Common use of Access, Use, Monitoring and Inspection Clause in Contracts

Access, Use, Monitoring and Inspection. Site hereby agrees that in accordance with the terms set forth in this Agreement upon written notice and to the extent provided by the informed consent of Study Subject or if required by law, it shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use, unless such copies contain legally impermissible individually identifiable data of the Study Subject, provided, however, that the Site will ensure access to the records for Quintiles, Sponsor and their representatives for the purpose of conducting the study, including monitoring and auditing of the Study. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records, Study Data, other source documents and all required licenses, certificates and accreditations so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.

Access, Use, Monitoring and Inspection. Site hereby agrees that in accordance with the terms set forth in this Agreement upon written notice and to the extent provided by the informed consent of Study Subject or if required by law, it shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use, unless such copies contain legally impermissible individually identifiable data of the Study Subject, provided, however, that the Site will ensure access to the records for Quintiles, Sponsor and their representatives for the purpose of conducting the study, including monitoring and auditing of the Study. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records, Records and Study Data, other source documents and all required licenses, certificates and accreditations Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.

Access, Use, Monitoring and Inspection. Site hereby agrees that in accordance with the terms set forth in this Agreement upon written notice and to the extent provided by the informed consent of Study Subject (and set forth in the eCRFs) or if required by law, rule, regulation or guideline, it shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use, unless such copies contain legally impermissible individually identifiable data of the Study Subject, provided, however, that the Site will ensure access to the records for Quintiles, Sponsor and their representatives for the purpose of conducting the studyStudy, including monitoring and auditing of the Study. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records, Records and Study Data, other source documents and all required licenses, certificates and accreditations Data so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.

Access, Use, Monitoring and Inspection. Upon Quintiles’ or Sponsor’s request, Site hereby agrees that in accordance with the terms set forth in this Agreement upon written notice and to the extent provided by the informed consent of Study Subject or if required by law, it shall provide original or copies (as the case may be) of all Study Data to Quintiles and Sponsor for Sponsor’s use, unless such copies contain legally impermissible individually identifiable data of the Study Subject, provided, however, that the Site will ensure access ) of all Study Documentation to the records for Quintiles, Sponsor Quintiles and their representatives for the purpose of conducting the study, including monitoring and auditing of the StudySponsor. Site shall afford Sponsor and Quintiles and their representatives and designees reasonable access to Site’s facilities and to Medical Records, Records and Study Data, other source documents and all required licenses, certificates and accreditations Documentation so as to permit Sponsor and Quintiles and their representatives and designees to monitor the Study. 1.3.3.