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Frequently Asked Questions (FAQ) - Topic-related Questions

Answer: 

Regarding the description of CT in PHC 12 (SME instrument) the same "instructions" apply as to the description of CT in projects addressing other SC1 topics where the template is not mandatory.
That means: The template should be used as a checklist or guidance document and all information about the trials that is requested in the template should be provided in the Concept and Approach section of part B of the proposal application.
Since projects funded under the SME Instrument should focus on the exploitation of the results (closer to market) this should be considered as well. Since funding of projects with only one SME as partner is possible under the SME-Instrument, it is possible to subcontract the CT (but again: subcontracting rules apply), so in this case the expertise for the CT does not have to lie within the consortium (and this is even not possible in case of only one SME).

Answer: 

Yes it is correct that for PHC 12, the clinical trial template is NOT mandatory. Info regarding the trial needs to be included in the main template (= Part B).

Answer: 

Yes, but not in a separate template.

Answer: 

Yes, and as topic says: you should have granted the orphan drug designation at the time of stage 2 submission.

Answer: 

The topic says “based on clinical trials and/ or real world data”. Duration depends fully on your concept and approach.

Question details: 
I raise the question because I now for a fact that a proposal for the development of an IVD without a biomarker involved has been funded, when a NCP told me that the diagnostic devices must always have to have a biomarker involved.
Answer: 

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.

Answer: 

No, not compulsory (mandatory), but EC sees good chances that applicants will present "Concept & approach" where CT is a part of. If you will not conduct a CT in such a topic (*), please reflect on the budget. Of course the budget has been drafted to fund CT as part of the project.