THE MOST IMPORTANT CHANGES IN THE TENDER DOCUMENTATION FOR THE 2017 ROUND COMPARED TO THE 2016 ROUND

THE PERSON OF THE PROPOSER OR CO-PROPOSER:

1.3 Definition of terms paragraph (12) Proposer (or co-proposer) - the condition that "thesame natural person may act as proposer and co-proposer for only one project proposal in this call for proposals" has been added.

- See also 5.2. General conditions for the submission of proposals, paragraph (3), 6.1.

- if this condition is violated, all such project proposals will be rejected on formal grounds!

SÚKL:

3.2. Programme division, paragraph (3) - clarification added: "The sponsor of the clinical evaluation must always be the applicant or the future beneficiary (in this case the applicant must be a healthcare facility). Failure to comply with this condition shall be grounds for elimination of the project proposal from the tender".

- See also 4.2 Requirements for the eligibility of the applicant, for the professional competence (if required by the nature of the project) and the method of demonstrating eligibility, paragraph (1)(h), Annex 13 - List of annexes to the project proposal 7) document regulating the relationship of the project to the rules of the SCL

4.2 Requirements for the eligibility of the tenderer, for the professional competence (if required by the nature of the project) and the method of demonstrating eligibility paragraph (1)(h) - deleted: "scan of the letter requesting" and "after receiving this opinion from the SICL, forward it to the provider within 7 days at the latest".

- see further 9.13. Annex 13 - List of annexes to the project proposal 7) document regulating the relationship of the project to the rules of the SÚKL

- summary to SÚKL: in the case of the need for authorisation or notification to SÚKL, the bidder or recipient shall attach a scan of this document, but always at least the opinion of SÚKL, whether or not it is a clinical evaluation within the meaning of Act No. 378/2007 Coll., on pharmaceuticals, while the commissioner of the clinical evaluation must always be the bidder or the future recipient (in this case the bidder must be a health care facility) and therefore it is no longer possible to attach a letter with a request for the opinion of SÚKL!

REGISTRY

3.2.Programme division, paragraph (4) - clarification added: "The creation of such a register cannot therefore be the result and objective of a research project financed from special-purpose support, but can only be its source (a tool and means of solving the project). Individual projects may involve the creation of a database (collection of specific data to be used in the project), but the ultimate aim of the project is to achieve new knowledge.

- We therefore recommend not to include the word "registry" in the project title

MODEL AFFIDAVIT FOR FO AND PO ESTABLISHED OUTSIDE ČR ON PROOF OF ELIGIBILITY

4.2 Eligibility requirements for the tenderer, professional competence (if required by the nature of the project)
and method of demonstrating eligibility paragraph (5) - model added: "(model affidavit is provided in Annex 6 of this tender documentation - see Article 9.6 )".

- See also 9.6.Annex 6 - Model affidavit for proving the eligibility of a tenderer/co-tenderer
based outside the Czech Republic (model Affidavit of the tenderer or co-tenderer*) - natural persons
based outside the Czech Republic on proving eligibility and Affidavit of the tenderer or co-tenderer*) - legal persons based outside the Czech Republic on proving eligibility, further 8. Method of submission of proposals, paragraph (4) and further 9.13. Annex 13 - List of annexes to the project proposal 6) Affidavit for bidders / co-bidders established outside the ČR

EXPECTED RESULTS

5.7.Expected results paragraph (1) in the sentence_Jimp - peer-reviewed journal article with impact factor added: "IF according to SCI/WOS".

- See also 5.7. Expected results paragraph (4)

AFFIDAVITS

9.2. Annex 2 - Model Affidavit of Eligibility, the following sentence is added: "I hereby solemnly declare that the information given in this document is true and correct. I am fully aware that if I make any false statements I will face all the legal consequences arising therefrom.

- further added to the templates: the Affidavit of the Bidder or Co-Bidder* ) - natural persons to prove their competence, the Affidavit of the Bidder or Co-Bidder*) - legal persons to prove their competence, see also Annex 5 - Affidavit of the Bidder in relation to SÚKL and Affidavit of the Bidder - legal persons in relation to SÚKL

ETHICAL COMMISSION

9.7.1 Statement of the bidder's/other participant's ethics committee Paragraph 1 The statement of the bidder's ethics committee must be submitted whenever the project involves the provision of health care, the following has been added: "if it is research with human subjects and also in the case of research with questionnaire methodology and qualitative investigations with persons affected by or at risk of disease in accordance with the International Ethics Committee for Biomedical Research with Human Participants CIOMS/WHO, 2002".

PROJECT OF LESSONS

9.7.2. The Expert Panel Statement - Protection of Experimental Animals has been deleted: "In the event that a valid approved experimental design is not delivered in time for the conclusion of the contract, the MoH will allow a reasonable period of 3 months from the conclusion of the contract to deliver it. The contract shall only become effective upon receipt of all required annexes'.

- will be subsequently adjusted in the contract for the provision of special purpose support for the project

MORE

9.10. Annex 10 - Structure of groups and subgroups of research disciplines for IS R&D&I - CEP - updated according to http://www.vyzkum.cz/FrontClanek.aspx?idsekce=1374.

9.11. Annex 11 - Conditions for project implementation Part 1.1 Procedure for concluding the contract for the provision of special-purpose aid Paragraphs (1) and (2) number of days changed from 30 calendar days to 20 calendar days.

9.11. Annex 11 - Conditions for the solution of projects part 3. Conditions for the handling of special purpose support change of the decree to "Decree of the Ministry of Finance ČR No. 367/2015 Coll.".

9.11. Annex 11 - Project Terms and Conditions, section 4.1 Sub-project and Final Project Report, the following text has been added: "Specifications for completion will be published in the Completion Guidelines on the Provider's website".

9.11. Annex 11 - Project Terms and Conditions Part 4.2 Project Sub-report amended according to GRIS nomenclature.

9.11. Annex 11 - Conditions for project solutions, part 5. Changes during the project solution, paragraph (6) added: "In the event of changes in generally binding legal regulations concerning personnel costs in the project (e.g. changes in salary tariffs, changes in the mandatory allocation to the FKSP, etc.) and their impact on economic indicators, it is possible to make transfers between individual items (from other operating costs to personnel costs) even above the limit of CZK 10 thousand. These transfers can be made up to a maximum of CZK 10 000 without an application and do not require an amendment to the contract or a new decision on the granting of aid. However, the beneficiary must describe and justify these changes in the subsequent report (partial or final).

9.12.4 First Stage evaluation section Economic evaluation in the second stage inserted paragraph: '(4) In the event of the submission of an exceptionally costly project proposal, such proposal may be referred to the Review Board AZV for consideration, which shall assess the adequacy of the proposed recognised costs projected in the proposal for that project'.

9.12.5 Second Level evaluation modified the text of this section.

9.12.6. Third level evaluation modified text of paragraph (4).