The Contracting Partners certify and warrant that they are not the subject of any past or pending governmental or regulatory investigation, inquiry, warning, or enforcement action (hereinafter collectively referred to as “Competent Authority Action”) related to their conduct of clinical trials that has not been disclosed to Novartis. The Contracting Partners will notify Novartis promptly if it receives notice of or becomes the subject of any Competent Authority Action regarding their compliance with ethical, scientific, or regulatory standards for the conduct of clinical trials, if the Competent Authority Action relates to events or activities that occurred prior to or during the period in which the Clinical Trial under this Agreement was conducted.
The Contracting Partners shall conduct and document the Clinical Trial in a diligent and efficient manner in strict compliance with (a) the Protocol; and (b) the terms and conditions of this Agreement; and (c) the ethical principles of the Declaration of Helsinki; and (d) the ICH Harmonised Tripartite Guideline for Good Clinical Practice as amended from time to time as well as generally accepted standards of Good Clinical Practice; and (e) all applicable legal regulations; and (f) all approvals/permits, orders and directives of competent public administration authorities, health insurance companies and ethics committees, if any; (g) an instruction issued by Novartis entitled “Investigator’s Brochure”, which contains all currently known information on the Medicinal Product used in the Clinical Trial and on its properties. Novartis provided the Principal Investigator with the Brochure and shall periodically update the Brochure as required by the status of the Clinical Trial or set out in the legal regulations. The Brochure will be appended to the Clinical Trial documents;
The Contracting Partners agree to immediately answer any questions of Novartis or persons authorized by Novartis regarding adverse event documentation. This includes - but is not limited to - active follow-up monitoring and clarification of relevant inconsistencies in adverse event and pregnancy reports. For the purposes of adverse event and pregnancy reporting, the Contracting Partners must use the forms provided by Novartis, if applicable.
The Contracting Partners agree to indemnify Novartis for any damage (including non-pecuniary damage and death of Trial Subject) incurred as a result of (i) a negligent or willful illegal act or omission and/or (ii) a breach of any obligations assumed under this Agreement as well as (iii) breach of legal regulations by either of them or any employee of the Center or contractors used for the purposes of fulfilment of this Agreement. Claim for damages does not arise, or arises only in a proportional amount, if health-related harm (including death) occurred due to the fault or spôsobená zavinením či spoluzavinením subjektu skúšania či jeho zákonného zástupcu, čo aj z nedbanlivosti. contributory fault of the Trial Subject or his/her legal representative, also due to negligence.
The Contracting Partners understand that Novartis may disclose on the central website of the xxx.xxxxxxxx.xx group any payment and any transfer of value relating to research and development, i.e. (1) payments made by Novartis under this Agreement and (2) any cost of accommodation, refreshments and travel of the Contracting Partners, which Novartis covers under this Agreement and
The Contracting Partners agree to include in every Publication information that the creation of data was supported by Novartis as well as information about their involvement in the Clinical Trial and their benefits from the Clinical Trial. Authorship and acknowledgements for scientific publications should be consistent with the Uniform Requirements for Manuscripts issued by the International Committee of Medical Journal Editors (ICMJE). Any such Publication or disclosure must comply with all applicable laws and must be limited to scientific findings. Without prejudice to the first sentence of this paragraph, Publication or disclosure must, in particular, not constitute promotion under the applicable laws. All persons must therefore fulfill all four ICMJE authorship criteria during publication development to be included as authors on the publication, as follows:
The Contracting Partners agree to impose the same obligations and requirements for publications as set forth in Article 6.11 Chyba! Nenašiel sa žiaden zdroj odkazov. on Investigators and all Clinical Trial Team Members.
The Contracting Partners agree to indemnify Novartis for any damage (including non-pecuniary damage and death of Trial Subject) incurred as a result of (i) a negligent or willful illegal act or omission and/or (ii) a breach of any obligations assumed under this Agreement as well as (iii) breach of legal regulations by either of them or any employee of the Center or contractors used for the purposes of fulfilment of this Agreement. Claim for damages does not arise, or arises only in a proportional amount, if health-related harm (including death) occurred due to the fault or contributory fault of the Trial Subject or his/her legal representative, also due to negligence.
The Contracting Partners represent and undertake that they shall ensure the possibility of the unblinding of Trial Subjects in the course of the Clinical Trial under the Protocol and this Agreement at any time, that means 24 hours a day, 7 days a week, as required by the Protocol. For this purpose, they shall provide Trial Subjects with telephone contacts to the Principal Investigator and to the relevant Clinical Trial Team Members, with at least one of these persons being available on these telephone numbers 24 hours a day, 7 days a week.
The Contracting Partners agree to include in every Publication information that the creation of data was supported by Novartis as well as information about their involvement in the Clinical Trial and their benefits from the Clinical Trial. Authorship and acknowledgements for scientific publications should be consistent with the Uniform Requirements for Manuscripts issued by the International Committee of Medical Journal Editors (ICMJE). Any such Publication or disclosure must comply with all applicable laws and must be limited to scientific findings. Without prejudice to the first sentence of this paragraph, Publication or disclosure must, in particular, not constitute promotion under the applicable laws. All persons must therefore fulfill all four ICMJE authorship criteria during publication development to be included as authors on the publication, as follows: a) substantial contributed to conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; and b) drafted the work or revising it critically for important intellectual content; and c) approved the final version to be published; and d) agreed to take all responsibility for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
