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 study insurance
- Fees for Ethics Committee (EC) regulatory (e.g. Swissmedic, international) submission and approval
- Required infrastructure
- Required qualified study staff and study relevant trainings
- Oursourced services / Partner collaborations (e.g. monitoring, statistics, data manager, project management)
- Participant compensation (according to the law)
- Physician salary
- Cost per study visit including laboratory analysis and other applicable activities
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.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 (access liable to cost) - see in particular sections
- 6.9 Agreements
- 8.3 Outsourcing
HRA – see in particular article
- Art. 14 Non-remunerative participation