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TOPIC : Standardisation of pre-analytical and analytical procedures for in vitro diagnostics in personalised medicine

Topic identifier: SC1-HCO-02-2016
Publication date: 14 October 2015

Types of action: CSA Coordination and support action
DeadlineModel:
Opening date:
single-stage
20 October 2015
Deadline: 13 April 2016 17:00:00

Time Zone : (Brussels time)
  Horizon 2020 H2020 website
Pillar: Societal Challenges
Work Programme Year: H2020-2016-2017
Topic Description
Specific Challenge:

Standards are part of the knowledge economy that facilitate innovation and the adoption of new technologies. They are key elements of the competitiveness of European industry. They can improve safety and performance of products and services. Patients would benefit from the standardisation of in vitro diagnostic practice.

Progress in medical diagnostics is limited by insufficient guidelines for pre-analytical procedures and diagnostic services. The accuracy of measured values may be hampered by deficiencies of pre-analytical steps (sample collection, handling, etc.) and poor harmonisation and quality assurance of diagnostic practice (not all diagnostic laboratories are even accredited ISO15189).

Scope:

Provide pan-European quality assurance schemes and guidelines for pre-analytical procedures - such as sample collection, handling, transportation, processing and storing of clinical samples - and/or harmonisation and quality assurance of diagnostic practice.

The proposal should contribute to accreditation and certification, and participate in standardization activities at European level. Interaction with the European Metrology Programme for Innovation and Research (EMPIR) should be considered as appropriate. Outcomes could be coordination of validation studies, assessment of the results of method validations, training, counselling, quality procedures and guidelines.

Involvement of industry, including SMEs, and organizations for standardisation is expected.

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

Expected Impact:
  • Harmonisation and quality assurance of in vitro "diagnostic" procedures for disease diagnosis, patient stratification and/or prognosis of disease outcome leading to improved clinical decisions and health outcomes for the benefits of patients.
  • Contribution to the sustainability of health care systems by reducing the number of diagnostic mistakes.
  • Growth and benefit to the European diagnostics industry, in particular SMEs.
Delegation Exception Footnote:

Personalised medicine refers to a medical model using characterization of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time, and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention. The term "personalised medicine" is used throughout this Work Programme with this definition in mind.

Cross-cutting Priorities:

Gender

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.
 

  1. List of countries and applicable rules for funding: described in part A of the General Annexes of the General Work Programme.
    Note also that 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 (follow the links to China, Japan, Republic of Korea, Mexico, Russia, Taiwan, USA).

     
  2. Eligibility and admissibility conditions: described in part B and C of the General Annexes of the General Work Programme.

    Proposal page limits and layout: Please refer to Part B of the standard proposal template.

     
  3. Evaluation

    3.1  Evaluation criteria and procedure, scoring and threshold: described in part H of the General Annexes of the General Work Programme.

    3.2 Submission and evaluation process: Guide to the submission and evaluation process

          
  4. Indicative timetable for evaluation and grant agreement:

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

     
  5. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:

    Coordination and Support Action:

    Specific provisions and funding rates
    Standard proposal template
    Standard evaluation form
    H2020 General MGA -Multi-Beneficiary
    Annotated Grant Agreement

     
  6. Additional provisions:

    Horizon 2020 budget flexibility

    Classified information

     
  7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions, and proposals must refer to measures envisaged. 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.

     
  8. Additional documents:

    H2020 Work Programme 2016-17: Health, demographic change and wellbeing

    H2020 Work Programme 2016-17: Dissemination, Exploitation and Evaluation

    H2020 Work Programme 2016-17: General Annexes

    Legal basis: Horizon 2020 - Regulation of Establishment

    Legal basis: Horizon 2020 Rules for Participation

    Legal basis: Horizon 2020 Specific Programme

 

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