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Frequently Asked Questions (FAQ) - (Unit) Costs / Budget
Your suggested project has to fully respond to the call text, i.e. reach the objectives and bring about the expected impacts listed in the work programme by the end of the project duration. If the project you are suggesting builds on results that are funded otherwise, that is a good thing. It has to be ensured though that the other periods are either already completed, or that funding is already secured – otherwise, reviewers may see this as too high a risk.
In all types of Clinical Studies or even in EU funded Projects in general, only those costs incurring during the running project will be reimbursed by the Commission. So all costs that incurred before the start of the project will not be reimbursed.
Fees for ethical committees will be other direct costs. Insurance costs can be part of the unit costs or other direct costs (when choosing actual costs).
Funding of Phase 3 or Phase 4 Trials depends on the topic. Some topics might even require later phases of trials as well. Generally, it is possible to claim partial costs. Just make sure to explain how you will cover the remaining costs that won’t be requested from the EC, so it will be clear to the reviewers that you will be able to conduct the CT properly. If you will apply only for partial costs of the study in the scope of the EU project, e.g. for certain study sites but will cover other sites by yourself, you will have to convince the reviewers that data of those sites not included in your project will still be obtained to ensure the feasibility of your project.
Yes, costs of insurance can be part of the unit costs.
Yes, please see page 5 of the template. It states: Costs incurred in another currency shall be converted into Euro at the average of the daily exchange rates published in the C series of the Official Journal of the European Union, determined over the corresponding year N-1. If no daily Euro exchange rate is published in the Official Journal of the European Union for the currency in question, conversion shall be made at the average of the monthly accounting rates established by the Commisson and published on their website.
Inclusion of ‘regular’ CROs as beneficiaries is also possible (in that case: full partners, i.e. involved from the planning phase on and active partners in study design). But some CROs that work on a 'for profit' basis might not be willing to become a beneficiary, in these cases, subcontracting could be an option. BUT only limited part of the action can be subcontracted.
Depends on the topic. They also fund observational studies, if there is a respective topic for that.
Yes that is correct. Each beneficiary can decide to be reimbursed on basis of unit costs or actual costs for a given clinical study.
For unit costs, the EC foresees different cost levels for different beneficiaries (see table in the template you are referring to column 3 & 4 + example provided in the table). While the total amount per unit can vary between beneficiaries of a consortium, the estimated effort (e.g. time of a doctor spent per unit & amount of resources used per unit) must be the same for one trial, study investigation.
Costs for hospital care that are paid through the national healthcare system/covered by health insurance cannot be charge to the project. Any costs for managing the patient that incur only due to the implementation of your project can be listed in the project budget.
You would have to estimate as good as you can, based on information that is available and that has been recorded in the past. For example, even if that specific clinical trial has not been implemented at your site yet, you should be able to estimate the amount of time that your staff will spend per patient, and use the personnel costs from the last recorded year to calculate the personnel cost per patient included in this new study. All other components, such as consumables etc., should be calculated similarly.
As this system is completely new, we have no information as to how the evaluators are briefed. Nevertheless, the calculation of unit costs must be based on recorded & certified figures and the methodology of calculation can be audited in the CFS / by the EC.
Unit costs that are usually used by hospitals may be a very good option for estimates on some components of your unit costs per patient, yes. Please note that costs which are paid for by the national health system cannot be charged to the project though. The calculation of the unit costs (see table in template for clinical studies) will become part of the Grant Agreement (Annex II). The methodology applied in order to calculate unit costs will thus be auditable in the frame of a CFS or an official audit by the EC. The number of actual units claimed during the action must comply with the following conditions:
- the units must be actually used during the project
- they must be necessary for implementing the action & identifiable and verifiable, in particular supported by records and documentation.
For PHC 14 (rare diseases) you are advised to contact EMA very early in the process. This is: before submitting stage 2 you MUST HAVE received orphan drug designation, so start contacting EMA today! http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen... http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen...
Study medication I personally would put under "other direct costs", but NOT to use in the "unit costs per patient". With the study medication, you have some more steps to get funded: packaging, blinding/ coding, maybe even (GMP) manufacturing. Overall, I would put it as bigger tasks than just as "consumables".
No ballpark figure, no. Numbers must be based on actual costs recorded in last closed accounts of beneficiary, described in detail in the full proposal, and will be assessed by the evaluators.
Any costs that will be reimbursed by health care providers/ insurance are NOT eligible for funding via the EU project.
Unit costs are partner specific - i.e. you will most likely have different unit costs for each partner.
Yes - they would have to be defined for that linked third party specifically in any case.
The use of unit costs is a decision that can be made project by project, i.e. one institution can use unit costs in one project and actual costs in another project.
Yes, this is true. Unit costs per patients have to be used for ALL patients of a beneficiary, for ONE CT. For a second CT, a second template will be filled-in (make sure to upload in ONE document).
It is possible to include study centres as 3rd parties providing in-kind contributions against payment. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Please also see question 8 under “Consortium / Partners / Third Parties”.