FAQ

Could you please briefly restate the importance and role of the TEMPLATE?

The template for essential information on clinical trials is mandatory at stage 2 (full proposal) for projects addressing all topics marked with an asterisk in the slides (slides are available on the FFH2.0 website) or indicated on the template. Apparel

I would be more than grateful if you could bring more clarity on subcontractors participation in a clinical trial.

It is OK to subcontract in general. But it depends on the nature of the tasks. Core tasks cannot be subcontracted, they have to be done by partners. Minor tasks can be subcontracted. If subcontracting, you have to do so via procurement according to your organization's rules. So you cannot name the organization which will be subcontracted in the application. Dame

Does the EU finance clinical trials other than medicines or devices?

Depends on the topic. They also fund observational studies, if there is a respective topic for that.

Do we understand correctly that it will be allowed that one beneficiary makes a choice for unit costs while other beneficiaries opt for actual costs.

Yes that is correct. Each beneficiary can decide to be reimbursed on basis of unit costs or actual costs for a given clinical study.

If we only work on the collection of samples is that it falls within the principle of a clinical trial?

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. Air Jordan Releases 2019

If our project foresees a clinical trial to be performed in 4 different enrollment centers across Europe, how many templates should we fill in?

You are supposed to fill in the template for each study, no matter how many study centers will be invlvoved in one study. If you have 3 Studies included in your project, you'll have sections 1-9 filled in for each of those (1.1, ...1.9; 2.1,...2.9 ....), please remember to upload everything as one single document. Running Shoes, Trainers, Shorts, Spikes and Clothing

In the case of multicentered clinical trials, is there one document or one for each pilot?

There is one template consisting of 9 sections. All sections have to be completed for each study of your project. So there will be one single document to be uploaded containing information (section 1-9) for each study. Air Max

Can you add a study site at a later stage, i.e. while the CT is running as subcontractor although centers with the same tasks are listed as "partners" in the initial proposal?

In this case you will have to make an amendment to your grant agreement. I understand that it is getting more difficult to add amendments. I would recommend to plan as conservative as possible and try to include "enough" study sites. We are not sure how high drop-out rates will be handled. Zapatillas Running trail

How should the hospitals recruiting patients be included in the project?

The EC prefers to include study sites as partners. Other options are to subcontract the task (Attention: Only minor tasks can be subcontracted), to include them as In-kind contributions provided by Third Parties against payment or affiliated entitities and third parties with a legal link to a beneficiary. Please refer to slide 29 and 30 of the first presentation (webinar on 18.3.2015) for details. If you need to add study centers during the running project, it depends on how you have included them in your project. If you need additional partners, you have to file an amendment.

Who are the NCPs for this action?

It depends on the country. In Germany SME-NCPs work together with the thematic NCPs.

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