Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor who visit the Institution for the purposes of monitoring and audit, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit IQVIA and Sponsor to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections.
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Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. In addition, and without limitation on the foregoing, Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to InstitutionInstitution ’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to InstitutionInstitution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data, as required by GCP and applicable laws and regulations. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor who visit the Institution for the purposes of monitoring and auditInstitution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, impede or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify IQVIA in writting of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit IQVIA and Sponsor to attend any such inspectionsinspections to the extent permitted by applicable laws and regulations. The Institution will make reasonable efforts to separate, and not disclose, all any Confidential Information that is not required to be disclosed during such inspections.
Appears in 1 contract
Samples: Clinical Trial Agreement
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor GSK for SponsorGSK’s use. Institution shall afford Sponsor GSK and IQVIA and their representatives and designees reasonable access to InstitutionInstitution ’s facilities and to Medical Records and Study Data so as to permit Sponsor GSK and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to InstitutionInstitution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor GSK who visit the Institution for the purposes of monitoring and auditInstitution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and and, unless legally prohibited, the Institution shall permit IQVIA and Sponsor GSK to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections. informacím (ve smyslu níže uvedeném) a k jakýmkoli jiným Studijním datům a údajům.
Appears in 1 contract
Samples: Clinical Trial Agreement
Access, Use, Monitoring and Inspection. Institution shall Institutionshall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to Institution’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor who visit the Institution for the purposes of monitoring and auditInstitution, and the Institution agrees Institutionagrees to ensure that the employees, agents and representatives of the Institution do Institutiondo not harass, or otherwise create a hostile working environment for such representatives. The Institution shall Institutionshall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall Institutionshall permit IQVIA and Sponsor to attend any such inspections. The Institution will Institutionwill make reasonable efforts to separate, and not disclose, all Confidential Information that is thatis not required to be disclosed during such inspections.
Appears in 1 contract
Samples: Clinical Trial Agreement
Access, Use, Monitoring and Inspection. Institution shall provide original or copies (as the case may be) of all Study Data to IQVIA and Sponsor for Sponsor’s use. Institution shall afford Sponsor and IQVIA and their representatives and designees reasonable access to Institution’s facilities and to Medical Records and Study Data so as to permit Sponsor and IQVIA and their representatives and designees to monitor the Study. Institution shall afford regulatory authorities reasonable access to InstitutionInstitution ’s facilities and to Medical Records and Study Data, and the right to copy Medical Records and Study Data. The Institution agrees to cooperate with the representatives of IQVIA and Sponsor Xxxxxxx who visit the Institution for the purposes of monitoring and auditInstitution, and the Institution agrees to ensure that the employees, agents and representatives of the Institution do not harass, or otherwise create a hostile working environment for such representatives. The Institution shall immediately notify IQVIA of, and provide IQVIA copies of, any inquiries, correspondence or communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Institution’s facilities, and the Institution shall permit IQVIA and Sponsor to attend any such inspections. The Institution will make reasonable efforts to separate, and not disclose, all Confidential Information that is not required to be disclosed during such inspections.
Appears in 1 contract
Samples: Clinical Trial Agreement