service costs: such as laboratory services, storage (e.g. IMP/IMD, biological material), publishing, and archiving services that can incur over many years
  • Administrative costs: secretarial work (e.g. managing of participant visit schedules / staff meetings, management of study finances, ongoing document management)
  • Multicentre studies: decide in collaboration with the Site-INV costs needed for the successful implementation of the study at the study site


Use the study protocol as a basis for any financial agreement between involved service providers and participating study sites, and write up applicable partner contracts.


n order to maintain ongoing financial oversight:

  • Set-up a separate study account and define applicable payment plans
  • Assign a trained staff member to oversee and manage study finances
  • Document and regularly monitor all in- and outgoing transactions


Financial tracking will allow for financial shortages to be recognized early on, enabling applicable countermeasures.

Where can I get help?

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

External Links

Swissethics – see in particular

  • Insurance template
  • Clinical study agreement template


ICH GCP E6(R2) – see in particular guidelines

  • 1.17 Contract definition
  • 5.8.1 Insurance
  • 5.8.2-3. Subject compensation
  • 5.9.; 4.9.6. Financial agreement
  • 6.14 Financing and Insurance


ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections

  • 6.9 Agreements
  • 8.3 Outsourcing

Swiss Law

HRA – see in particular article

  • Art. 14 Non-remunerative participation
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • EC - Ethics Committee
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • IMP/IMD – Investigational Medicinal Product / Investigational Medical Device
  • INV – Investigator
  • ISO – International Organization for Standardization
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ 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): Development ↦ Management ↦ Study Management ↦ Budget

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