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.
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 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:
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.