What is it? Why is it important?

The study budget represents the total sum of money needed to guarantee 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 depending on the number of participating study sites.

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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
  • To ensure study participants are not 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:

 

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

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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

References

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
Abbreviations
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Management ↦ Study Management ↦ Budget

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