Scope of Work and Cyber Security Rozsah činnosti a kybernetická bezpečnost. 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. 1.1 Předmětem této Smlouvy je spolupráce Xxxxx 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, 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 and Cyber Security Rozsah činnosti a kybernetická bezpečnost. 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.
