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Frequently Asked Questions (FAQ) - Clinical Trials Webinar 2017
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.