FAQ

Are the costs reimbursed through the academic CRO (participating in the project as a beneficiary) or through us as a partner hosting the national ECRIN?

Each beneficiary should budget its own costs. Costs should be budgeted in line with the project activities each partner is involved in.

In an EU funded clinical trial who is the sponsor?

In the conduct of a clinical trial, a sponsor is an individual, institution, company or organization.

Would it be possible to get an extension for your project due to e.g. changes in regulatory (EMA) guidance, which may cause a delay?

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.

How many (pre-clinical) efficacy and safety data needs to be presented under Heading 1.6?

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.

Is there a maximum of budget available for third parties and subcontractors?

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.

I understand well that unit costs should be the same for all beneficiaries?

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.

Do you have any suggestions on SMEs that are currently preparing for the preclinical phase?

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.

Where can I find a link to current H2020 calls?

http://ec.europa.eu/research/participants/portal/desktop/en/opportunitie...

Is it possible for a clinical partner to choose the Unit Cost modality, but quantifying also costs for management/of grant office? (Project Manager)

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).

Can CROs be a party making available resources against payment?

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.

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