Obligations of Provider and Principal Investigator. Provider and Principal Investigator will ensure that Research Staff is informed of and agree to abide by all terms of this Agreement applicable to the activities they perform. Provider and Principal Investigator will assume all those responsibilities assigned under all applicable laws, including but not limited to the laws on clinical trials of medicinal products, confidentiality and personal data safety and protection of Trial Subject information, including the 1.3.
Obligations of Provider and Principal Investigator. Provider and Principal Investigator are responsible to Sponsor for compliance by all Trial personnel with the terms of this Agreement. Provider and Principal Investigator will ensure that only Provider employees assist in the conduct of the Trial (hereinafter “Collaborators”) and that such Collaborators are informed of and agree to abide by all terms of this Agreement applicable to the activities they perform. Provider will determine which of the obligations in this Agreement it will delegate to Principal Investigator. Provider and Principal Investigator will assume all those responsibilities assigned under all applicable laws especially Act. Xx. 000/0000 Xxxx. Xxxxxxxxxxxxxx Xxx, Xxx No. 372/2011 Coll. Health Services Act, Act No. 101/2000 Coll. Private Personal Data Act, Regulation of the European Parliament and the Counsil No. 679/2016 (GDPR) and Decree No. 226/2008 Coll. on good clinical practice, rules, regulations, guidelines and standards including without limitation all relevant International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines and standards, and the World Medical Association declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects” (1996), all applicable laws and guidance relating to clinical trials of medicines and all applicable laws relating to human rights, supply of medicines legislation, legislation relating to human tissue and biological samples and all applicable laws relating to the confidentiality, privacy and security of patient information (“Applicable Law”). pneumonie, ventilátorové pneumonie nebo bakteriální pneumonie související se zdravotní péčí, způsobené gramnegativními patogeny“ (dále jen “protokol”), které bude prováděno v prostorách poskytovatele zdravotních služeb a zašazoval do něj subjekty klinického hodnocení (souhrnně dále jen „klinické hodnocení“). Strany se dohodly takto: 1.
Obligations of Provider and Principal Investigator. Provider and Principal Investigator will ensure that any personnel who assist in the conduct of the Trial are informed of and agree to abide by all terms of this Agreement applicable to the activities they perform. Provider and Principal Investigator will assume all those responsibilities assigned under all applicable laws, rules, regulations, guidelines and standards including without limitation all relevant International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines and standards and the World Medical Association declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects” (1996), all applicable laws and guidance relating to clinical trials of medicines and all applicable laws relating to human rights, supply of medicines legislation, legislation relating to human tissue and biological samples, the 1.2.
Obligations of Provider and Principal Investigator. Provider and Principal Investigator will ensure that Collaborators is informed of and agree to abide by all terms of this Agreement applicable to the activities they perform. Provider and Principal Investigator will assume all those responsibilities assigned under all applicable laws, rules, regulations, guidelines and standards including, without limitation, all relevant International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines and standards and the World Medical Association declaration of Helsinki “Ethical Principles for Medical Research Involving Human Subjects” (2013), and relevant law, regulations and government guidelines, including Act No. 378/2007 Coll., on Pharmaceuticals, as amendmed, Decree of the Ministry of Health and Ministry of Agriculture No. 226/2008 Coll., on Good Clinical Practice and Closer Clinical Trial Conditions on medicinal products, as amended, Decree of the Ministry of Health and Ministry of Agriculture No. 86/2008 Coll., on establishing principles of Good Laboratory Practice in the area of Pharmaceuticals, as amended, Decree of the Ministry of Health and Ministry of Agriculture No. 84/2008 Coll., on Good Pharmacy Practice, Detailed Conditions of Treatment of Drugs in Pharmacies, Medical Facilities and Other Operators and Facilities Issuing Medicinal Products, as amended, and Act No. 372/2011 Coll., on Health Services and Conditions for their Provisions, as amended regulations and all applicable laws relating to the confidentiality, privacy and security of Trial Subject information inclusive but not limited to the EU General Data Protection Regulation - GDPR (“Applicable Law”). 1.3.
Obligations of Provider and Principal Investigator. Provider and Principal Investigator will ensure that any Trial Team members who assist in the conduct of the Trial are informed of and abide by all terms of this Agreement applicable to the activities they perform. Provider and Principal Investigator will smlouvy č. HHSO100201700014C. Podmínkou finanční podpory úřadu BARDA je možnost účasti BARDA při návštěvách a auditech společnosti Syneos Health a zadavatele na pracovištích (včetně návštěv zařízení společnosti Syneos Health) a kontroly záznamů klinického hodnocení. Zadavatel si přeje, aby poskytovatel zdravotních služeb provedl klinické hodnocení hodnoceného léčivého přípravku (definovaného níže) ridinilazol/ SMT19969, s kódovým označením SMT19969/C005, nazvané „Randomizované, dvojitě zaslepené, aktivně kontrolované klinické hodnocení fáze III porovnávající účinnost a bezpečnost ridinilazolu (200 mg, dvakrát denně) po dobu 10 dní s vankomycinem (125 mg, čtyřikrát denně) xx xxxx 00 xxx xxx xxxxx infekce Clostridium difficile (CDI) (dále jen “Protokol”), které bude prováděno v prostorách Poskytovatele zdravotních služeb (dále jen “Klinické Hodnocení”) a zařazoval do něj pacienty (dále jen “Subjekty Klinického Hodnocení”). Strany se dohodly takto: 1. Zkoušející a Spolupracující osoby. 1.1.
