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. (a) 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 and/or Investigator, 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 accurately, efficiently and expeditiously perform the Study in a professional and competent manner. 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. Study shall be performed at the site of Nemocnice Benešov, Rudolfa a Xxxxxxxx Benešov, a.s., nemocnice Xxxxxxxxxxxxx xxxxx, Xxxxxxx 000, 000 00 Xxxxxxx, Xxxxx Xxxxxxxx. SMK shall perform administrative tasks with full responsibility of the Investigator. (b) By agreeing to the terms and conditions of this Agreement and performing the services for Xxxxxxxx, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity. (c) To the extent terms and conditions in this Agreement and the Protocol conflict, the terms and conditions of the Protocol shall control with respect to scientific, medical, patient consent, and any other issues directly relating to the conduct of the Study and keeping of records (x.x.xxxx report forms) associated therewith, and the provisions of the main body of this Agreement shall control with respect to all other issues. (d) Institution agrees to perform formal patient screening and randomisation for the Study only after Xxxxxxxx has confirmed in writing (which could be via email) to Institution that all essential documents, as defined by ICH/GCP or equivalent standard, are in place and proper or appropriate Ethics Committee, Regulatory Authority and/or 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, SMK a Zkoušející se chtějí podílet na provádění Studie; Vzhledem k výše uvedenému se Smluvní strany dohodly takto: 1. PROVEDENÍ STUDIE (a) Zdravotnické zařízení a/nebo Zkoušející zajistí, aby všechny osoby účastnící se St...
Conduct of the Study. (a) 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 and/or Investigator, including but not limited to pharmacy, laboratory. Radiology, pathology, cardiology and other nursing staff (hereinafter „Research Staff”) have the knowledge and experience to undertake the Study and shall accurately, efficiently and expeditiously perform the Study in a professional and competent manner. Investigator shall ensure and warrant compliance with the provisions and requirements of this Agreement by Research Staff. 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) By agreeing to the terms and conditions of this Agreement and performing the services for Covance, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity. (c) To the extent terms and conditions in this Agreement and the Protocol conflict, the terms and conditions of the Protocol shall control with respect to scientific, medical, Study subject consent, and any other issues directly relating to the Jelikož, Zkoušející, zaměstnanec Zdravotnického zařízení, má znalosti a zkušenosti k provedení Studie a společnost Covance si přeje zadat Zdravotnickému zařízení a Zkoušejícímu provedení Studie. Jelikož, Zdravotnické zařízení a Zkoušející se chtějí podílet na provádění Studie; Jelikož Strany uzavřou Dohodu o ochraně údajů (dále jen "DPA") týkající se nařízení 2016/679 o obecné ochraně údajů v souvislosti s klinickými hodnoceními; se proto nyní Smluvní strany dohodly takto: 1. PROVEDENÍ STUDIE (a) Zdravotnické zařízení a/nebo Zkoušející zajistí, aby všechny osoby účastnící se Studie, které jsou zaměstnanci, nezávislými dodavateli nebo zástupci Zdravotnického zařízení a/nebo Zkoušejícího, zejména pracovníci lékárny, laboratoře, radiologie, patologie či kardiologie a další zdravotnický personál (dále jen "Výzkumný personál") mají znalosti a zkušenosti k provedení Studie a provedou Studii přesně, rychle a účinně a profesionálním a kompetentním způsobem. Zkoušející zajistí a zaručí dodržování ustanovení a požadavků této Smlouvy Výzkumným personálem. Pokud je v této Smlouvě uveden odkaz na...
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. 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”) 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”), applicable federal, state, and local laws, regulations and guidelines, and good clinical practices (“GCPs”). The Principal Investigator (the “Investigator”) shall review all case report forms (“CRFs”) to ensure their accuracy and completeness, shall review and understand the information in the investigator’s brochure or device labeling instructions, as applicable, shall ensure that all informed consent requirements are met, and shall ensure that all required reviews and approvals (or favorable opinions) by applicable regulatory authorities and Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) are obtained. The Investigator and the institution(s) (the “Institution”), if any, conducting the trial (jointly, the “Site”) agree 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 Quintiles and the sponsor of the Study (the “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 agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Site, and the Site agrees to ensure that the employees, agents and representatives of the Site do not harass, or otherwise create a hostile working environment for, such representatives. The Site shall use the drug, device, product or compound being tested (the “Investigational Product”), and any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and shall maintain all Investigational Product and any comparator products in a locked, secured area at all times. Upon completion or termination of the Study, the Site shall return all unused Investigational Product, comparator products, equipment, and materials and all Confidential Information (as defined below).
Conduct of the Study. (a) Institution agrees that its employee, agent or contractor of Xx. Xxxxxx Xxxxxx, Cardiologist, Interni oddeleni (hereinafter referred to as “Investigator”) will conduct the Clinical Trial at the Institution under terms and conditions separately agreed between Covance and Investigator. Wherever, in this Agreement, reference is made to obligations which are incumbent on the Investigator, such reference is intended for the purpose of informing the parties to this Agreement accordingly. (b) Institution shall ensure that all persons who have involvement in the Study and who are employees, independent contractors or agents of Institution and/or Investigator, 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 accurately, efficiently and expeditiously perform the Study in a professional and competent manner. Institution shall ensure and warrant compliance with the provisions and requirements of this Agreement by Research Staff. 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. (c) By agreeing to the terms and conditions of this Agreement and performing the services for Covance, Institution represents and warrants that it and the Investigator are not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity. (d) To the extent terms and conditions in this Agreement and the Protocol conflict, the terms and conditions of the Protocol shall control with respect to scientific, medical, patient consent, and any other issues directly relating to the conduct of the Study and keeping of records (e.g. case report forms) associated therewith, and the provisions of the main body of this Agreement shall control with respect to all other issues. (e) Institution agrees to perform formal patient screening and randomisation for the Study only after Covance has confirmed in writing (which could be via email) to Institution that all essential documents, as defined by ICH/GCP or equivalent standard, are in place and proper or appropriate Ethics Committee, Regulatory Authority and/or other competent authority approval has been received. (f) Any subcontracting of any of Institution´s obligations und...
Conduct of the Study. (a) 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 and/or Investigator, including but not limited to pharmacy, laboratory. radiology, pathology, cardiology and nursing staff (hereinafter „Research Staff”) are adequately trained, have the knowledge and experience to undertake the Study and shall accurately, efficiently and expeditiously perform the Study in a professional and competent manner in compliance with monitoring and escalation process. Institution shall ensure and warrant compliance with the provisions and requirements of this Agreement by Research Staff. 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) By agreeing to the terms and conditions of this Agreement and performing the services for Labcorp, Institution and Investigator each represent and warrant that it/he/she is not in violation of any terms and conditions of any agreement for services or employment with any other individual or entity. (c) To the extent terms and conditions in this Agreement and the Protocol conflict, the terms and conditions of the Protocol shall control with respect to scientific, medical, patient consent, and any other issues directly relating to the conduct of the Study and keeping of records (e.g. case report forms) associated therewith, and the provisions of the main body of this Agreement shall control with respect to all other issues. (d) Institution agrees to perform formal patient screening and randomisation for the Study only after Labcorp has confirmed in writing (which could be via email) to Institution that all essential documents, as defined by ICH-GCP or equivalent standard, are in place and proper or appropriate Ethics Committee (“EC”), Institutional Review Board (“IRB”), Regulatory Authority (as defined in ICH-GCP) and/or other competent authority approval has been received. 1. PROVEDENÍ STUDIE (a) Zdravotnické zařízení a/nebo Zkoušející zajistí, aby všechny osoby účastnící se Studie, které jsou zaměstnanci, nezávislými dodavateli nebo zástupci Zdravotnického zařízení a/nebo Zkoušejícího, zejména pracovníci lékárny, laboratoře, radiologie, patologie či kardiologie a zdravotnický personál (dále jen "Výzkumný personál") byly odpovídajícím způsobem vyškol...
Conduct of the Study. The Institution shall (and shall cause the Principal Investigator to) 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 United States Food and Drug Administration (“FDA”) and the International Conference on Harmonization Good Clinical Practice (“ICH GCP”) guidelines, (“Applicable Law”). The Institution shall refrain from, and shall cause the Principal Investigator and any other employee, contractor, or agent performing or assisting with the Study on behalf of the Institution (“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. 1.2 Provádění studie. Zdravotnické zařízení bude (a zajistí, že hlavní zkoušející bude) studii provádět v souladu s touto smlouvou, protokolem, všemi odpovídajícími písemnými pokyny zadavatele a všemi příslušnými zákony a předpisy, zejména veškerými příslušnými požadavky Úřadu pro kontrolu potravin a léčiv USA (United States Food and Drug Administration, „FDA“) a směrnicemi Mezinárodní konference pro harmonizaci upravujících správnou klinickou praxi (International Conference on Harmonization Good Clinical Practice, „ICH GCP“) („příslušné zákony“). Zdravotnické zařízení se zdrží a zajistí, aby se hlavní zkoušející a každý jiný zaměstnanec, smluvní dodavatel nebo zástupce provádějící studii nebo se na ní podílející jménem zdravotnického zařízení („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.
