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TOPIC : Creation of a European wide sustainable clinical research network for infectious diseases

Topic identifier: SC1-HCO-08-2018
Publication date: 27 October 2017

Types of action: CSA Coordination and support action
DeadlineModel:
Opening date:
single-stage
07 November 2017
Deadline: 18 April 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2018-2020
Topic Description
Specific Challenge:

Infectious diseases pose a serious threat to global health. Emerging epidemics, pandemics and rising levels of antimicrobial resistance require a strong and coordinated response to protect citizens in Europe and beyond as indicated in the European One-Health Action Plan against AMR. There is a need to establish a clinical research network across Europe that has the capacity and capability to directly enrol patients with infectious diseases, to increase efficiency for testing and developing new diagnostic, preventive and/or therapeutic strategies and therapies. This should allow generating rigorous evidence to improve the diagnosis, prevention and treatment of infections and to better respond to infectious disease threats, and contribute to the G7 aim concerning the need to establish a global clinical studies network on drug resistance that provides access to a large clinical research infrastructure for the design, coordination and conducting of clinical trials and studies in cooperation with the existing global experts networks and infrastructures such as ECRIN[1] to ensure the common benefit of the outcomes[2].

Scope:

Proposals should build on successful European collaborative initiatives such as PREPARE[3] and COMBACTE[4] and further advance clinical research in the field of infectious disease by supporting the establishment of a European wide multidisciplinary clinical research network. Such a network should be capable of performing all clinical trial aspects encompassing study design, execution and reporting (sex and gender differences analysis to be included where relevant). It should develop and allow for innovative research approaches and enable flexibility in responding to unpredictable events and signals. The network should provide clear and direct access for stakeholders including academic organizations, SMEs and larger industry to perform clinical studies. The proposal should develop a business plan to ensure the sustainability of the network. The network should actively disseminate information and contribute to awareness rising. Furthermore, it should also create synergies with global initiatives, enabling quick and smooth interactions and collaboration across the world.

The Commission considers that a proposal requesting an EU contribution between EUR 2 to 3 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amount.

Expected Impact:
  • Reduce the cost and time of clinical trials for diagnosis, prevention and treatment of infections.
  • Attract industry back to invest in the development of anti-infectives.
  • Strengthen the operational capacity and the required infrastructures for clinical research.
  • Increase information exchange between sectors and scientific disciplines.
  • Maintain Europe's leading role in combating AMR and controlling infectious diseases.
  • Ensure global collaboration between networks in Europe and other countries/regions to optimise a coordinated response to infectious diseases.
Cross-cutting Priorities:

Open Science
Gender

[1]http://www.ecrin.org/

[2]http://www.mhlw.go.jp/seisakunitsuite/bunya/hokabunya/kokusai/g7kobe/KobeCommunique_en.pdf

[3]https://www.prepare-europe.eu/

[4]https://www.combacte.com/

Topic conditions and documents

1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.

2. Eligibility and admissibility conditions: described in Annex B and Annex C of the Work Programme.

Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.

3. Evaluation:

  • Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
  • Submission and evaluation processes are described in the Online Manual.

The thresholds for each criterion in a single stage process will be 4, 4 and 3. The cumulative threshold will be 12.
The same applies to the second stage of the two-stage call for topics SC1-BHC15-2018, SC1-BHC01-2019, SC1-BHC02-2019, SC1-BHC14-2019, SC1-BHC19-2019, SC1-BHC22-2019, SC1-BHC25-2019

4. Indicative time for evaluation and grant agreements:

Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.

5. Proposal templates, evaluation forms and model grant agreements (MGA):

Coordination and Support Action:

Specific provisions and funding rates
Standard proposal template
Standard evaluation form
General MGA - Multi-Beneficiary
Annotated Grant Agreement

Essential information for clinical studies

6. Additional provisions:

Horizon 2020 budget flexibility
Classified information
Technology readiness levels (TRL) – where a topic description refers to TRL, these definitions apply.

Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.

7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

8. Additional documents:

Introduction WP 2018-20
Health, demographic change and well-being WP 2018-20
General annexes to the Work Programme 2018-2020

Legal basis: Horizon 2020 Regulation of Establishment
Legal basis: Horizon 2020 Rules for Participation
Legal basis: Horizon 2020 Specific Programme

Submission Service

To access the Electronic Submission Service of the topic, please select the type of action that is most relevant to your proposal from the list below and click on the 'Start Submission' button. You will then be asked to confirm your choice of the type of action and topic, as these cannot be changed in the submission system. Upon confirmation you will be linked to the correct entry point.

To access existing draft proposals for this topic, please login to the Participant Portal and select the My Proposals page of the My Area section.

Type of Action Coordination & support action [CSA]
Topic Creation of a European wide sustainable clinical research network for infectious diseases - SC1-HCO-08-2018
Guidance on proposal submission: H2020 online manual
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