No, it must be accompanied by the Decision on the authorisation of clinical evaluation for the Czech Republic and the SÚKL authorisation to conduct a clinical trial for the medical device. Only if it is not a clinical evaluation or clinical trial, the opinion of the...
It is no longer required; instead of this annex, it is necessary to answer two questions directly in the project proposal, namely whether "The project proposal corresponds to the clinical evaluation of medicines according to the provisions of Act No 378/2007 Coll., on Medicinal Products" and "The project proposal corresponds to the clinical trial of medical devices...
The opinion of the applicant's ethics committee must be submitted whenever the project involves the provision of health care, research with human subjects, and even in the case of research with a questionnaire survey methodology and qualitative research with persons affected by or at risk of disease in...
When submitting a proposal: In the case of a proposed project involving experimental work with animals, the applicant shall attach to the project proposal at least the "authorisation for the use of experimental animals" (former accreditation of the user facility) pursuant to Section 15b of Act No. 246/1992 Coll., on the protection of animals against cruelty, in...
The annex Draft Cooperation Agreement is to be submitted whenever the applicant is not the sole participant in the project proposal (i.e. whenever the project is a collaboration between the applicant and the coapplicant(s)); it is to be submitted via the ISVP application as an embedded PDF attachment. The draft contract does not have to...
For affidavits for project proposals, specifically under the heading "Type of applicant entity in terms of CEDR", use the codebook of legal forms (see e.g. ). All information on CEDR (Central Evidence of Budget Subsidies) can be found on the MFCR website: To fill in...
Yes, it is necessary to follow the outline prescribed by the LOI: Introduction - summary of the current state of knowledge of the scientific issues in the given scientific field; Preliminary/pilot data - pilot data supporting the project focus and hypothesis (d); statement of the nature of the project and its relation to...
Among the permitted annexes to the project, only the documents listed in the Tender Documents are allowed: - documents (according to the nature of the project) and affidavits to prove eligibility (Article 4.2 of the Tender Documents); - list of experts who should not assess the project (to ensure objectivity in the assessment of the project...
The annexes to the project proposal must be delivered during the competition period in paper form by post or in person to the office of AZV ČR at Ruská 2412/85, 100 00 Prague 10 in an envelope marked "DO NOT OPEN - VES 202X" or signed by a qualified...
Active participation in conferences means a presentation in the form of a lecture or poster with an abstract in a professional journal or proceedings, where the author is named and the topic must be related to the project and the presenter must be part of the research team, as a named...
