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TOPIC : Centre Of Excellence – Remote Decentralised Clinical Trials

Topic identifier: IMI2-2018-14-04
Publication date: 15 March 2018

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
15 March 2018
Deadline:
2nd stage Deadline:
14 June 2018 17:00:00
11 December 2018 17:00:00

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

For full details of the topic, please refer to the call text

Developing new medicines/health solutions and improving patient health rely on the successful conduct of clinical trials to generate relevant safety and efficacy data. Recruitment and retention of patients are some of the most challenging aspects in clinical trial protocol adherence. The 2017-global CISCRP survey reported the main barriers to patients’ participation as “lack of patients’ awareness of clinical trials” (~61%); and the “geography and the distance to the clinical site” (60%) . This geographical burden on patients, including the duration and number of clinical visits, also drives their decision to participate in a trial. In addition, within patients who consent, an alarming 30% dropout across all clinical trials is observed. Therefore, by the same token, improving the patients’ experience through protocol optimisation to ease the patient burden, whether perceived or real, should improve data quality and increase the probability of success.

Scope:

For full details of the topic, please refer to the call text

The action will focus on disaggregating the current model of running clinical trials, defining building blocks and mapping new technologies (e.g. telemedicine, mobile health…) to support the new DCT model. The objectives are: to demonstrate the feasibility of running remote DCTs in Europe. This will increase access of patients to clinical research, enriching clinical trial data from more diverse and representative patient population and improve patient experience during the trials, with a higher speed of recruitment and better retention.

Expected Impact:

For full details of the topic, please refer to the call text

  • Increase flexibility of patient follow-up during clinical trials, reducing the burden both on patients and hospitals
  • Increase the frequency and quality of data collection
  • Improve patient recruitment and retention in trials.
  • Accelerate clinical research and the access by the patients to more breakthrough innovative therapies.
  • Support directly the update of the ICH guidelines all along the process by generating evidence.
  • Reorganise the patient journey and the clinical environment
  • Redefine the clinical trial framework in compliance with the EU regulations.
Topic conditions and documents

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

The IMI2 JU 14th Call for proposals topics text as well as the Call Conditions are available here

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section, as well as the following information : 

 

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

 

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

 

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

 

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

 

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

 

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

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool

Standard evaluation form

IMI2 Model Grant Agreement

Clinical trial template – the Clinical Trial template is compulsory at stage 2 only !

 

6.   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 H2020 main 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.

 

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

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

IMI2 Amended Annual Work Plan 2018

IMI2 JU Annotated Model Grant Agreement

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

 


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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 Research and Innovation action [IMI2-RIA]
Topic Centre Of Excellence – Remote Decentralised Clinical Trials - IMI2-2018-14-04
Guidance on proposal submission: H2020 online manual
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