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Frequently Asked Questions (FAQ) - Clinical Trials
Please follow the EU regulations on IVD: http://www.namsa.com/blog/View/entryid/190/blogid/2/update-on-the-new-eu...
Yes it is necessary. The ethical approval will only be granted if the CT will be performed according to GCP.
You should mention the national Ethic regulations of the respective countries and state that you will perform your trials in accordance to those.
Please have a look at the FFH website: http://www.fitforhealth.eu/news/new-fit-health-20-partner-search-and-mat....
That is what EC told us. Sorry we do not know more on that.
It is possible to include a CRO.
There is a partner search tool on the FFH2.0 website which you may want to check out for this purpose: http://mm.fitforhealth.eu
Yes, costs of insurance can be part of the unit costs.
Depends on the topic. They also fund observational studies, if there is a respective topic for that.
Yes that is correct. Each beneficiary can decide to be reimbursed on basis of unit costs or actual costs for a given clinical study.
Any costs that will be reimbursed by health care providers/ insurance are NOT eligible for funding via the EU project.
Unit costs are partner specific - i.e. you will most likely have different unit costs for each partner.
Yes - they would have to be defined for that linked third party specifically in any case.
Yes, but not in a separate template.
Yes, and as topic says: you should have granted the orphan drug designation at the time of stage 2 submission.
The topic says “based on clinical trials and/ or real world data”. Duration depends fully on your concept and approach.
I understand the topic PHC 12 in a way that it can be and/ or medical device, so I would say, the evaluators have decided accordingly.
In that case you have only one reporting period.
That depends on the topic.
No, project funded in 2019 for example will definitely continue after 2020.
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.
Say as it is – we have this, we are here, but xyz is not yet precisely projectable.
As a separate document.
Yes, this was a technical mistake.
There are certainly other funding opportunities as well. Fit for Health is specialized in providing support for Horizon2020 participation though.