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Frequently Asked Questions (FAQ) - Project

Question details: 
Can you explain how the different Phases (I to IV) of clinical trials correlate with the TRL scale (1 to 9)? Which Phases of clinical trials can be funded under SME Instrument or Fast Track to Innovation, which both require a minimum TRL of 6?
Answer: 

That depends on the topic.

Answer: 

No, project funded in 2019 for example will definitely continue after 2020.

Answer: 

There are no rules on the duration of H2020 projects. It depends on the nature of your project. The average project duration is between 3-5 years.

Answer: 

No, there are no guidelines on that. You should include as many participants as needed to successfully conduct the CT / project. So it totally depends on your project.

Answer: 

Any work related to the observation of, data collection from or diagnostic or therapeutic intervention on patients is defined for the purpose of using the template and thereby is a CT.

Answer: 

There is no EC definition of ‘major change’. It is up to the evaluators to decide whether a change is significant or not. In some calls (e.g. LEIT-BIO; SFS ), consortia were asked to list any substantial differences between the 1st stage & 2nd stage proposal (i.e. changes with regards to partnership, budget, approach, workplan) and indicate the reasons in the proposal submission forms.

Question details: 
At the stage of the application, documents like informed consent form, information sheets, ethics approvals etc. are not available yet. These will often be established during the project. How should one deal with that?
Answer: 

Say as it is – we have this, we are here, but xyz is not yet precisely projectable.

Question details: 
Based on the points made about time planning would you expect the duration of a project including clinical trials to be longer than those under FP7, for example, 6 years instead of 5? Do you think this will be accepted by the Commission?
Answer: 

With regards to “realistic” 6 years might be better than 5 years – so you need to argue accordingly. With regards to credibility and manageability – I would not recommend to prolongate the projects too much. The longer a project is, the more may happen meanwhile which affects results etc. You might rather consider to leave out 1 or 2 Work steps and make the project more tiny and focused.

Answer: 

EC told us that a cost-neutral prolongation of EU projects will be more difficult now, compared to FP7. I would say that in worst case, you will not be able to deliver all deliverables that you are committed to (Grant agreement), so that you might lose some of the final funding portion.