EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator 1.5
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Partieswill obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Gilead or CRO will provide ICF template and Institution and Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Any proposed deviations by Institution from Xxxxxx’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach of this Agreement. 1.7
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Sponsor will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Sponsor will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Institution or Investigator will promptly supply Gilead or CRO with appropriate evidence of EC approval, a copy of the EC- approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Institution. Any proposed deviations by Institution from Xxxxxx’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach of this Agreement. The Sponsor prepared and handed over to the Principal Investigator a draft form of the written trial Subject Informed Consent to participate in the Study, which will include information for trial Subjects (regarding the nature, significance, implications and risks of the Study). A sample informed consent is attached to this Agreement. 1.6
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain Ethics Committee (EC) approval documentation for the Trial from Gilead or CRO, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Gilead in collaboration with CRO will ensure that the ICF complies in form and Institution and Investigator shall ensure the content and completion of the ICF, specific to each Trial Subject complies with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Gilead or CRO will promptly supply Institution or Investigator with appropriate vztah s Institucí; nebo (v) jakkoli jinak xx xxxxx nevhodným, neschopným nebo neochotným plnit své závazky xxxx xxxxx Smlouvou. V případě jakéhokoliv z (i)-(iii) a (v) bude původní Zkoušející i nadále dodržovat podmínky této Smlouvy, a v případě (iv) původní Zkoušející souhlasí s xxx, že bude dodržovat své povinnosti, pokračovat v plnění podmínek této Smlouvy, včetně povinností mlčenlivosti uvedených v části 4 a závazků vlastnictví stanovených v části 6. Na požádání společnosti Gilead budou Instituce a původní Zkoušející spolupracovat při hledání vhodného náhradního zkoušejícího nebo převodu Studie do jiné instituce v brzkém termínu tak, aby se Studie nepřerušila.
EC Approvals and Informed Consent Form. Prior to the commencement of the Study, Institution will obtain approval for the Study, including approval of the Protocol, Sponsor’s informed consent form and, if applicable, pediatric assent form (collectively, “ICF”), and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Study, a properly executed ICF, as approved by Sponsor and the EC before such individual is allowed to be screened for participation in the Study. Institution or Investigator will promptly supply Sponsor with
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Institution or Investigator will promptly supply Gilead or CRO with appropriate evidence of EC approval, a copy of the EC-approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Institution. Any proposed deviations by Institution from Gilead’s model ICF language must be approved by Gilead in advance of any use with subjects in the Trial. Breach of this Section 1.5 will constitute a material breach 1.5 Modulo di consenso informato e Approvazioni del CE. Prima dell’inizio della Sperimentazione presso il Centro della sperimentazione, l’Istituto otterrà l’approvazione per la Sperimentazione, compresa l’approvazione del Protocollo, il modulo di consenso informato e, se pertinente, il modulo di consenso pediatrico (chiamati complessivamente “ICF”), e qualsivoglia emendamento agli stessi, dal Comitato etico interessato (“CE”), in conformità alle leggi, regole e normative applicabili. L’Istituto e lo Sperimentatore otterranno da ciascun individuo (o dal rappresentante legale di ciascun individuo), che debba essere sottoposto a screening per la partecipazione alla Sperimentazione, un ICF debitamente sottoscritto, come approvato da Gilead e dal CE, prima che la partecipazione alla Sperimentazione di tale candidato sia vagliata. L’Istituto o lo Sperimentatore garantirà che l’ICF sia conforme, in forma e contenuto, alle leggi, normative e direttive vigenti, tra cui l’ICH-GCP e le leggi che governano la protezione dei dati e la privacy, oltre che ai relativi termini del Protocollo. L’Istituto o lo Sperimentatore fornirà prontamente a Gile...
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly odůvodnění do dvaceti čtyř (24) hodin po jejím vzniku a do pěti (5) pracovních dnů po výskytu takového odchýlení podá společnosti Gilead písemnou zprávu. 1.3 Dodržení podmínek ze strany Zkoušejícího. Instituce a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a xxxx zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy. 1.4
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened takového odchýlení podá společnosti Gilead písemnou zprávu. 1.3 Dodržení podmínek ze strany Zkoušejícího. Instituce a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a xxxx zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy. 1.4
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Provider and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Provider and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Sponsor and the EC before such individual is allowed to be screened for participation in the Trial. Provider or Investigator will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all relevant terms of the Protocol. Provider or Investigator will promptly supply Sponsor or CRO with appropriate evidence of EC approval, a copy of the EC-approved ICF, and any amendments to the ICF later approved by the EC prior to its use by Provider. Any proposed deviations by Provider from Sponsor’s model ICF language must be approved by
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be společnost Gilead ústně o takové odchylce a a její odůvodnění do dvaceti čtyř (24) hodin po jejím vzniku a do pěti (5) pracovních dnů po výskytu takového odchýlení podá společnosti Gilead písemnou zprávu. 1.3 D održení podmínek ze strany Zkoušejícího. Instituce a Zkoušející tímto prohlašuje, že Zkoušející je jejím zaměstnancem a že podepsal podpisovou stranu Protokolu i této Smlouvy, a xxxx zaručuje, že Zkoušející bude dodržovat veškeré podmínky Protokolu a této Smlouvy. 1.4 Z astavení činnosti, omezení nebo neschopnost Zkoušejícího. Instituce a Zkoušející bezodkladně písemně uvědomí společnost Gilead, pokud v průběhu Studie: (i) bude Zkoušejícímu zastavena činnost, ztratí svou kvalifikaci nebo obdrží oznámení o jakémkoli vyšetřování ze strany jeho profesionální vedoucí organizace, jakéhokoli regulačního orgánu nebo jiné vládní organizace; (ii) Zkoušející obdrží oznámení o jakémkoli omezení svých klinických privilegií v Instituci; (iii) Zkoušející je sankcionován jakýmkoli regulačním orgánem nebo jinou vládní organizací; (iv) ukončí xxxx xx mu ukončen pracovní poměr nebo jiný smluvní vztah s Institucí; nebo (v) jakkoli jinak xx xxxxx nevhodným, neschopným nebo neochotným plnit své závazky xxxx xxxxx Smlouvou. V případě kterékoli výše popsané situace Instituce zajistí, aby Zkoušející nadále dodržoval podmínky této Smlouvy. Na požádání společnosti Gilead budou Instituce a Zkoušející spolupracovat xxx xxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxxxx nebo převodu Studie do jiné instituce v brzkém termínu tak, aby se Studie nepřerušila. 1.5
