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Frequently Asked Questions (FAQ)
The template 'Essential information to be provided for clinical trials…’ mentions Horizon 2020 single-stage and stage-2 topics for which it is mandatory to complete the template. For respective topics you will have the possibility to upload the completed template as a separate part of your application in the submission system. For all other topics - if a proposal contains a clinical study - you are welcome (but not obliged) to use the structure provided in the template (or an adapted version) and integrate this information in section 1.3 (‘Concept and approach’) or in the relevant work package in section 3.1 (‘Work plan – Work packages, deliverables and milestones’) of part B of the proposal. If required, the table provided in section 1.9 of this template on unit costs can in this case be provided in section 3.4 (‘Resources to be committed’) of part B of the proposal.
In a first step categorize the personnel available within your institution into the three personnel categories (doctors, other medical personnel, technical personnel). There is no fixed rule which personnel are to be allocated to which category. The category ‘technical personnel’ is to be understood as a broad category. However, the information given in the employment contract should be in line with the category the personnel are aligned to. The assignment of the personnel to the three categories should be the same for all subsequent applications which will provide a sound basis of personnel allocation to the three categories for the auditor.
The understanding of ethical concerns should clearly emerge from the proposal. Please check which ethics issues in the ethics issues table (part A/proposal submission form) apply for the activities envisaged in your proposal. The information that needs to be provided in proposal section 5.1 (part B) depends on the ethics issues ticked. The EC guide ‘How to complete your ethics self-assessment’ will exactly guide you through the points to be discussed in proposal section 5.1 for each ethics issue.
For each Horizon 2020 clinical study, three mandatory deliverables (Annex 2 of the template 'Essential information to be provided for clinical trials…’) have to be included in the proposal, whereby the first mandatory deliverable (due prior to enrolment of first study subject) requests a final version of the study protocol. Mandatory deliverables:
1. 'First study subject approvals package' (prior to enrolment of first study subject):
a. Final version of the study protocol
b. Registration number of clinical study
c. Regulatory and/or ethics approvals
2. 'Midterm recruitment report‘ (to be scheduled for the time point when 50% of the study population is expected to have been recruited)
3. 'Report on status of posting results' in the study registry(s) (to be scheduled for the time of expected results posting or for the last months of the project, whichever comes earlier)
Information on the method for calculation unit costs is available in the template 'Essential information to be provided for clinical trials…’ (section 1.9 ‘Unit costs per patient for clinical trials / studies / investigation’ and Annex 1 ‘Method to determine the unit costs’). The template itself is available in the Participant Portal for relevant topics under 'Call Documents'.
Each section of the clinical trial template must be shortly and concisely described. Information outside the scope of this template will not be taken in account for the proposal evaluation. No other chapters or annexes (containing e.g. complete study protocols) can be added to this template. Section headings should not be changed. In case one or more issues do not apply to a particular study, please briefly explain/ justify. Information provided in this template does not need to be repeated elsewhere in the proposal, but can be referred to.
When the requested information is currently not available (e.g. a clinical study is planned for a later stage of the project and will be based on data from prior studies) the source of required data should be provided and/or the selection of the applied methodology should be described.
The full proposal must be consistent with the short outline proposal and may not differ substantially. Changes are not recommended, but if absolutely necessary, they should be clearly explained in the Proposal submission form, section ‘Declarations on stage-2 changes’. The evaluators will determine whether or not these changes are legitimate, and whether or not their insertion compromises the evaluator judgement made at stage 1.
Beneficiaries must award a subcontract ensuring the best value for money and compliance with the institutional rules for subcontracting and – if the beneficiary is a public body – with national and EU legislation on public procurement.
Each beneficiary should budget its own costs. Costs should be budgeted in line with the project activities each partner is involved in.
In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization.
Timely completion of projects is a declared goal under Horizon 2020. There is no flexibility regarding duration – project extensions can generally not be granted in Horizon 2020. Non-compliance with expected timelines and recruitment estimates (significantly delayed key study milestones) might lead to reduced EU contribution or the termination of the grant agreement. Upcoming challenges must be reported quickly and fully to the EC officers in charge. Exceptional project extensions are based on a case-by-case decision by the European Commission.
Section 1.6 of the template ‘Essential information to be provided for proposals including clinical trials...’ requests concise information on safety and tolerability of study interventions: e.g. pre-clinical data from in vitro or in vivo studies; data from previous clinical studies; data from (pharmaco)vigilance systems or other sources. Furthermore provide concise information on efficacy of study interventions based on (pre-)clinical data.
Only limited part of the action can be subcontracted (Art. 13 MGA).
For subcontracting to CROs: If the clinical study is the main activity of the project, core study expertise cannot be subcontracted. However, certain parts (e.g. GMP manufacturing) might be subcontracted as long as general regulatory expertise is available and the study design, high-level study management and oversight remain as tasks within the consortium.
If the clinical study is just a small part of the project, i.e. most of the project is preclinical activity, the study might be subcontracted in its entirety.
The ESTIMATION OF RESOURCES (per task on the basis of the protocol) per clinical study subject is the same for all beneficiaries applying unit costs. However, each beneficiary calculates the costs based on its historical costs. Historical costs mean the costs from the last closed financial year at the time of submission of the proposal.
HORIZON 2020 also supports preclinical activities. The scope section of each topic clearly describes the expected activities. In order to clarify content-related questions please seek advice e.g. from your National Contact Point.
The combination of unit costs per patient and actual direct costs within one clinical study is possible. Exception: For the costs of personnel directly assigned to the conduct of a clinical study, each beneficiary or third party may only choose ONE OF THE FORMS (unit costs per patient or actual direct costs). However, this does not apply to personnel costs for horizontal tasks (e.g. study monitoring or coordination).
In Horizon 2020 third parties (i.e. parties not signing the Grant Agreement) receiving payment can be involved as a contractor for other goods and services (Art. 10 MGA), subcontractor (Art. 13 MGA) or as third parties providing in-kind contributions against payment (Art. 11 MGA). Patient data, for example, can be considered as in-kind contribution. A requirement for ‘in-kind contribution against payment’ is a written agreement between the beneficiary and the third party prior to the start of the work. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Wherever possible, third parties should be listed in section B4.2 of the full proposal.
Data Management (5)
Please see Guidelines on FAIR Data Management in Horizon 2020 (http://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/h...), section 4. ‘Research Data Management plans during the project life cycle’:
A funded project must submit a first version of its DMP (as a deliverable) within the first 6 months of the project. The DMP needs to be updated over the course of the project whenever significant changes arise, such as (but not limited to):
- new data
- changes in consortium policies (e.g. new innovation potential, decisions to file for a patent)
- changes in consortium composition and external factors (e.g. new consortium members joining or old members leaving)
As a minimum the DMP should be updated and detailed with each periodic report. Furthermore, the consortium can define a timetable for review in the DMP itself.
The DMP is intended to be a living document in which information can be made available in more detail through updates as the implementation of the project progresses and when significant changes occur.
If it is just safekeeping of actual data, any of the big IT companies will likely serve. In general there are (country specific) centers that are helpful or can serve as partners.
One approach is to also archive the software to access the data. That said raw data should be in a well described and documented format in such a form that at the very least one can access by reprogramming a tool in the worst case. Thus it is absolutely important to have good metadata and standards which describe standards. In such cases even new software versions can still access, work and use legacy formats (as an example microarray data from the late 90s are still accessible in 2017).
A DMP should be integrated into the WP (scientific or non-scientific) it fits best. Data management can be part of an already existing task or can form an own task, depending on the relevance of data management in your envisaged project.
Depending on (i) where the data is coming from, (ii) ‘data intensity’.
If the data is OpenData already and from a reliable provider (say data.gov.uk) it is probably fine to just cite this resources. In case of doubt one might want to at least (if copyright etc. allows this) capture the stream or the historical data and deposit this as a dataset. This is definitely possible for not too large data sizes. This has the added advantage, that the analysis based on such data could be reproduced with the exact same ‘primary data’ set. In such case it might thus be useful to archive the underlying data in either a catch all or discipline specific database.
Another case might be webservice that provide an analysis on your primary data or provide computational access to a large internal dataset. As such database might go away one might want to capture exact input and output. Some providers experiment with virtual machines and docker images now, which might be a future perspective for long term preservation.
Please proceed with getting documents ready once notification of the award is given by the EDCTP. With regard to the legal entity form – this form has been adapted and it needs to be filled in by all beneficiaries.
You can register via our website, and after an internal assessment you could be added to our pool of reviewers.
The signature of the accession form is due within 30 days from signature of the grant agreement.
No, consortia are formed by applicants without EDCTP involvement.
No, EDCTP uses a different list of experts, but some may be those listed on the EC Portal.
EDCTP Webinar (13)
Cofunding can be provided by either public or private legal entities from across the world, including the institution of the lead applicant. Please note however that one of the EDCTP objectives is to promote international research cooperation.
Funding from WHO can be considered as cofunding (additional funding on top of the EDCTP grant amount).
No, the term cofunding refers to funding for the project in addition to the requested EDCTP funding or awarded grant amount.
Cofunding is not required for projects for which EDCTP2 grants are sought (i.e. EDCTP will reimburse 100% of eligible costs) but it is encouraged. If an applicant has secured cofunding for the project, this can be documented at the proposal stage with letters of commitment from other funder(s).
Specifically for the current call 'Strategic actions supporting large-scale clinical trials', all organisations that provide cofunding should address an official letter to the Coordinator and these should be submitted by the Coordinator at the Letter of Intent application stage (the electronic form for this call for proposals allows for this). The letter of any cofunder should state the name and organisation of the Coordinator; the title of the EDCTP proposal and the EDCTP call to which the proposal has been submitted. In the Budget and Cofunding section of the application form, the applicant can provide an explanation with details on the committed funds, the timeframe for the commitment and any conditions or restrictions on the funding. Demonstration of major support from other funders at the level of the large-scale clinical trial will be taken into account during the evaluation of the “Impact” criterion.
Swiss legal entities are considered entities from a third country not associated to Horizon 2020. This means that Swiss legal entities can participate in EDCTP-funded projects but are not eligible to receive funding and will not count towards the minimum number of legal entities required for a proposal (see the specific eligibility criteria for each call for proposals).
For more information on funding by the Swiss government for Swiss participants in projects related to Horizon2020 or Article 185 Initiatives, please see: http://www.sbfi.admin.ch/h2020/index.html?lang=en.
There are no specific eligibility criteria in relation to a lead applicant other than the eligibility criteria specified in the call text. Please see the call text for specific requirements. Prior to signing the grant agreement, EDCTP will assess the capacity of the lead applicant’s institution to administer and manage the grant.
NID = Neglected Infectious Diseases, otherwise also known as Neglected Tropical Diseases.
The work plan for 2015 is currently being reviewed by the European Commission and EDCTP expects a decision no earlier than September 2015.
Third-party involvement can be mentioned in the body of the application but currently there are no specific fields requesting this information.
All technical questions regarding the application form should be addressed to email@example.com directly, and for specific questions on the different types of participants to be added in a proposal, please contact the Project Officer (see name and e-mail in the Call Text) in charge of the Call.
It is correct that in case of applications in two stages, at the Letter of Intent stage there is no requirement to include figures, charts or other graphics in submitted proposals. In the Letter of Intent stage of this call, the only criteria that are used for the evaluation of the proposals are Excellence and Impact.
EDCTP aims to keep the Letter of Intent stage as simple as possible. At the second - full proposal – stage, the quality and efficiency of the implementation in addition to the Excellence and Impact criteria are evaluated. The application form will be equipped with upload functions where applicants can upload supporting documents such as charts.
In general, if attachments are required for a specific section of the Letter of Intent or the full proposal, the form will have the necessary upload function, e.g. for the call 'Strategic actions supporting large-scale clinical trials', cofunding letters can be uploaded and attached to the Letter of Intent.
Pre-clinical development cannot be supported by EDCTP. EDCTP only supports phase I to IV clinical trials. The grant that EDCTP provides, in case a proposal is successful, can be used in part to cover the costs associated with manufacturing a product that is necessary to conduct the clinical trial (phase I and beyond), on the condition that accounting conditions for recognising expenditures are met.
Under no circumstances can any (manufacturing) cost incurred before the start of the EDCTP-funded project, be counted as cofunding to the project (in case cofunding is requested). Requests for funding of early pre-clinical work can, for example, be directed to other Horizon2020 programmes.
The ‘Strategic actions’ call supports clinical research activities which are part of a large-scale clinical trial that has the potential to achieve rapid advances in the clinical development of new or improved medical interventions against poverty-related and neglected infectious diseases. In short, the ‘Strategic actions’ call focuses on large-scale clinical trials. The ‘Diagnostics’ call is intended to fund projects that aim to validate the clinical performance and/or implementation of new or improved diagnostic tools and technologies for the detection of any of the PRDs (including as co-infections).
It can be considered if it is presented as comorbidity with a poverty-related infectious disease within the remit of the call.
EDCTP provides funding for research on infectious diseases, especially poverty-related and neglected and/or emergent infectious diseases prevalent in sub-Saharan Africa.
See AGA 4.0 p. 151:
The linked third parties may declare their costs (in their financial statements; see Article 20.3), if the eligibility conditions set out in Article 6.3 are fulfilled (e.g. actually incurred by the linked third party, necessary for the action, incurred during the action duration, etc.).
The costs must be recorded in the accounts of the linked third party.
- Linked third parties may declare costs for all cost categories (as provided for in Article 5), including indirect costs (at the 25% flat rate).
- Each linked third party declares its own costs. The costs of the linked third party must not be included in the beneficiary’s financial statements.
Each linked third party has its own financial statements, but these statements must be submitted by its beneficiary (since linked third parties cannot sign them in the IT system; see Article 20).
For this purpose, linked third parties must send their signed financial statements on paper to their beneficiary.
Yes. There should be no big deviations to the budget specified in the first stage. But you can make small corrections.
If you mean the second phase of the SME instrument: then yes. Otherwise: no.
You find the rules concerning in-house-consultants in the AGA 4.0 p. 72:
Direct personnel costs: Natural persons with direct contract (A.2)
1.2.1 What? This budget category covers typically the costs of in-house consultants and similar persons (i.e. self-employed natural persons) that worked on the action for the beneficiary under conditions similar to those of an employee, but under a contract which is NOT legally the same as for employees. It regards, in particular, contracts qualified as quasi-subordinate work contracts under national law when the conditions under which the work is carried out are similar to those of an employee.
No. The only costs eligible before project start are travel costs to the kick-of-meeting IF the travel itself took part within the project duration.
In the periodic report you have to report the work carried out – not what you had planned to do. So yes, you have to at least communicate it within the periodic report. Also it never hurts to let your project officer know what you are doing.
Yes. You have to depreciate according to the rules applicable for your company.
Yes. This is however not the case if you have personnel working 100% on the action. In that case you need to “sign a declaration on exclusive work for the action [ODT format] (one per reporting period), to confirm that the person worked exclusively for the action, either: during the whole reporting period or during an uninterrupted time-period, covering at least a full calendar month within the reporting period.” (see AGA 4.0 p.175)
If there are persons working part time; there is no special treatment compared to full time employees. For temporary workers see AGA 4.0 p.50: “Staff provided by a temporary work agency — A contract with a temporary work agency qualifies typically as a purchase of services (unless the temporary work agency carries out directly some task of the action — in which case it would be considered as subcontracting). Thus, although NOT eligible as personnel costs, the costs can be charged under other budget categories (i.e. D.3 other goods and services or B. subcontracting), if they comply with the eligibility conditions (e.g. best value for money and no conflict of interest; see Articles 10 and 13).”
“Unit costs” are a special type of costs. You can find the definition in Article 5.2. Regarding personnel costs you can use the “unit costs” in very few special cases:
“Personnel costs for SME owners or beneficiaries that are natural persons not receiving a salary (see Article 6.2, Points A.4 and A.5) must be declared on the basis of the amount per unit set out in Annex 2a (unit costs)”
Third Parties (32)
The answer can be found in the Annotated Model Grant Agreement (MGA) under Article 10 (Subcontracting, page 128) and Article 13 (Contracts to purchase goods, works or services, page 119). There is also a table comparing those two options (Article 8 pp 113).
Since the price is charged by a different department of the same legal entity, this is considered internal invoicing.
The beneficiaries must base their subcontracts on the ‘best value for money’ or on the lowest price. The best value for money principle does not require competitive selection procedures in all cases. However, if a beneficiary did not request several offers, it must demonstrate how best value for money was ensured.
No, contracting between beneficiaries is not allowed. Each beneficiary must declare its own costs.
The Grant Agreement does not exclude the possibility that a contract or subcontract is awarded to a third party with a legal link to a beneficiary (which is not an affiliate). However, the selection of the (sub-)contractor must not be influenced by a conflict of interest. See the examples in article 35 of the Annotated Grant Agreement for further information.
The rule is that the tasks to be implemented and the estimated cost for each subcontract must be set out in Annex 1, and the total estimated costs of subcontracting per beneficiary must be set out in Annex 2. The actual price may be higher or lower than the estimation in the budget. There is no ‘% tolerance’ foreseen.
We are afraid it is impossible to answer your question regarding contracts/subcontracts in general without knowing further details.
Regarding durable equipment such as machines, only the share of the depreciation costs used for the action (taking into account the equipment’s ‘full capacity’) is eligible.
By definition, a Linked Third Party does not charge a price, but declares its own costs in line with the eligibility conditions of the Grant Agreement. Therefore, a Linked Third Party cannot be a subcontractor of a beneficiary in the same project.
We are not sure if we understand your question correctly.
As a general rule, service contracts do not cover the implementation of an action task (as defined in Annex 1), but are necessary for the implementation of a task by beneficiaries themselves. As long as the analytical work performed does not cover the implementation of action tasks, it is considered a service and not a subcontract.
According to the Annotated Model Grant Agreement, ‘framework contract must (have) be(en) awarded on the basis of best-value-for-money and absence of conflict of interest.’ Moreover, general eligibility conditions such as compliance with the principles of sound financial management, apply. There is no rule that explicitly requires a re-evaluation of the framework contract after several years.
To a large extend, the distinction between contracts and subcontracts is project-specific. If the work to be outsourced is defined as an action task in Annex 1 of the Grant Agreement, the related contract is considered a subcontract. In contrast, a contract does not cover the implementation of an action task, but is necessary for the implementation of a task by beneficiaries themselves.
Implementing tasks as a Linked Third Party is an option, not an obligation. It is up to the potential Linked Third Party and to the consortium do decide if it makes use of this option or includes the organisation as an additional beneficiary. In general, entities performing a substantial part of the work (i.e. tasks) should be beneficiaries, and not linked third parties. Linked third parties should only exceptionally perform a major part of the R&I work.
Unless otherwise agreed with the Linked Third Party, the beneficiary should transfer the money to the Linked Third Party after it has received it from the coordinator.
We are not sure if we understand your question correctly.
As a general rule, entities performing a substantial part of the work (i.e. tasks) should be beneficiaries, and not linked third parties.
Subcontracting to affiliates is only allowed if there is a framework contract or the affiliate is the usual provider, and the subcontract is priced at market conditions. Moreover, an affiliated entity is not automatically considered a Linked Third Party of a beneficiary, but only if it has been identified as such in the Grant Agreement.
No, a CFS is not required in this case.
It can be a Linked Third Party if it is under the ‘direct or indirect control’ of the beneficiary. This means that the large company must (directly or indirectly) hold of more than 50% of the nominal value of the issued share capital, or a majority of the voting rights, or the decision-making powers in the R&D unit.
A unit cost is a ‘fixed amount’ per unit which is charged instead of a price which has ‘actually incurred’ by the beneficiary. Regarding SME owners: SME owners not receiving a salary must declare their personnel costs on the basis of unit costs (an hourly rate fixed by the Commission).
We understand you are referring to third parties of Linked Third Parties. Since Linked Third Parties are subject to the same conditions of eligibility as beneficiaries, they may also declare costs of in-kind contributions provided by third parties.
An “action task” is a task of the project described in Annex 1.
The beneficiary will reimburse the actual direct costs. Concerning the reimbursement of the indirect cost two different cases my apply: either not taken into account if the in-kind contribution is used in the premises of the beneficiary or taken into account by using the 25% flat-rate if the in-kind contributions are used in the third party’s premises. In this case, the direct costs actually incurred by the third party may be increased by a flat-rate of 25% on those costs. For more details and examples see annotated Grant Agreement Article 11.
Advantage: no legal link is necessary so also third parties with no legal link are able to provide in-kind contributions
Disadvantage: the third parties are not able to do project work on themselves whereas linked third parties are able to do some project work
By definition, a third party providing in-kind contributions does not perform any work in the project, so it does not play an active role in the project. Even if it seconds personnel to a beneficiary, this personnel works under the instructions of the beneficiary and not of the third party. In contrast, a Linked Third Party actively carries out work in the project.
The beneficiaries may declare their costs for paying the in-kind contribution (e.g. the invoice from the third party), but only up to the costs actually incurred by the third party. If an audit shows that the costs declared by the beneficiary are higher than those actually incurred by the third party, the difference will be rejected as ineligible (even if they correspond to the amount actually paid by the beneficiary).
A selection procedure regarding in-kind contributions by third parties is not required by the Grant Agreement. However, every beneficiary must respect its usual practise (i.e. its internal rules) and comply with the national public procurement law, if applicable.
Regarding your question about existing laws, we are not quite sure what you mean.
If the in-kind contribution is declared as a cost, it needs to be supported by evidence. Therefor, personnel provided as an in-kind contribution free of charge need to be supported by time records or a declaration on exclusive work on the action.
For information on tax regulations in a specific country, please contact your internal support facilities or tax consultant.
The estimated budget (Annex 2) may be adjusted by transfers of amounts between beneficiaries or between budget categories (or both) as long as the project is implemented as described in Annex 1.
A receipt does not necessarily lead to a reduction of the grant, but only if the receipt would produce a profit at the level of the consortium. Please see article 5.3 of the Grant Agreement for further information.
‘Financial support for third parties’ is an option which is not applicable in most grants; it has nothing to do with ‘in-kind contributions provided by third parties’.
If the in-kind contribution is free of charge (or, as you write, ’without payment’), the university does NOT receive a payment for seconding the PhD candidate. If the university charges the beneficiary for providing the PhD candidate, this is considered an ‘in-kind-contribution against payment’. The beneficiary charges the costs it incurs under the category A.3 (costs of personnel seconded by a third party against payment) and reimburses the university.
No, they are not considered as in-kind contributions. If the experts are paid a fee, the relationship would usually be considered a contract or subcontract.
In-kind contributions by third parties are only considered receipts if they have been provided by the third party free of charge and specifically to be used for the action, and declared as an eligible cost by the beneficiary. Since the beneficiary receives both a free-of-charge service (by the third party) and a financial reimbursement for the costs borne by the third party, these in-kind-contributions are likely to produce a profit.
Clinical Trials (96)
You cannot start any project activity without ethics approval. Ethics approval is not required by the time you submit your proposal (even though you should add any relevant documentation that you already have in place), but is indispensable for the start of activities. If your project is selected for funding and your ethics approvals are not in place yet, you should start the procedure immediately. Once you obtain your ethics approvals, they have to be submitted to the EC.
If possible, try to address the issues that were raised and led to the rejection, so that you fully comply with the requirements of the Ethics Committee and file again. If it is clear that you cannot get approval for that center, you have to adjust your workplan and recruit from different centers. In any case you cannot start any project activity without ethics approval.
Please follow the EU regulations on IVD: http://www.namsa.com/blog/View/entryid/190/blogid/2/update-on-the-new-eu...
It is sufficient to describe how you are planning to deal with ethical concerns and what the status of your ethical approval process is. To emphasize the likeliness and to increase the credibility that the ethical approval will be granted for this trial, it is helpful to mention your experience with any similar Clinical Trials (e.g. on national level) and explaining that you received ethical approval for those.
Yes it is necessary. The ethical approval will only be granted if the CT will be performed according to GCP.
According to the European Commission’s website on Medicinal products for human use http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm and the respective document, http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_53..., the directive has been effective since April 2014.
You should mention the national Ethic regulations of the respective countries and state that you will perform your trials in accordance to those.
Approval needs to granted by EMA, but they offer a lot of assistance - contact them EARLY enough! The FDA approval might help as enabler/ door opener so you might receive Orphan drug designation earlier.
Regarding the very limited information given here, we strongly recommend to contact your local National Contact Point for "Legal and Finance" which you can find here: http://ec.europa.eu/research/participants/portal/desktop/en/support/nati... and Financial/1/1/0&+person.last_name/desc
If you are in doubt of the financial situation of your company, you can find information on the financial viability self-check here:
In principle, a change of coordinator is possible, but needs to be very well justified.
Beneficiaries must award the subcontracts ensuring best value for money or, if appropriate, the lowest price. The best value-for-money principle does not require competitive selection procedures in all cases. However, if a beneficiary did not request several offers, it must demonstrate how best value-for-money was ensured. For the best price-quality ratio, price is an essential aspect (together with quality criteria, such as technical quality, etc.), but it is not automatically necessary to select the offer with the lowest price. In order to provide a good analysis of the price-quality ratio, the criteria defining ‘quality’ must be clear and coherent with the purposes of the action task that is subcontracted (AMGA, §13, S. 130-135).
It is OK to subcontract in general. But it depends on the nature of the tasks. Core tasks cannot be subcontracted, they have to be done by partners. Minor tasks can be subcontracted. If subcontracting, you have to do so via procurement according to your organization's rules. So you cannot name the organization which will be subcontracted in the application.
In this case you will have to make an amendment to your grant agreement. I understand that it is getting more difficult to add amendments. I would recommend to plan as conservative as possible and try to include "enough" study sites. We are not sure how high drop-out rates will be handled.
The EC prefers to include study sites as partners. Other options are to subcontract the task (Attention: Only minor tasks can be subcontracted), to include them as In-kind contributions provided by Third Parties against payment or affiliated entitities and third parties with a legal link to a beneficiary. Please refer to slide 29 and 30 of the first presentation (webinar on 18.3.2015) for details. If you need to add study centers during the running project, it depends on how you have included them in your project. If you need additional partners, you have to file an amendment.
Including them as a beneficiary is always the preferred option. However, subcontracting is also possible. This has to be decided individually for each project. The document “Frequently Asked Questions” concerning the Horizon 2020 societal challenge “Health, demographic change and wellbeing” says: Every clinical center can be a beneficiary, and the Commission will not oppose or discourage a large number of beneficiaries for this purpose. Alternative ways to include and reimburse such clinical centers are:
(i) As third parties providing in-kind contributions against payment (Art. 11 of the grant agreement). A requirement for this is a written agreement between the beneficiary and the third party prior to the start of the work. These third parties need to document their costs in the same way as beneficiaries (actual costs or unit costs). Wherever possible, third parties should be listed in section B4.2 of the full proposal.
(ii) As subcontractors (Art. 13 of the grant agreement). In this case, the beneficiary needs to ensure that it complies with the obligation to ensure the best value for money and institutional rules for subcontracting and if the beneficiary is a public body, with national and EU legislation on public procurement. Subcontractors would not usually be named in a proposal given the necessity to undertake the processes required to ensure compliance with the conditions described above. If however such processes have been undertaken in advance, subcontractors may be named in a proposal.
(iii) Another option, to participate as ‘linked beneficiary’, is limited to entities that fulfil the specific conditions of Art. 14 of the grant agreement on ‘affiliated entities and third parties with a legal link to a beneficiary’. As these conditions are rather specific, the use of this option is likely to be limited.
Please have a look at the FFH website: http://www.fitforhealth.eu/news/new-fit-health-20-partner-search-and-mat....
The clinical study partners should be partners= beneficiaries whenever possible, this is right; but in PHC12 only SME are eligible for funding. So you either can identify a for-profit CRO that is willing to act as beneficiary (as it is 100% funding rate this is not too bad), or they act as subcontractor. If you are or prefer working with non-profit CROs or with academic partners (university hospitals), they must be subcontracted for this topic. The commission is aware of the dilemma, but confident that the amount of subcontracting will not be a major hurdle for the applicants respectively the evaluation result. Note that in PHC12 like in any other SME instrument topic, the “impact” is even more important than in research & innovation actions, compared to “excellence”. This is: plan and write your project proposal in the best way for your company so that you will be able to become a champion in your market.
That is what EC told us. Sorry we do not know more on that.
"Too much" is not budget-wise. It is referring to amount and scope of tasks: how central/ crucial is the task you are going to subcontract, compared to the rest of you project?
No and yes, the task to be subcontracted must be named in the application, but not the name of the subcontractor. For any subcontracting, respect the guidelines on procurement (European, national and of your institution).
It is possible to include a CRO.
There is a partner search tool on the FFH2.0 website which you may want to check out for this purpose: http://mm.fitforhealth.eu
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”.
Regarding the description of CT in PHC 12 (SME instrument) the same "instructions" apply as to the description of CT in projects addressing other SC1 topics where the template is not mandatory.
That means: The template should be used as a checklist or guidance document and all information about the trials that is requested in the template should be provided in the Concept and Approach section of part B of the proposal application.
Since projects funded under the SME Instrument should focus on the exploitation of the results (closer to market) this should be considered as well. Since funding of projects with only one SME as partner is possible under the SME-Instrument, it is possible to subcontract the CT (but again: subcontracting rules apply), so in this case the expertise for the CT does not have to lie within the consortium (and this is even not possible in case of only one SME).
Yes it is correct that for PHC 12, the clinical trial template is NOT mandatory. Info regarding the trial needs to be included in the main template (= Part B).
Yes, but not in a separate template.
Yes, and as topic says: you should have granted the orphan drug designation at the time of stage 2 submission.
The topic says “based on clinical trials and/ or real world data”. Duration depends fully on your concept and approach.
I understand the topic PHC 12 in a way that it can be and/ or medical device, so I would say, the evaluators have decided accordingly.
No, not compulsory (mandatory), but EC sees good chances that applicants will present "Concept & approach" where CT is a part of. If you will not conduct a CT in such a topic (*), please reflect on the budget. Of course the budget has been drafted to fund CT as part of the project.
Reviewers may have different backgrounds. Therefore the proposal should be written in such a way that it can also be understood and assessed by an evaluator who is not an expert in exactly that scientific field.
Any documentation that you have at the time of submission should be added to the proposal. If you do not have the final informed consent form, you could for example add a draft version. Ethics approval is definitely required before starting related project activities, and need to be submitted to the EC as soon as they are obtained during the project.
As much as necessary to understand why the study needs to be done. The template does not specifically ask for scientific background. But you need to describe the background under Concept & Approach in Part B of your proposal.
You should use the template as a "checklist" to make sure you cover all relevant aspects. All relevant information needs to be mentioned in the proposal body (Concept & Approach; Part B) in those cases.
You should use the template as a guidance document. Although there is only limited space in stage 1 proposals, you should include all info that is important for the reviewers to understand what you are planning to do and that you have considered all important issues (according to the template).
Yes, you give as many details as you are able to give at that moment. The later the CT will happen, the less details you will know at the time of application. Evaluators need to be convinced, nevertheless, so at least give a vision of your idea.
Evaluation criteria are applied for chapters 1-3 only. As I mentioned, I would put as much info as possible into the chapters which are not page limited, but you should of course MENTION them in chapter 3 as well (and make reference to the extended versions).
In that case you have only one reporting period.
That depends on the topic.
No, project funded in 2019 for example will definitely continue after 2020.
There are no rules on the duration of H2020 projects. It depends on the nature of your project. The average project duration is between 3-5 years.
No, there are no guidelines on that. You should include as many participants as needed to successfully conduct the CT / project. So it totally depends on your project.
Any work related to the observation of, data collection from or diagnostic or therapeutic intervention on patients is defined for the purpose of using the template and thereby is a CT.
There is no EC definition of ‘major change’. It is up to the evaluators to decide whether a change is significant or not. In some calls (e.g. LEIT-BIO; SFS ), consortia were asked to list any substantial differences between the 1st stage & 2nd stage proposal (i.e. changes with regards to partnership, budget, approach, workplan) and indicate the reasons in the proposal submission forms.
Say as it is – we have this, we are here, but xyz is not yet precisely projectable.
With regards to “realistic” 6 years might be better than 5 years – so you need to argue accordingly. With regards to credibility and manageability – I would not recommend to prolongate the projects too much. The longer a project is, the more may happen meanwhile which affects results etc. You might rather consider to leave out 1 or 2 Work steps and make the project more tiny and focused.
EC told us that a cost-neutral prolongation of EU projects will be more difficult now, compared to FP7. I would say that in worst case, you will not be able to deliver all deliverables that you are committed to (Grant agreement), so that you might lose some of the final funding portion.
Please refer to the following presentation explaining that usability study is no clinical study: http://de.slideshare.net/Banderlin/usability-testing-medical-devices.
Please see here for non-pharmaceutical products: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/gen.... In general, we advise you to contact your national competent authority very early - and you might get great support from ethic committees located at your local/ regional university hospitals etc.
EC does not make big differences here. They clearly say (in the additional template) that they have a very broad definition of CTs - as long as you COLLECT human data (patients/ volunteers). Sure all we are presenting today is applicable for psychological therapy. Whenever a question in the template is not to answer, just write "not applicable".
For the purpose of the Template, a clinical study is defined as any clinical research involving a substantial amount of work related to the observation of, data collection from or diagnostic or therapeutic intervention on multiple or individual patients. It includes but is not limited to the clinical trials in the sense of the EU Clinical Trials Directive (2001/20/EC). So according to this definition would be regarded as a clinical trial.
Collecting data from or diagnostic or therapeutic intervention on multiple or individual patients is considered a clinical trial and the template needs to be submitted. If you are not sure, if your work would be considered a CT, we recommend to fill in the template to be on the safe side.
You should use the template as a guidance document. Although there is only limited space in stage 1 proposals, you should include all info that is important for the reviewers to understand what you are planning to do and that you have considered all important issues (according to the template).
For these topics you cannot upload the clinical trial template as a separate document, but you should use the template as a guiding document include this information in your proposal.
The template for essential information on clinical trials is mandatory at stage 2 (full proposal) for projects addressing all topics marked with an asterisk in the slides (slides are available on the FFH2.0 website) or indicated on the template.
You are supposed to fill in the template for each study, no matter how many study centers will be invlvoved in one study. If you have 3 Studies included in your project, you'll have sections 1-9 filled in for each of those (1.1, ...1.9; 2.1,...2.9 ....), please remember to upload everything as one single document.
There is one template consisting of 9 sections. All sections have to be completed for each study of your project. So there will be one single document to be uploaded containing information (section 1-9) for each study.
As a separate document.
Yes, this was a technical mistake.
In the version of August 2014 it is mentioned: " Single-stage- and stage-2 proposals: The use of this template is mandatory for all clinical studies included in a single-stage- or stage-2 proposal submitted to topics PHC-2, PHC-3, PHC-11, PHC-14, PHC-15, PHC-16, PHC-18, PHC-22, PHC-24, PHC-33 and HCO-62. For these topics, you will have the possibility to upload the completed template as a separate part of your application in the submission system."
The template can only be uploaded for those topics that are marked accordingly. For all other topics, you can use it as a 'checklist' to make sure you cover all relevant aspects, but cannot upload it. All info needs to be mentioned in the proposal body in those cases.
Annexes are to be uploaded with the full proposal, and yes, accessible for the evaluators. You do not have to repeat everything in the proposal body, but can be more concise there and make cross references to the annexes. In stage 1, you must be very brief, as the overall page limit is the same for all proposals, including those that entail clinical study elements.
Some of the information that is part of the protocol will also appear in the proposal body at places where you describe your study. The protocol as such can be included in a draft version as part of the extra documents that are to be uploaded. The final protocol does not have to be part of the proposal.
Recruitment should be very closely monitored. There are different software or web-based solutions available that can indicate recruitment progress at the different sites and on project level. As a coordinator, it is advisable to have access to this information in real time throughout the implementation period of the study.
There are certainly other funding opportunities as well. Fit for Health is specialized in providing support for Horizon2020 participation though.
The sponsor should not have significant say in the study protocol so that it will still be seen as “investigator initiated”; also, sponsor shall not have access to raw data/ uncoded data.
To be eligible as a coordinator , or getting financial support in some conditions, a company needs to have its financial viability checked The Commission provides this user-friendly electronic tool for applicants so that they could simulate the financial viability check of their organisation for their own information. The tool uses the ratios described in the "Rules on verification of existence, legal status, operational and financial capacity". It is available on "Partcipant Portal" at http://ec.europa.eu/research/participants/portal/desktop/en/organisations/lfv.html
As you posted your question in Fit for Health website you might be particularly interested in the rules in the Health topic in which the US have a special status. Due to a bilateral agreement US partners are having automated access to funding from H2020. It is important to understand that this only applies to the topic 'Health'.
You can find this in the footnote 29 on page 73 of the Health Work Programme: 'In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under all topics in calls under the Societal Challenge ‘Health, demographic change and well-being’.
Only exception is PHC12 (SME Instrument) in which appicants have to be established in a MS or AC (whether subcontracting to a US partner is possible is not specified so I would contact the programme officers about this.)
For all other topics in H2020 , If a grant applicant can convincingly demonstrate that without the participation of a US partner the objectives or impact of the proposal cannot be achieved, the EC can allow the US partner to access funding. But the case has to be really convincing. If you have a US partner who has a specific expertise, a patent, market access or anything that cannot be found within the EU then you may have such a case. What you should definitely avoid is to make the impression that you look for EU funding for research activities and that a significant part of the exploitation or market uptake (hence a large part of the expected turnover) will be generated in the US.
However, if the US partner for example allows a European SME to access the US market, this would be a pro for adding a US partner.
In any case, if you are planning to involve a US partner we strongly recommend to contact the assigned project officer or at least your NCP to get a better idea about the official take on things
You can find a list hereunder, describing the various instruments in Horizon 2020 and the according eligibility conditions
|Research & innovation action||Three legal entities. Each of the three shall be established in a different Member State or associated country. All three legal entities shall be independent of each other.|
|Innovation action||Three legal entities. Each of the three shall be established in a different Member State or associated country. All three legal entities shall be independent of each other|
|Coordination & support action||One legal entity established in a Member State or associated country.|
One for-profit SME. Only applications from SMEs established in EU Member States or countries associated to Horizon 2020;No concurrent submission or implementation with another phase 1 or phase 2 project.
Three legal entities. Each of the three shall be established in a different Member State or associated country. All three legal entities shall be independent of each other.Participants in ERA-NET Cofund actions must be research funders: legal entities owning or managing public research and innovation programmes
|Pre-commercial procurement (PCP) Cofund & Public procurement of Innovative solutions (PPI) Cofund||
Three legal entities. Each of the three shall be established in a different Member State or associated country. All three legal entities shall be independent of each other.A minimum of two independent legal entities which are public procurers from two different Member States or associated countries.
You can find a series of health-related topics in doing a keyword search under the European Commission > Research & Innovation > Participant portal
Click Here to search for topics by keywords
In addition, see all the open calls of Marie Sklodowska-Curie actions (MSCA) and European Research Council (ERC) grants for individual researchers of any nationality and research teams. The MSCA grants include opportunities for companies and SMEs. The MCSA and ERC grands are not restricted to specific topics.
The idea should hit as exact as possible the wording of the topic.
Please contact your National Contact Point to clarify if and where your project idea can be positioned in the Horizon 2020 Health thematic.
You can provide your recommendations through workshops organised by the EC, via ongoing projects, or by contracting the Programme Committee members in all countries of the future consortium
What means Horizon 2020 and what will be the main advantages for me as an SME?
You can find a detailed description about the participation in the new SME-instrument, in the collaborative projects, as well as information about access to Debt and Equity Financing in the Participants portal.
As opposed to other instruments, the SME instrument (Phase 2) does not have any restrictions when it comes to subcontracting of tasks; see article 13 (p. 370):
The rules on subcontracting for SME Instrument Ph2 actions are similar to those of the General MGA (see Article 13 General MGA).
However, subcontracting is not restricted to a limited part of the action.
This means that the participating SMEs can subcontract the services of a CRO and/or a hospital without a problem.
As phase 1 and phase 2 will be considered as different projects, and for different steps in the innovation cycle you might need different partners, yes you can change partners.
Research organisations can only be subcontractors, this is possible in both phases (depending on the topic); it depends on the applicants - what they intend to do during the phase 1 or phase 2, and for which kind of activities they ask for funding.
No problem from where your consortia partners are coming from, provided that the SMEs are established in a EU-member state or associated country; SMEs can be from the same country - but make sure that you can show that the business idea will be disseminated Europe-wide esp. internationally (which might be easier with partners from different member states).
As long as your company has an application for phase 1 or 2 open, OR has a phase 1 or 2 project running, you cannot apply again. For phase 3 application which is not yet possible, we do not know.
An application for a collaborative project is not interfering with an application for the SME instrument.
Yes, the restriction is only WITHIN the SME instrument
As subcontractor that MIGHT be possible, but as PARTNER definitely NOT
The high growth potential is intended to help Europe achieve the EUROPE 2020 goals which is: jobs, jobs, jobs!
Innovation has many facets; important ones are of course SUCCESS. How many new products/ technologies have your company launched successfully in the past years, how many patents filed, etc.? If you can show this for past innovations, evaluators might trust you that with your new idea you will be successful again.
Those SMEs are legally not excluded, but the commission aims at SMEs with HIGH growth potential with at least European market potential; as a start-up or very small company this might be difficult to argue, but most important will be the POTENTIAL.
SME-Phase 2 (1)
The Commission would like to give higher chances for phase 2 applicants, but of course this depends on the number of applicants. SMEs that have gone through phase 1 first MAY have some advantage when applying to phase 2 - as the Commission likes to have SME go through all the phases (make it properly).
A complementary funding is not excluded in the work programme.
The commission does not ask for financial details, so no hourly rate; just try to reach the 71,000 euro (of which the 70% will be reimbursed as the lump sum).
The 50.000 EUR can be used for any kind of activity (personnel costs, subcontracting, costs for patent search etc).
The lump sum will be paid in two portions - 40% with project start, the rest afterwards, at end of project. The projects that you might get financed as phase 1 and phase 2 are seen INDEPENDENTLY.
Pre-clinical studies would be TRL 3 (maybe even lower); for the commission, clinical studies phase I and II is still research (could be TRL 4); so far we have never received such a "translation" of TRLs into medical research but will push for it.
For the section 4 talking about the members of consortium, there is no page limit; but for sure you should not go too much into details - and only list experiences relevant for your proposal. Try to be precise and to the point.
Yes for the PHC topic, funding rate is 100%
No, the feasibility assessment in phase 1 is addressing activities like risk assessment, description of bottlenecks, market study, user involvement, IP regime, partner search etc. Clinical studies are activities planned in phase 2.
Please use the definitions as shown here (and please see also the corresponding literature)
A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NHI Biomarkers Definitions Working Group; 2001)
A valid biomarker is defined as “a biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is an established scientific framework or body of evidence that elucidates the physiologic, toxicological, pharmacologic, or clinical significance of the test results
(FDA. Guidance for industry - pharmacogenomic data submissions. 2005)
They will be rejected with the possibility to resubmit an improved version.
Yes. In principle you can directly apply for phase 2; this really depends on how far advanced you are with your market assessment/business plan (for phase 2 you really need some deep insight into your market and competitors!) At the end of phase 1, you will write a short final report. As summary of your findings, you will come up with a conclusion of your feasibility study.
This can be: yes it is feasible, but we need xyz budget for conducting this and this --> go and apply for phase 2; if you come to other conclusions (no freedom to operate; no market, market not attractive enough or too complicated,...) you will of course NOT continue the development and not apply for phase 2.
Yes. You can download it under http://ec.europa.eu/research/participants/data/ref/h2020/call_ptef/pt/h2020-call-pt-sme-1_en.pdf
Any SME must be (re)checked, if it was not validated within the last two years.
During the submission process you can name up to 3 people (companies) you wish to exclude; honestly, I would also write it on the cover page of part B.
At least 2 evaluators are planned to evaluate a proposal.
The obtained results in phase 1 will be reported at the end of this phase, but not evaluated once again. However, those results are the basis for the application in phase 2 (and consequently will thus be evaluated when submitting a proposal for phase 2).
Yes, reporting periods such as once a year; the general rules H2020 apply.
You have to provide a report at the end of the project. This will comprise a business innovation plan, recommendations for further, additional activities and your private financing needs as well
EASME is working on a database that is not ready yet. EEN will be included in this.
Business Coaches are selected from a pool that is offered by the EC. You will select one of them based on his/her expertise, as of course there are specialists in the particular fields that can assist you. Together with the coach you will work on a coaching plan for phase 1 and coaching will be important also to help you in preparing the application for phase 2. This procedure is intended to be accompanied by the Enterprise Europe Network (EEN).
The SME instrument is targeted at all types of innovative SMEs showing a strong ambition to develop, grow and internationalise. It provides staged support covering the whole innovation cycle in three phases complemented by a mentoring and coaching service. Transition from one phase to the next will be seamless provided the SME project proves to be worth further support in a further evaluation. Each phase is open to new entrants.
a) SME instrument (phase 1)
Description: Feasibility study verifying the technological/practical as well as economic viability of an innovation idea/concept with considerable novelty to the industry sector in which it is presented (new products, processes, design, services and technologies or new market applications of existing technologies). The activities could, for example, comprise risk assessment, market study, user involvement, Intellectual Property management, innovation strategy development, partner search, feasibility of concept and the like to establish a solid high-potential innovation project aligned to the enterprise strategy and with a European dimension. Bottlenecks in the ability to increase profitability of the enterprise through innovation shall be detected and analysed during phase 1 and addressed during phase 2 to increase the return in investment in innovation activities.
Funding rate: Funding will be provided in the form of a lump sum of EUR 50,000 (70% funding rate).
b) SME instrument (phase 2)
Description: innovation projects that address a specific challenge and demonstrate high potential in terms of company competitiveness and growth underpinned by a strategic business plan. Activities should focus on innovation activities such as demonstration, testing, prototyping, piloting, scaling-up, miniaturisation, design, market replication and the like aiming to bring an innovation idea (product, process, service etc.) to industrial readiness and maturity for market introduction, but may also include some research. SMEs can subcontract or buy in work and knowledge that is essential for their innovation project in the spirit of the innovation voucher concept. Proposals should be based on a strategic business plan either developed through phase 1 or another means.
Funding rate: 70% [or in exceptional cases, where the research component is predominant, the reimbursement rate may be 100%, as specified in each topic].
c) SME instrument (phase 3)
Support to commercialisation promotes the wider implementation of innovative solutions and customers and supports financing of growth by facilitating access to public and private risk capital. This stage will not provide for direct funding, but SMEs can benefit from indirect support measures and services as well as access to the financial facilities supported under Horizon 2020.
d) Mentoring and coaching
Each beneficiary of the SME instrument will be offered business coaching support during Phase 1 (up to 3 coaching days) and Phase 2 (up to 12 coaching days) in addition to the grant offered. This support will be provided through the Enterprise Europe Network (EEN) and delivered by a group of qualified and experienced business coaches. The local EEN office will introduce the beneficiary to the coaching process and propose a selection of coaches from the database managed by the Commission for the beneficiary to choose from. The objective is to accelerate the impact of the support provided through the SME instrument and to equip beneficiaries with the necessary skills, business processes and relevant competencies for long-term growth. Phase 3 does not include individual business coaching, but SME instrument participants will be able to count on continuing EEN support in linking to relevant support services within the Network, regionally or nationally. It is important to note that the objective of coaching is not to support the company in project management or reporting obligations related to Horizon 2020 participation.
Please use the Fit for Health 2.0 support network and publish a profile on the Fit for Health 2.0 match-making facility
IPR Issues (1)
The type of protection needed depends on the nature of the results. In case Intellectual Property Rights come out as necessary it should be recommended choosing the adequately IPR that suit with the aim of the project and be the most cost efficiently. Grant agreement contents specific rules to follow, for instance, the obligation to adequately and effectively protect the results got (“foreground”) and that is capable to industrial and commercial replication.
SMEs definition involves several criteria.
You can test them and see detailed explanation of SME-definition on http://flt.uwe.be/ . This site will allow you to answer an easy question: am I an SME or not ?
In principle yes.
Yes, subcontracting of clinical studies is possible.
Clinical trials can be subcontracted.
Out-licensing after Phase 2 can be considered as market uptake.
There is no exclusion of medical devices.
That is a risk you should address in your application.
Clinical trials can be sponsored. But the rules of this instrument have to be considered.
As far as all three participants are independent from each other this is fine. A subsidiary company and the correspondent owner company do not qualify as 2 independent participants.
No, it is not possible.
In principle is possible, but since this is still a pilot action with only 5 partners per consortium and due to the high number of proposals, we cannot foresee how the reviewers will compare such an application with other applications in which the coordinator also performs other core activities.
Yes, this is allowed.
Fit for Health 2.0 has a large database with companies and organisations interested in the health area of Horizon 2020.
As far as they comply with the FTI goals (delivery of a new educational concept in three years), then it is possible.
They can, but since FTI is allocated in part II (role of industry) and part III (societal challenges) of horizon 2020, they are not entitled to receive funding from Horizon 2020. Please contact the Swiss SME-NCP for clearing this.
Not as a partner.
Yes, there is no exclusion of small markets.
Universities are also eligible and they are reimbursed at a 100% rate.
They can apply.
In the case this new application addresses a challenge under horizon 2020 and is innovative enough yes.
Then it is not research infrastructure, but deployment infrastructure that should be checked in your specific case by your health NCP and SME-NCP.
Unfortunately not. Actions should focus on bringing a product or service to the market.
It is surely a decision criterium with equal points among several applications.
Yes, this is right.
Unfortunately, some of those documents are not available.
Reviewers are briefed by the agency taking care of the evaluation (EASME).
Yes, but the scientific expertise and design of prototype should be within the consortium. However, engaging a technical subcontractor for building the prototype is possible.
Under FP7 a Commission decision of 21/01/2011, Article II.14.1 of Annex II of the ECGA was followed to allow SME owners who do not receive a salary and other natural persons who do not receive a salary, to charge as personnel costs a flat rate based on the allowances used in the People Specific Programme ("Marie Curie" flat-rates).
Yes, as far as these processes are needed for an innovative service or product to be pushed to the previous steps before market uptake.
No. FTI is a grant.
Only development of most innovative products or services will be funded. If these are needed for scale up, then yes.
There is no explicit limit for subcontracting.
This is not possible.
If communication and interaction activities with potential investors or customers, or dissemination of milestone achievements during the project (under a work-package 'communication and dissemination activities') are necessary to implement the project, then those costs are eligible. Activities or products purely intended to support commercial purposes do not qualify as eligible costs.
You must already provide a rough strategy in your application. Design of tailored strategies can be funded.
Yes, as well as the preparation and fill of a patent.
If you mean analytical services, yes.
As coordinator you have to pass the financial viability check. If this raises problems, it might be better if another partner is the coordinator of the project.
As in any other Horizon 2020 project: personal, consumables, subcontractors...
Research should not be a main focus of an FTI action, so equipment for research is difficult to get funded.
For all innovation activities, a flat rate for indirect costs applies.
FTI-Specific aspects (16)
“on the market” can be sale of device after completion of clinical trials. But out-licensing after Phase 2 can be considered as market uptake.
There is not a rule for that.
Not reaching this goal will most probably have negative effects for the evaluation of the FTI instrument, but there will be no penalty for the consortium.
You should have the EU market in focus. If you can also deliver solutions for additional markets you can do so.
You should have the EU market in focus. If you can also deliver solutions for additional markets you can do so.
Yes, 36 months from project start.
There is no other limitation than the fact that the time to market-uptake has to be no later than 3 years after the beginning of the project. So the project must not exceed 3 years. Expected are projects of 1-2 years.
Although there are no formal limits in the Work Programme, you should note that in terms of impact, the expectation is that initial market take-up of the innovation should happen no later than 36 months after the start of the action.
A dissemination plan is highly dependent on your project! There is not such a template.
There are no limitations for target markets.
There is no penalty. You must convincingly explain this time to market, which risks you could face and how you could overcome them.
No, there is no limitation.
The PIC number must be new and not been used for FP7 projects
You must sound convincing in your application and offer solutions for overcoming that risk
This is right.
No, you must be a first-time applicant, meaning that you receive your PIC now for the first time.
You must convincingly explain in your application in which TRL step your product/service is.
It depends on how you will test your device. You can find further info here: https://www.medicalcountermeasures.gov/federal-initiatives/guidance/inte...
It depends on the country. In Germany SME-NCPs work together with the thematic NCPs.
You can find a comprehensive list under: http://ec.europa.eu/research/participants/portal/desktop/en/support/nati...
PIC number is related to your organisation. Your organisation should register for a PIC number.
For topic 1 and 2: Sanofi (Coordinator), Novo Nordisk (Co-coordinator), Eli Lilly(To be confirmed), Other potential partners are still under consideration.
The topic of personalised medicine is central to many IMI projects, for an overview, please consult the IMI projects database at http://www.imi.europa.eu/content/ongoing-projects
The RADAR topic is still under discussion between the industrial partners in order to ensure the involvement of other industrial sectors such as the imaging companies.
The IMI Project COMBACTE deals with antimicrobial resistance (AMR) http://www.imi.europa.eu/content/combacte
According to the Horizon 2020 „minimum conditions“ for participation,(a) at least three legal entities shall participate in an action;(b) three legal entities shall each be established in a different Member State or associated country;c) the three legal entities referred to in point (b) shall be independent of each other
For this question, I would recommend to contact the Italian Delegate to the IMI States Represenatives Group, Giovina RUBERTI (grubertiAT ibc.cnr.it ). Furthermore, you can check all running IMI projects at http://www.imi.europa.eu/content/ongoing-projects
Partner search for the 1st IMI2 Call via: http://www.imi-partnering.de
In Germany only for stage 2, not for the EoI preparation
I suggest to check the IMI Newmeds project as an example: http://www.imi.europa.eu/content/newmeds
Call 9 has unfortunately already closed, but clinical trials can be funded within IMI projects
When patient data are in use, research on animals, stem cells, and others specified on cordis web pages in section ethical issues…
You use the local and actual salary rates. You can use Lump Sums for International Cooperation Partner Countries (ICPC) ICPC got the option being reimbursed: the basis of eligible costs or may opt for lump sums lump sum contribution is defined per country income group in the „list of ICPC economies“:
Economy contribution (€/researcher/year) low income 8 000 €
lower middle income 9 800 €
upper middle income 20 700 €
upper funding limits have to be applied disadvantage of lump sum payment: it is deemed to cover all costs (see also: Guide to Financial Issues, p. 69 ff)
FP7 Financial issues (12)
This depends on the type of project and kind of organization ( SMEs, Universities, and/or others…) Please refer to the guidelines and Participant portal
The magnitude of research funding is usually specified by topic. It depends on the type of projects. Large, medium/small collaborative projects are from € 3 mil up to € 12 mil , the same for NoE
The key question is if the cost is a subcontract. If the services in question are a subcontract then the subcontract can not be taken into account when calculating overheads. The classification of the services depends on their character.
Some costs incurred in relation to organisation of the meeting may be considered as subcontracting (e.g. catering services provided by an external company) whereas others (renting the rooms directly in a hotel) would not fall within this category. ln this sense remember that subcontracting is a business transaction by which the subcontractor performs some work for a beneficiary.
Subcontracting costs are direct costs. Whether major or minor costs, they have to be identified by beneficiaries in the financial statement form (Form C, Annex VI to GA). In any case, they should be reported as subcontracting (if you are paying for a service; the difference is that the GA allows that these minor subcontracts do not previously appear in the Description of work of the project, As subcontracts, they are a cost to a beneficiary for a work/service which is performed by a third party and not by the beneficiary, and therefore indirect costs can not be charged by the beneficiary on them; in this cases, the indirect costs are already covered by the price paid by the beneficiary to the subcontractor. The same rules for subcontracting apply to all projects, including CSA.
If you use the flat-rate, overheads do not need to be justified. If effectively money is left over after covering your overhead this can be used any way. This of course does not apply if you calculate the actual costs!
It does not necessarily depend on the time if someone will be regarded as a subcontractor or as a real partner. It depends on the task one has in a FP7 project. Subcontracting is limited to side-tasks which are not central and crucial for development of the project.
The 375k€ limit applies for each project separately.
You only have to show the 3 offers in case of a second level audit by the Commission which can be done up to 5 years after the end of the project (good project documentation is needed!).
In our project we need to follow the progress of patients from different wards, GPs, home nursing organisations. They need to all fill-out a questionnaire and need to have their costs covered for this. Classical sub-contracting. There will be many (up to hundreds) of different organisations. We can't have a contract with them exactly, nor can we write out a call for the sub-contracting. What do we need to watch out for to ensure we follow the EU rules for sub-contracting?
In this case there should be a detailed description of the necessity of these people working in the project under Subcontracting in Annex I GA /DoW – this should be discussed with the PO/FO in detail as well as the costs.
Yes, of course. You are the owner.
Daily allowances are accepted by the commission if they are part of your normal operating accounting principles (“usual practice”).
In principle yes, when the cost cover flights and hotel fees as well as daily allowances only. It is always recommended to get a confirmation from your SO in advance. If it will be a substantial part of the project budget you should think about subcontracting.
Here the internal rules of your organisation apply. As the salary has to be according to the usual practice of the beneficiary it is always very problematic to get an EU-project bonus because this cannot be reimbursed in the project. If the top-up corresponds to more hours work for the beneficiary there is no problem – national labour law is the limit here.
It is advisable to find a partner that has more experience in managing the project and making sure that the joint application succeeds. The management and training activities are funded up to 100%, but not the project preparation. You can use the FFH 2.0 matchmaking section to find partners that offer project management skills for Horizon 2020
It takes on average one year including the evaluation phase, the negotiation phase and the signature of contracts. But these delays are now constantly reduced by a faster treatment of administrative procedures by the EC services.
Demonstration activities are closer to the product than research activities. Demonstration activities include e.g. prototype development, surveys, and up-scaling activities.
<p><strong>For clarity: dissemination includes everything from attending conferences to talk about results of the project to personnel costs for writing scientific papers about the project results to establishing and maintaining the project website. Is this correct?</strong></p>
Dissemination is everything you do to get the results / outcome of the project to the right target group(s)
The advice is to include an AB already in the project governance structure of the project at the first stage. It may help to convince the evaluators.
I would recommend integrating a Gantt or Pert Chart in first stage proposals only when you stick to the page limit. The Guide for Applicants does not foresee to have a Gantt or Pert Chart at stage one.
Our centre is a national consortium composed of research groups from different hospitals, universities, etc. If a research group applies for funds as part of the consortium, how do we reflect their belonging to other institutions?
Here it depends if your centre is a legal entity or not. If it is, then the Centre can apply for funding. If not, the hospitals, universities etc. should apply as partners.
If the centre is a partner and people doing the research work are not “directly hired” by the centre but have a working contract at a hospital, university which is member of the centre, then the costs of the personnel might only be eligible if the hospital, university is as a “third party linked to the beneficiary” with special clause 10 in the Grant Agreement working in the project.
When a hospital is a service provider who will not need to get access to other parties of the project it is a typical sub-contractor. On the other hand if a clinic is affiliated to one of the partners and likes to get access to the results and perhaps IPR then it should be involved as a third party linked to the beneficiary with special clause 10 (means: the partner is responsible for the reporting, the budget and the scientific quality and is steering the hospital as an affiliated partner/(third party).
After every reporting period there has to be a periodic report for the period (as well as a financial report Form C) – there also has to be a periodic report for the last period. After the last period a final report has to be handed in additionally. Reporting is done on-line via the Participant Portal.
It depends on the legal structure of the hospital. If the pharmacy is within the legal structure (is the same legal entity as the hospital), it is a part of the partner of the consortium and therefore “the partner”. If the pharmacy is a legal entity on its own, then it can be regarded as a third party linked to the beneficiary with special clause 10, when there is a link between the hospital and the pharmacy (holding structure, mother, daughter etc.). For the work in the project an agreement between the pharmacy and the hospital has to be set up.
Management depends on the complexity of the project.
Management can be much more detailed in difficult phases of a project. As a co-ordinator one of your tasks is to follow the progress of your project to avoid undue delays. Especially in the first phase of the project you need to monitor the people if they are on the right track. Delays in critical tasks will trickle down and have an effect of the entire project. The focus of all partners in a project has to be on agreeing on objectives.
As a co-ordinator you have to pay attention that the partners deliver their reports in time. Delays in reporting leads to a delay of the interim payments for the whole project.
Not necessarily. When you have a consistent, high-quality documentation system you can convince your auditor to take this instead of time-sheets.
But time sheets are default for most of the organisations, because they are easy to handle. The time recording needs to be signed and countersigned by either the project leader or the hierarchical supervisor. If the time recording system of your organisation is able to do this (e.g. by electronic signatures) then there are no time sheets needed. As the most organisations do not have such a system it is best to print out and sign and have counter-signed the time sheets on paper.
Each partner is responsible for the costs in the Form C and has to keep the documentation in its organisation (including the co-ordinator). But if a partner exceeds the amount of money he is allowed to spend it is the responsibility of the co-ordinator and the management board to monitor that. The co-ordinator is responsible for a good conduction of the project as well as for all the payments to the partners.
No, that is the responsibility of each partner (Annex II of the Grant Agreement). The partners have to be able to justify the costs of their Form C themselves until 5 years after the end of the project.
In FP7 the Commission usually audits 3 projects at a partner's place at once (for large organisations). A Commission' audit is always based on the organisational rules and the systems used in EU-projects. However, the EU COM audit unit has the power and the possibility to involve all other EU projects when they find a logical / consistent error that seems to be “systematic”. Then an extrapolation of the audit findings on all other projects is possible and all other projects may be recalculated.
Can you please tell me what the situation is with reporting in FP7? One of our deliverables should already be completed by Month 5 which has just passed. I have the information for the report. Should this be uploaded and submitted online now or can we wait for the reports of the 1st reporting period, after 18 months?
If you have arranged Month 5 for this deliverable in your Annex 1, this should be uploaded now. Here are some references from the relevant documents:
Guidance notes for reporting: 2.1 During the course of the project, to be submitted:
1. The deliverables identified in Annex I to the Grant Agreement, according to the timetable specified in the Deliverables list.
Guide for Applicants Health Theme: Please note that each deliverable will have to be submitted as a distinct document/report. In order to keep your deliverables manageable, small related deliverables should be grouped as specified parts (equivalent to 'subdeliverables') of a single more substantial deliverable. Progress towards achievement of the full deliverable can then be demonstrated in the periodic reports by reference to the smaller parts. The full deliverable will only be submitted when all parts have been -completed. Ideally this will be at the same date as a periodic report.
One single pre-financing payment
Received by the coordinator within 45 days of entry into force of GA, to ensure positive cash-flow during project. The pre-financing equals 160% of average EU funding per period for projects with more than 2 reporting periods, or it equals 60-80% of total EU contribution for projects with 1 or 2 reporting periods. The pre-financing remains the property of the EC until the final payment. Form the amount of pre-financing which depends on the project length, 5% of the total EU funding is transferred to the Guarantee Fund. During project implementation the amount reported in the Form C are paid by the EC (ownership of this money is transferred) – but only up to a limit of 90% of the total EU funding. (10% retention is kept until the final payment – with the final payment the Commission pays 10% as well as 5% are coming from the Guarantee Fund.
in FP7, every partner who receives more than 375.000 EUR or exactly 375.000 EUR funding has to give a certificate on financial statement (CFS). Together with the financial statement (Form C) which reaches the threshold of 375.000 EUR, the CFS has to be submitted. E.g. in the first period you receive 200.000 EUR funding – you need no CFS. In the second period you receive another 200.000 EUR funding – now you reached the threshold (as 400.000 EUR is more than 375.000 EUR), therefore you have to bring in a CFS. In the next (last) period you receive another 200.000 EUR funding – you don’t need a CFS as you don’t reach the threshold anymore. If you receive less than 375.000 EUR funding in a project, you don’t have to bring in a CFS at all. In projects with less than 2 years if you receive more than/or exactly 375.000 EUR funding, you only have to hand in a CFS at the end of the project. (The same is valid for organisations with a valid Certificate of Methodology, they don’t need a CFS for interim payments, just one at the final payment if they get >= 375.000 EUR funding). Costs for CFS can be reimbursed under Management – Subcontracting.
My question is in relation to direct and indirect cost in FP7. If we allocate some of the time of the Director of the Research Centre, where do we allocate this cost? As direct costs or personnel costs?
Here it depends if the Director receives a salary or not. If the Director does not receive any salary the Marie Curie rates can possibly be taken. Otherwise there has to be made the distinction if his salary is completely in the overhead costs (indirect costs). If so and he wants to get reimbursed hours in the project, these hours have to be taken out of the indirect costs and booked under the direct costs – only then these costs can be reimbursed under personnel costs. I just add here that a complete time recording for the Director is needed too.
If it is a project management or a project board meeting and if the dinner is necessary for networking among the consortium partners andis necessary to conduct the project, yes, it is possible to claim it on the project. But it needs to be justified for networking issues. Best advice is to ask the Project Officer in advance if the costs for a common dinner will be covered by the project. It is always good to have an agenda so you really can show that the dinner was a working dinner and not for entertainment. As it is with all costs, the dinner has to fulfil all the eligibility criteria and have to fall under the usual practice of the partner who wants it reimbursed in the Form C (e.g. the organisation only allows the cheapest caterer, then a 5-star expensive catering can never be reimbursed).
Yes, it is forbidden. Only complementary financing is allowed.
Any other issues (4)
The standard eligibility conditions for participation, depending on the type of action, can be found in the General Annexes to the Horizon 2020 work programme: http://ec.europa.eu/research/participants/data/ref/h2020/other/wp/2016-2....
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