Institutional Review Board/Independent Ethics Committee Sample Clauses

Institutional Review Board/Independent Ethics Committee. The Study shall be conducted under the supervision and with the approval of the IRB/IEC. The Site shall conduct the Study only after its IRB/IEC has approved the Protocol, Informed Consent form, and subject recruitment documents, as applicable, and any amendments to the foregoing, in writing and a copy of these approvals has been received by Sponsor. In the event of any amendment to the Protocol that requires IRB/IEC review, continuation of the Study at the Institution is subject to IRB/IEC approval of the amendment. své povinnosti podle této smlouvy, může poskytovatel zdravotních služeb jmenovat náhradníka za hlavního zkoušejícího. Zadavatel může dle vlastního uvážení tohoto náhradníka schválit nebo zamítnout. V případě, že takový náhradník není schválen, si zadavatel vyhrazuje právo ukončit smlouvu v souladu s článkem 12 této smlouvy. 2.4. Vlastnictví, dodávka a vrácení hodnoceného léčivého přípravku a manipulace s ním. Zadavatel je a vždy zůstává výhradním vlastníkem hodnoceného léčivého přípravku, který je uveden výše a je poskytnut v rámci této smlouvy. Zadavatel zdarma poskytne pracovišti potřebné množství hodnoceného léčivého přípravku, a to pro účely provádění studie na pracovišti. Pracoviště bude s hodnoceným léčivým přípravkem manipulovat a bude jej uchovávat v souladu s protokolem, studijními dokumenty a všemi příslušnými zákony a předpisy a po ukončení studie vrátí veškeré nepoužité hodnocené léčivé přípravky zadavateli nebo CRO na náklady zadavatele nebo zlikviduje všechny nevyužité části hodnocených léčivých přípravků v souladu s písemnými pokyny zadavatele. Pracoviště bude uchovávat záznamy o přijetí a vydání hodnoceného léčivého přípravku, a to včetně dat, množství a použití pacienty. Všechny prázdné obaly od hodnocených léčivých přípravků budou uchovány a vráceny zadavateli nebo CRO na náklady zadavatele, pokud o to zadavatel požádá. 2.5. Institucionální hodnotící komise / nezávislá etická komise. Studie bude provedena pod dohledem IRB/EK a s jejich souhlasem. Pracoviště bude provádět studii pouze poté, co IRB/EK písemně schválí protokol, formulář informovaného souhlasu a příslušné dokumenty k náboru subjektů a případné změny výše uvedených dokumentů, a poté, co zadavatel obdrží kopie takových schválení. V případě jakýchkoli změn protokolu, které vyžadují přezkum IRB/EK, bude pokračování studie u poskytovatele zdravotních služeb podléhat schválení změn ze strany IRB/EK.
Sample 1
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Institutional Review Board/Independent Ethics Committee. Before the Trial is initiated, INC Research 3. Institucionální hodnoticí komise/nezávislá etická komise. Než je hodnocení zahájeno, zajistí INC will ensure that both the Trial and the informed consent form are approved by an IRB/IEC and competent regulatory authority (State Institute for Drug Control – SÚKL) and comply with all applicable regulations. INC Research and Sponsor shall comply with all applicable legal requirements in relation to SÚKL and competent ethics committees, or another regulatory authorities, if applicable, including notification of the Trial initiation and termination, submission of reports, reporting of adverse reactions, notification of new circumstances and corresponding measures, approval of informed consent form and its modifications, approval of Protocol Amendments. Research, že jak hodnocení, tak i formulář informovaného souhlasu budou schváleny IRB/EK a příslušným regulačním úřadem (Státním ústavem pro kontrolu léčiv – SÚKL) a vyhovují všem platným právním předpisům. INC Reseach odpovídá za plnění zákonných povinností ve vztahu k SÚKL a etickým komisím, případně k jiným regulačním úřadům, a to včetně ohlášení zahájení a ukončení hodnocení, podávání zpráv a hlášení nežádoucích účinků, oznámení nových skutečností a přijatých opatření a dalších informačních povinností, schválení informovaného souhlasu a jeho změn, schválení dodatků k Protokolu.
Sample 1
Institutional Review Board/Independent Ethics Committee. A copy of the protocol, proposed informed consent form, other written subject information, and any proposed advertising material must be submitted to the IRB / IEC for written approval. A copy of the written approval of the protocol and informed consent form must be received before recruitment of participants into the study and shipment of Opthea investigational product (OPT-302). The investigator must submit and, where necessary, obtain approval from the IRB / IEC for all subsequent protocol amendments and changes to the informed consent document. The investigator should notify the IRB / IEC of important deviations from the protocol or SAEs occurring at the site and other AE reports received from Opthea, in accordance with local procedures. The investigator will be responsible for obtaining annual IRB / IEC approval /renewal throughout the duration of the study. The investigator must also notify the IRB / IEC of the end of the study.
Sample 1
Institutional Review Board/Independent Ethics Committee. Each study shall be conducted under the supervision and with the approval of the IRB/IEC. Institution and Principal Investigator shall conduct the study only after its IRB/IEC has approved the Protocol, Informed Consent, and Study Patient recruitment documents, as applicable, and any amendments to the foregoing, in writing and a copy of these approvals has been received by Sponsor. In the event of any amendment to a Protocol Agreement that requires IRB/IEC review, continuation of the study at the Institution is subject to IRB/IEC approval of the amendment. Sponsor reserves the right to terminate any Protocol Agreement in accordance with Article 13 herein if IRB/IEC does not approve such amendment. Principal Investigator shall keep the IRB/IEC fully informed of the progress of each study. Institution and Principal Investigator shall forward to Sponsor copies of all correspondence to or from the IRB/IEC concerning each study and shall notify Sponsor of any refusal of, withdrawal of, or suspension of IRB/IEC approval within twenty-four (24) hours of receiving such notification. For sake of clarity, use of the phrase "IRB/IEC" here and throughout this Master Agreement means "IRB and/or IEC (if applicable)". Principal Investigator shall obtain continuing review and approval of each study from the IRB and/or IEC (if applicable) including but not limited to submission of information regarding adverse events and amendments to the Protocol Agreement. Principal Investigator shall submit copies of continuing approvals to Sponsor. Institution and Principal Investigator shall submit an annual report to the IRB and/or IEC regarding each study with a copy to Sponsor. 2.8.
Sample 1

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