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.
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, you will have various study costs such as hiring a project-manager, monitor, study coordinator, statistician, data-manager, including storage-, publishing-, archiving-costs.
- 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.
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
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
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 - see in particular sections (access liable to cost)
- 6.9 Agreements
- 8.3 Outsourcing
HRA – see in particular article
- Art. 14. Non-remunerative participation