Common use of Conduct of the Study Clause in Contracts

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. 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 '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 (“IECslECs”) 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. 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”), applicable federal, state, and local laws, regulations and guidelinesguidelines 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 investigatorPrincipal Investigator’s brochure or device labeling instructions, 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 .. 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 Quintiles PRA and the sponsor of the Study (the “Sponsor”) 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 Quintiles PRA and Sponsor who visit the SiteInstitution, and the Site Institution agrees to ensure that the employees, agents and representatives of the Site 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 drugProtocol and the applicable informed consent form and shall not collect or reserve additional 1) Realizace Studie. Smluvní strany zde připojené smlouvy („Smlouva“) souhlasí s tím, device, product or compound being tested že tam popsané klinické hodnocení (the „Studie“Investigational Product”) bude realizováno v přísném souladu s příslušným protokolem a jeho případnými aktualizacemi („Protokol“), and any comparator products provided in connection with the Studyplatnými zákonnými a podzákonnými předpisy České republiky, solely for the purpose of properly completing the Study and shall maintain all Investigational Product and any comparator products in směrnicemi a lockedsprávnou klinickou praxí („GCP“), secured area at all timeszejména v souladu s platnými směrnicemi Mezinárodní konference o harmonizaci technických požadavků pro registraci léčivých přípravků pro humánní použití, a zejména v souladu se zákonem č. Upon completion or termination of the Study378/2007 Sb., the Site shall return all unused Investigational Producto léčivech a o změnách některých souvisejících zákonů („zákon o léčivech“) a v souladu s vyhláškou č. 226/2008 Sb., comparator productso správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků, equipmentve znění pozdějších předpisů, and materials and all Confidential Information (as defined below)a v souladu se zákonem č.