Common use of Responsibilities of the CRO Clause in Contracts

Responsibilities of the CRO. The CRO undertakes to: provide the Institution, the Site, and the Principal Investigator with the complete Protocol. If the Protocol is provided in English, the CRO shall have the Protocol Synopsis translated into Polish; provide the Institution, the Site, and the Principal Investigator, no later than 14 days before the planned date of first patient recruitment, with official approval for the conduct of the Clinical Trial; notify the Site and Principal Investigator of the name and contact details of the Trial monitor at the beginning of the Clinical Trial and each time the monitor is replaced; provide the Principal Investigator with complete documentation necessary to conduct the Clinical Trial, including the Protocol and the Investigator’s Brochure, within a time that makes it possible for them to get acquainted with the way the Clinical Trial is to be conducted; organise an initiating visit and train the Principal Investigator and members of the Trial Team to ensure proper performance of the Clinical Trial at the Site; collect any unused or expired Investigational Medicinal Product supplied for the purposes of the Clinical Trial or cover the costs of its return or disposal; notify the Institution and the Site, within the agreed reporting periods, of the number of Participants and their completed visits, as well as of the optional procedures performed, as referred to in Appendix No. 1 hereto, along with the dates of such visits and optional procedures, and of the Clinical Trial completion date (end of the active phase and closing the Clinical Trial at the Site); if Trial data are to be processed using methods based on IT systems, the CRO shall provide the members of the Trial Team with free access to these systems along with written instructions for their use.

Responsibilities of the CRO. The CRO undertakes to: provide the Institution, the Site, Institution and the Principal Investigator with the complete Protocol. If the Protocol is provided in English, the CRO shall have the Protocol Synopsis translated into Polish; provide the Institution, the Site, Institution and the Principal Investigator, no later than 14 days before the planned date of first patient recruitment, with official approval for the conduct of the Clinical Trial; notify the Site Institution and Principal Investigator of the name and contact details of the Trial monitor at the beginning of the Clinical Trial and each time the monitor is replaced; provide the Principal Investigator with complete documentation necessary to conduct the Clinical Trial, including the Protocol and the Investigator’s Brochure, within a time that makes it possible for them to get acquainted with the way the Clinical Trial is to be conducted; organise an initiating visit and train the Principal Investigator and members of the Trial Team to ensure proper performance of the Clinical Trial at the Site; collect any unused or expired Investigational Medicinal Product supplied for the purposes of the Clinical Trial or cover the costs of its return or disposal; notify the Institution and the SiteInstitution, within the agreed reporting periods, of the number of Participants and their completed visits, as well as of the optional procedures performed, as referred to in Appendix No. 1 hereto, along with the dates of such visits and optional procedures, and of the Clinical Trial completion date (end of the active phase and closing the Clinical Trial at the Site); if Trial data are to be processed using methods based on IT systems, the CRO shall provide the members of the Trial Team with free access to these systems along with written instructions for their use.