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).