Obligations of Institution and Principal Investigator. Institution 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. Institution 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), all applicable laws and guidance relating to clinical trials of medicines and all applicable laws 1.
Obligations of Institution and Principal Investigator. Institution and Principal Investigator undertake to Sponsor to comply with the terms of this Agreement and Principal Investigator shall ensure that all Trial Personnel comply with this Agreement.Institution and Principal Investigator will ensure that any Trial 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. Institution will determine which of the obligations in this Agreement it will delegate to Principal Investigator. Institution 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 and all applicable laws relating to the confidentiality, privacy and security of patient information (“Applicable Law”). Povinnosti zdravotnického zařízení a hlavního zkoušejícího Zdravotnické zařízení a hlavní zkoušející se zavazují dodržovat podmínky smlouvy a hlavní zkoušející zajistí, že veškerý personál klinického hodnocení bude dodržovat podmínky této smlouvy. Zdravotnické zařízení a hlavní zkoušející zajistí, aby personál, který se bude podílet na provádění klinického hodnocení, byl informován o veškerých podmínkách této smlouvy platných pro vykonávané činnosti a souhlasil s nimi. Zdravotnické zařízení určí, které povinnosti stanovené v této smlouvě deleguje na hlavního zkoušejícího. Zdravotnické zařízení a hlavní zkoušející převezme všechny povinnosti vyplývající ze všech platných zákonů, předpisů, pokynů a norem, včetně zejména všech platných pokynů a standardů Mezinárodní konference o harmonizaci správné klinické praxe (International Conference on Harmonization Good Clinical Practice, ICH GCP) a Helsinské deklarace Světové lékařské asociace “Etické zásady pro lékařský výzkum za účasti lidských subjektů” (1996), všech platných zákonů a pokynů upravujících klinická hodnocení léčivých přípravků a všech platných zákonů upravujících lidská práva, legislativy upravující dodávky léků, legi...
Obligations of Institution and Principal Investigator. Institution 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. Institution 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), 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 Trial Subject information inclusive but not limited to the EU General Data Protection Regulation - GDPR(“Applicable Law”).
Obligations of Institution and Principal Investigator. Povinnosti zdravotnického zařízení a hlavního zkoušejícího
Obligations of Institution and Principal Investigator. Institution 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. Institution 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 including without limitation, Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Medical Services, as amended, and Regulation No. 226/2008 Coll., Specifying the Good Clinical Practice and Stipulating the Detailed Conditions of the Clinical Trial and all applicable laws relating to human rights, supply of medicines legislation, legislation relating to human tissue and biological samples, the confidentiality, privacy and security of patient information including without limitation, Act No. 101/2000 Coll., on Personal Data Protection, as amended (implementing the the EU Data Protection Directive 95/46/EC) (“Applicable Law”).
Obligations of Institution and Principal Investigator. Institution and Principal Investigator will ensure that Research Staff is informed of and agree to abide by all terms of this Agreement 1.
Obligations of Institution and Principal Investigator. Institution and Principal Investigator are responsible to Sponsor for compliance by all Research Staff with the terms of this Agreement. Institution and Principal Investigator will ensure that all Research Staff are informed of and agree to abide by all terms of this Agreement applicable to the activities they perform. Institution will determine which of the obligations in this Agreement it will delegate to Principal Investigator.
Obligations of Institution and Principal Investigator. Institution and Principal Investigator are responsible to Sponsor for compliance by all Trial personnel with the terms of this Agreement. Institution 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. Institution will determine which of the obligations in this Agreement it will delegate to Principal Investigator. Institution and Principal Investigator will assume all those responsibilities assigned under all applicable laws, rules, regulations of Czech Republic, 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 of Czech Republic relating to clinical trials of medicines and all applicable laws of Czech republic relating to human rights, supply of medicines legislation, legislation relating to human tissue and biological samples and all applicable laws of Czech Republic relating to the confidentiality, privacy and security of patient information (“Applicable Law”).
Obligations of Institution and Principal Investigator. Institution and Principal Investigator are responsible to Sponsor for compliance by all Trial personnel with the terms of this Agreement. Institution 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. Institution will determine which of the obligations in this Agreement it will delegate to Principal Investigator. Institution and Principal Investigator will assume all those responsibilities assigned under all applicable laws, in particular Czech Act on Pharmaceuticals No. 378/2007 Coll., Health Services Act No. 372/2011 Coll. and Degree 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 all applicable laws relating to the confidentiality, privacy and security of patient information, particularly Act No. 101/2000 Coll. Personal data protection ("Applicable Law").
Obligations of Institution and Principal Investigator. Institution and Principal Investigator are responsible to Sponsor for compliance by all Trial personnel with the terms of this Agreement. Institution 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. Institution will determine which of the obligations in this Agreement it will delegate to Principal Investigator. Institution 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 all applicable laws relating to the confidentiality, privacy and security of patient information (“Applicable Law”).
