Conduct of the Study. (a) Study will be performed at Institution and/or Investigator shall ensure that all persons who have involvement in the Study and who are employees, independent contractors or agents of Institution, including but not limited to pharmacy, laboratory, radiology, pathology, cardiology and nursing staff (hereinafter „Research Staff”) have the knowledge and experience to undertake the Study and shall (i) accurately, efficiently and expeditiously perform the Study in a professional and competent manner and (ii) document and report Study activities in an accurate, timely and complete manner. Institution and Investigator shall ensure that each member of the Research Staff shall have given a written data protection consent in accordance with Section 5 of this Agreement before commencing his or her work on the Study, and shall provide the completed consent forms to Xxxxxxxx or Sponsor upon request. Wherever, in this Agreement, reference is made to obligations which are incumbent on the Institution and/or Investigator for services which may be performed by Research Staff, such reference is intended to include Research Staff. (b) Institution and Investigator shall each conduct the Study in accordance with (i) written instructions from Sponsor or Xxxxxxxx (“Instructions”), (ii) the Protocol, this Agreement, relevant professional standards of medical practice, (iii) all applicable international and country state laws, guidelines, rules and regulations, applicable privacy laws, rules and regulations and ICH-GCP Guidelines (CPMP/ICH/135/95) (“Applicable Law”) and (iv) the terms of the approval for the Study from the respective ethics committee empowered by Applicable Law to review the Study (“Ethics Committee”). Jelikož, Zkoušející, zaměstnanec Zdravotnického zařízení, má znalosti a zkušenosti k provedení Studie a společnost Xxxxxxxx si přeje zadat Zdravotnickému zařízení a Zkoušejícímu provedení Studie. Jelikož, Zdravotnické zařízení a Zkoušející se chtějí podílet na provádění Studie; se proto nyní Smluvní strany dohodly takto: 1. PROVEDENÍ STUDIE (a) Studie bude probíhat na pracovišti Zdravotnické zařízení a/nebo Zkoušející zajistí, aby všechny osoby účastnící se Studie, které jsou zaměstnanci, nezávislými dodavateli nebo zástupci Zdravotnického zařízení, zejména pracovníci lékárny, laboratoře, radiologie, patologie či kardiologie a zdravotnický personál (dále jen "Výzkumný personál") mají znalosti a zkušenosti k provedení Studie a provedou Studii (i) přesně, rychle a ...
Conduct of the Study. The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.
Conduct of the Study. 2.1 Institution agrees, and commits itself to CRO, to allow Investigator and other Study Personnel to conduct the Study at Institution, and warrants that Investigator and other Study Personnel are employed by Institution.
Conduct of the Study. Company is managing the Study entitled, “Update of antimicrobial spectrum and potency of dalbavancin and other antibiotics tested in clinical isolates of Gram-positive pathogens from southern and central Europe and Russia” (“Study. Institution will ensure that the Investigator and all Study personnel will perform the Study in accordance with the Study protocol number 146PO16289 (including any subsequent amendments), attached hereto as Exhibit A (“Protocol”) and incorporated herein by reference. Institution and Investigator will ensure that all data provided is accurate and complete. The 1. Provádění studie. Společnost řídí studii s názvem „Aktualizace antimikrobiálního spektra a účinnosti dalbavancinu a dalších antibiotik testovaných na klinických izolátech grampozitivních patogenů z jižní a střední Evropy a Ruska“ (dále jen „studie“). Zdravotnické zařízení zajistí, že zkoušející a veškerý personál klinického hodnocení budou provádět klinické hodnocení v souladu s protokolem klinického hodnocení číslo 146PO16289 (včetně případných následných dodatků), který je připojen k této smlouvě jako příloha A (dále jen „protokol“) a je do ní začleněn prostřednictvím odkazu. Zdravotnické zařízení a zkoušející zajistí, že parties will comply with all applicable laws and regulations relating to the conduct of the Study, including those related to the conduct of microbiological research, data privacy, financial disclosure, conflict of interest, anti-bribery and anti-corruption (“Applicable Law”). Institution also will maintain any licenses, permits or registrations required to perform the Study. veškeré poskytnuté údaje jsou přesné a úplné. Smluvní strany budou dodržovat všechny platné zákony a předpisy vztahující se k provádění této studie, včetně zákonů a předpisů souvisejících s prováděním mikrobiologického výzkumu, ochranou osobních údajů, poskytováním finančních informací, střetem zájmů a zákonů proti úplatkářství a korupci (dále jen „platné právní předpisy“). Zdravotnické zařízení bude udržovat všechny licence, povolení nebo registrace požadované pro provádění tohoto klinického hodnocení.
Conduct of the Study. The parties agree to conduct the Study based upon the terms and conditions contained in this Agreement and in accordance with the Protocol attached as Appendix A.
Conduct of the Study. The Institution, through the applicable Principal Investigator and Sub- investigators, shall conduct each Study in accordance with this Agreement, the applicable SOW, the applicable Protocol, and the applicable investigator’s brochure for the Protocol (the “Investigator’s Brochure”), as each may be amended, and all applicable laws, rules, regulations and guidelines, as adopted into law relating to the conduct of clinical investigations, good clinical practice (GCP) principles, generally accepted medical practice, and applicable export control rules and regulations (collectively, “Applicable Laws”). For purposes of this Agreement, the term “Institution” shall include all employees, executives, officers, directors, faculty, staff and other authorized agents of the Institution. SPONSOR will use reasonable efforts to perform its applicable obligations in connection with each Study including, but not limited to, monitoring visits.
Conduct of the Study. The parties to the attached agreement (the “Agreement”) and agree that the clinical trial described therein (the “Study”) will be performed in strict accordance with the applicable protocol, and any subsequent amendments thereto (the “Protocol”), laws, regulations and guidelines applicable in the Czech Republic, and good clinical practices (“GCPs”) including without limitation applicable guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and in particular Act No 378/2007 Coll., on pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) and Decree No 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended and Act No. 372/2011 Coll., on Providing Medical Services, as amended. The Principal Investigator (the “Principal Investigator”) shall review all case report forms (“CRFs”) to ensure their accuracy and completeness, shall review and understand the information in the Principal Investigator’s brochure or device labeling instructions as applicable.. Site agrees to ensure that all clinical data are accurate, complete, and legible. The Site shall promptly and fully produce all data, records and information relating to the Study to PRA and to Sponsor and their representatives during normal business hours, and shall assist them in promptly resolving any questions and in performing audits or reviews of original subject records, reports, or data sources. The Site shall keep PRA informed about the progress of the Study, shall inform PRA immediately of any deviations from the Protocol, and document and certify to such deviations and report adverse events in accordance with the provisions of the Protocol. The Site agrees to cooperate with the representatives of PRA and Sponsor who visit the Institution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for, such representatives. The Site shall retain, use and transfer blood, fluid and tissue samples (“Biological Samples”) from Subjects, including any tangible materials derived from such Biological Samples) only in accordance with the Protocol and the applicable informed consent form and shall not collect or reserve additional PŘÍLOHA A PODMÍNKY
Conduct of the Study. 1.1. Compliance with Laws, Regulations, and Good Clinical Practices Institution agrees that Institution and Study Staff shall perform the Study at Institution in strict accordance with this Agreement, the Protocol, any and all applicable local, national and international laws, regulations and guidelines, including in particular, but without limitation, GCPs, Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to some related acts (“Act on Pharmaceuticals”) and Decree No. 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended, Act No. 372/2011 Coll., on Medical Services and terms and conditions of performance of such services („Act on Medical Services“) or any subsequent amendments or laws substantially replacing any of the na základě samostatné smlouvy uzavřené mezi Quintiles a Zadavatelem. Služby Quintiles zahrnují monitoring Studie a uzavírání smluv s klinickými výzkumnými centry VZHLEDEM K TOMU, že Poskytovatel a Zkoušející (dále společně jen „Místo provádění klinického hodnocení”) hodlají provést Studii a Quintiles po Poskytovateli požaduje provedení takové Studie. VZHLEDEM K TOMU, že Poskytovatel a Zkoušející souhlasí s tím, aby společnost Quintiles plnila veškeré závazky Zadavatele jakožto zadavatele klinického hodnocení, jejichž plněním bude pověřena, a uplatňovala veškerá práva Zadavatele, jejichž uplatňováním bude pověřena. VZHLEDEM K TOMU, že tato Xxxxxxx neupravuje ujednání mezi Zadavatelem, Quintiles a Zkoušejícím, a mezi Zadavatelem, Quintiles a Zkoušejícím bude uzavřena samostatná smlouva o provedení klinického hodnocení léčiv, na základě které bude Zkoušející odměněn za provedení této Studie. NYNÍ S OHLEDEM NA SHORA UVEDENÉ, bylo dohodnuto následující:
Conduct of the Study. The Parties shall conduct the Study in accordance with this Agreement, the Protocol, all reasonable written instructions of the Sponsor, and all applicable laws and regulations, including, without limitation, any applicable requirements of the European Medicines Agency (“EMA”) and the International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines, 1.2 Provádění studie. Smluvní strany budou studii provádět v souladu s touto smlouvou, protokolem, všemi odpovídajícími písemnými pokyny zadavatele a všemi příslušnými zákony a předpisy, zejména veškerými příslušnými požadavky Evropské lékové agentury (European Medicines Agency, „EMA“) a směrnicemi Mezinárodní konference pro harmonizaci upravujících správnou (“Applicable Law”). The Institution shall refrain from, and shall cause the Principal Investigator as well as the entire Study team (“Study Staff”) to refrain from using the Investigational Drug in any manner that is contrary to the provisions of, or outside the scope of, the Protocol or that is contrary to Sponsor’s written instructions. The Institution and Principal Investigator shall be entitled to refuse fulfilling the instructions by the Sponsor and shall not be duty-bound to fulfil these instructions, if they are in conflict with the law, the Protocol, authorization from Státní ústav pro kontrolu léčiv (SÚKL) or favourable opinion of the relevant ethics committees, good clinical practice, or if it can be reasonably assumed that fulfilling the instructions would constitute a disproportionate increase in health risk for Study Subjects or risk of property damage to the Institution, or it can be reasonably be assumed that this fulfilment would lead to the costs to the Institution not anticipated in this Agreement, or the fulfilment of these conditions is feasible for the Institution only with disproportionate difficulties klinickou praxi (International Conference on Harmonization Good Clinical Practice, „ICH GCP“) („příslušné zákony“). Zdravotnické zařízení se zdrží a zajistí, aby se hlavní zkoušející i veškerý studijní tým („personál studie“) zdržel použití hodnoceného léčiva jakýmkoliv způsobem, jenž je v rozporu s ustanoveními protokolu nebo překračuje jeho rámec, nebo je v rozporu s písemnými pokyny zadavatele. Zdravotnické zařízení a hlavní zkoušející jsou oprávněni odmítnout plnění pokynů zadavatele a nebudou vázáni povinností tyto pokyny plnit, pokud jsou tyto v rozporu s právními předpisy, Protokolem, povolením Státního ústa...
Conduct of the Study. (a) Institution and Investigator will participate in the conduct of the Study at Institution in accordance with Protocol No. XXXXX (“Protocol”), incorporated to this Agreement by reference, as it may be amended from time to time by MedImmune, subject to any approval that may be required by the Institution relevant ethics committee. Investigator will be responsible for conducting the Study. Prior to the commencement of the Study by the Institution and Investigator, Institution and Investigator will review the Protocol and notify MedImmune if it/she/he cannot comply with any of its terms. Institution and Investigator may deviate from the Protocol, except with respect to violations of the inclusion/exclusion criteria for Study subjects contained in the Protocol, only when necessary to protect the safety, rights or welfare of the Study Subjects. MedImmune/CRO shall be informed in writing of any and all deviations from the Protocol. Any such deviations and their cause shall be noted in the corresponding report as required under the Protocol for the period in which the deviation occurred and in any final report. MedImmune or its designated representatives shall be responsible for ensuring that all necessary ethics committee approvals are attained by Institution before commencement of the Study. The Study shall be performed approximately from April 2015 until the end of year 2017 and it is expected to enroll approximatelly 10 Study subjects. 1.1
