Development↦Management↦Study Management↦Budget
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:
- Mandatory study insurance
- Ethics Committee (EC) and if applicable regulatory fees (e.g. Swissmedic, international)
- Required infrastructure
- Qualified study staff including training (e.g. GCP)
- Oursourced services / Partner collaborations (e.g. monitoring, statistics, data management, 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 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:
- Study-site costs: staff salary and required local 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. management and scheduling of study visits, staff meetings, study finances, ongoing document management)
- Multicentre studies: decide in collaboration with the Site-INV costs needed for the successful implementation of the study at each study site
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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
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