Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare (hereinafter called: “Healthcare Facility”) in accordance with applicable legal regulations of the Czech Republic namely Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, Personal Data Processing Act No. 110/2019 Coll., as amended and with Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended, all other applicable laws and regulations including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (Consolidated Guideline and other generally accepted standards of good clinical practice, the terms of the final Protocol (including as it may be amended) provided by Sponsor, an opinion of the Ethics Committee, this Agreement and Sponsor’s guidelines. 1.1 Předmětem této Smlouvy je spolupráce Stran při provádění Studie. Studie bude provedena Hlavním zkoušejícím ve spolupráci s Poskytovatelem zdravotních služeb a musí být provedena ve zdravotnickém zařízení Poskytovatele zdravotních služeb (dále jen „Zdravotnickém zařízení“), a to v souladu s příslušnými právními předpisy České republiky, zejména pak se zákonem č. 378/2007 Sb., o léčivech, ve znění pozdějších předpisů, zákonem č. 372/2011 Sb., o zdravotních službách, ve znění pozdějších předpisů, zákonem č. 110/2019 Sb., o zpracování osobních údajů, v platném znění a vyhláškou č. 226/2008 Sb., o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, ve znění pozdějších předpisů, veškerými dalšími příslušnými zákony a nařízeními, a to včetně Konsolidované směrnice Správná klinická praxe mezinárodní konference pro harmonizaci technických požadavků na registraci léčiv pro humánní použití, podmínkami poslední schválené verze Protokolu (včetně jeho případných dodatků) poskytnuté Zadavatelem, stanoviskem etické komise, touto Smlouvou a pokyny Zadavatele.
Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare (hereinafter called: “Healthcare Facility”) in accordance with applicable legal regulations of the Czech Republic, all other applicable laws and regulations including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (Consolidated Guideline and other generally accepted standards of good clinical practice, the terms of the final Protocol (including as it may be amended) provided by Sponsor, an opinion of the Ethics Committee, this Agreement and Sponsor’s guidelines.
Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare (hereinafter called: “Healthcare Facility”) in accordance with applicable legal regulations of the Czech Republic namely Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, Personal Data Processing Act No. 110/2019 Coll., as amended and with Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended, all other applicable laws and regulations including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (Consolidated Guideline and other generally accepted standards of good clinical practice, the terms of the final Protocol (including as it may be amended) provided by Sponsor, an opinion of the Ethics Committee, this Agreement and Sponsor’s guidelines.
Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare at the Department of Oncology 2nd Medical Faculty, Xxxxxxx University and University Hospital Motol, (hereinafter called: “Healthcare Facility”) led by XXX (hereinafter called: “Principal Investigator”) in accordance with applicable legal regulations of the Czech Republic, all other applicable laws and regulations including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (Consolidated Guideline and other generally accepted standards of good clinical practice, the terms of the final Protocol (including as it may be amended) provided by Sponsor, an opinion of the Ethics Committee, this Agreement and Sponsor’s guidelines.
Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare (hereinafter called: “Healthcare Facility”) in accordance with
Scope of Work Rozsah činnosti. 1.1 The subject of this Agreement is co-operation between the Parties in conducting the Study. The Study is to be performed by Principal Investigator in co-operation with the Provider of Healthcare and shall be performed at healthcare facility of Provider of Healthcare (hereinafter called: “Healthcare Facility”) in accordance with applicable legal regulations of the Czech Republic namely Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, Personal Data Processing Act No. 110/2019 Coll., as amended and with Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended, all other applicable laws and regulations including the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (Consolidated Guideline and other generally accepted standards of good clinical practice, the terms of the final Protocol (including as it may be amended) provided by Sponsor, an opinion of the Ethics Committee, this Agreement and Sponsor’s guidelines.
