Monitoring and Audit. 1.8.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study. 1.8.2 Institution/Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
Appears in 11 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Monitoring and Audit. 1.8.1 2.8.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 2.8.2 Institution/Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor or its representatives (including the CRO) to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor or its representative of source documents shall be performed with due regard for Study subject confidentiality.
Appears in 4 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Monitoring and Audit. 1.8.1 1.7.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 Institution/Principal Investigator 1.7.2 National Coordinator shall during the Studyinform Institutions, that Institutions shall - on reasonable prior written notice and at an agreed upon time, during the Study - permit authorized personnel of Sponsor to access the site sites during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
Appears in 2 contracts
Monitoring and Audit. 1.8.1 1.7.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 1.7.2 Institution/Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
1.7.3 Institution/Investigator is obliged throughout the trial to keep local printed documents in the Site Master File up to date using the trial websites log for such updates.
Appears in 2 contracts
Monitoring and Audit. 1.8.1 Sponsor shall must provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 Institution/Principal Site Investigator shall must, during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
Appears in 1 contract
Samples: Clinical Trial Agreement
Monitoring and Audit. 1.8.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 Institution/Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject confidentiality.
1.8.3 Institution/Investigator is obliged throughout the trial to keep local printed documents in the Site Master File up to date using the trial websites log for such updates.
Appears in 1 contract
Samples: Clinical Trial Agreement
Monitoring and Audit. 1.8.1 Sponsor shall provide reasonable supervision, training and monitoring during the conduct of the Study.
1.8.2 Institution/Principal Investigator shall during the Study, on reasonable prior written notice and at an agreed upon time, permit authorized personnel of Sponsor to access the site during normal business hours in order to conduct monitoring and audits. Any review by Sponsor of source documents shall be performed with due regard for Study subject subject’s confidentiality.
Appears in 1 contract
Samples: Clinical Trial Agreement