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:

  • Required insurance
  • Fees for EC/RA submission
  • Required infrastructure
  • Required staff and/or training of current staff
  • Partner collaborations (e.g. monitoring, statistics, data-, project management)
  • Participant compensation (based on the law)
  • Physician salary
  • Cost per study visit including laboratory analysis and other applicable activities

In the event of a multicentre study costs will have to be adapted accordingly.

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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 should be explained in the ICF, including any other written participant information.
  • Payments should be prorated and not wholly allotted upon study completion.
  • EC reviews and approves both payment amount and method, to assure that neither represents a problem of coercion or undue influence on study participants.

What do I need to do?

The budget will depend on study scope.

  • As a SP-INV of a multicentre study you will be responsible for all parts of the budget
  • In a multicentre study the Site-INV will negotiate with the SP-INV of the study regarding costs needed for study start-up, patient enrolment, and study closure.

For more information refer to Feasibility in this Study Guide.

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The study protocol may serve as a basis for any financial agreement between involved parties.

Write up applicable partner contracts in an agreement addressing financial compensation including payment mode.

Payment details to trial participants:

  • Must be approved by EC
  • Are documented in the ICF
  • Should be specified and paid out to participants during study conduct

In order to maintain ongoing financial oversight:

  • Set-up a separate study account and define payment plan
  • Assign a trained staff member to oversee and manage study finances
  • Document and regularly monitor all in- and outgoing transactions
  • Financial tracking will allow 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 - see in particular sections (access liable to cost)

  • 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/RA - Ethics Committee / Regulatory Authorities
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ICH-GCP – International Council for Harmonisation - Good Clinical Practice
  • INV – Investigator
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Development ↦ Management ↦ Study Management ↦ 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): Development ↦ Management ↦ Study Management ↦ Budget

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