Conduct of the Study. 3.1 Athenex shall act as the sponsor of the Study and shall hold the IND/CTA relating to the Study; provided, however, that in no event shall Athenex file a separate IND/CTA for the Study unless required by Regulatory Authorities to do so. If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement.
3.2 Athenex shall ensure that the Study is performed in accordance with this Agreement, the Protocol and all Applicable Law, including GCP.
3.3 Athenex shall ensure that all directions from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are followed. Further, Athenex shall ensure that all Regulatory Approvals from any Regulatory Authority and/or ethics committee with jurisdiction over the Study are obtained prior to initiating performance of the Study. Athenex shall participate in and lead all discussions with any Regulatory Authority regarding the Study, provided, however, that Lilly shall have the right (but no obligation) to participate in any discussions with a Regulatory Authority, and prior review and approval of any written communications with a Regulatory Authorty, regarding matters related to the Lilly Compound.
3.4 Athenex shall maintain reports and all related documentation (paper or electronic versions as applicable) in good scientific manner and in compliance with Applicable Law. Athenex shall provide any Study information and documentation reasonably requested to enable Lilly to (i) comply with any of its legal and regulatory obligations, or any request by any Regulatory Authority, in each case, to the extent related to the Study or such the Lilly Compound, (ii) satisfy any contractual obligation to a subcontractor engaged pursuant to Section 2.4 hereof, and (iii) to determine whether the Study has been performed by Athenex in accordance with this Agreement.
3.5 Athenex shall ensure that all patient authorizations and consents, and all consents from other data subjects, for the processing, use and disclosure of their data and the Clinical Data, required under HIPAA, the EU Data Protection Directive, EU General Data Protection Regulation, and any other similar Applicable Law in connection with the Study, permit the use and sharing of the Clinical Data as set forth in this Agreement, including the sharing of Clinical Data with Lilly.
3.6 All Clinical Data, including raw data and results, generated under this Agreement, as we...
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. (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.
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.
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. (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 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. Jelikož, Zkoušející, zaměstnanec Poskytovatele,má znalosti a zkušenosti k provedení Studie a společnost Covance si přeje zadat Zdravotnickému zařízení a Zkoušejícímu provedení Studie. Jelikož, Poskytovatel a Zkoušející se chtějí podílet na provádění Studie; se proto nyní Smluvní strany dohodly takto: 1. PROVEDENÍ STUDIE (a) Poskytovatel a/nebo Zkoušející zajistí, aby všechny osoby účastnící se Studie, které jsou zaměstnanci, nezávislými dodavateli nebo zástupci Poskytovatele a/nebo Zkoušejícího, zejména pracovníci lékárny, laboratoře, radiologie, patologie či kardiologie a spolupracující osoby (xxxx xxx " Spolupracující osoby "), měly adekvátní vzdělání, znalosti a zkušenosti k provedení Studie a provedly Studii přesně, rychle a účinně a profesionálním a kompetentním způsobem v souladu s postupy pro monitorování a eskalaci. Poskytovate lzení zajistí a zaručí dodržování ustanovení a požadavků této smlouvy Spolupracujícími osobama. Pokud xx x xxxx Smlouvě uveden odkaz na závazky, z nichž Poskytovateli a/nebo Zkoušejícímu plynou povinnosti vzhledem ke službám, které může poskytovat Spolupracující osoby, takový odkaz je i odkazem na Spolupracující osoby. (b) Udělením svého souhlasu s podmínkami této Smlouvy a provedením služby pro společnost Covance Poskytova...
Conduct of the Study. 1. Provedení studie
Conduct of the Study. 1. Provedení Studie
1.1 Compliance with Laws, Regulations, and Good Clinical Practices
1.1 Soulad s Právními předpisy, nařízeními a Správnou klinickou praxí
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).
