Common use of ASSURANCE AND MONITORING Clause in Contracts

ASSURANCE AND MONITORING. All initiation visits, onsite monitoring visits, close-out visits and in-house monitoring will be conducted by monitors of Hannover Clinical Trial Center (HCTC). HCTC SOPs will be utilized. Prior to the start of the study, pre-study visits by the primary investigators will be conducted to be able to instruct the local investigators in how to follow the study protocol and documentation of data. Initiation visits will be done in each study center prior to patient recruitment to ensure adherence with all study procedures by the monitor of HCTC and the study coordinators. To assure high data quality and patients safety, regular on-site monitoring visits will be performed by HCTC monitors. Checking of signed informed consents and source data verification will be carried out according to a risk adapted approach. At the end of the study, close out visits will be performed at all study sites. Project managers, monitors, study coordinators and PIs will be in close and regular contact throughout the study and with all study sites. Monitoring details will be summarized in a monitoring plan which will be prepared by the project manager (HCTC). The monitoring plan will be reconciled with the coordinating investigator and members of the clinical project management. It will serve as guiding document for all monitors and will contain details on monitoring activities, responsibilities and interfaces between study team, data management, source data and adverse events. In- house monitoring will assure high data quality. Data capture will be achieved by electronic data capture (electronic CRF). On-site source data verification will be done according to a risk adapted monitoring afterwards. In total, 3 monitoring visits are planned per study site.

ASSURANCE AND MONITORING. All initiation visits, onsite monitoring visits, close-out visits and in-house monitoring will be conducted by monitors of Hannover Clinical Trial Center (HCTC). HCTC SOPs will be utilized. Prior to the start Before beginning of the study, study pre-study visits by the primary investigators will be conducted to be able to instruct the local investigators in how to follow the study protocol and documentation of data. Initiation visits will be done in each study center centre prior to patient recruitment to ensure adherence with all study procedures by the monitor of HCTC and the study coordinatorsHCTC. To assure high data quality and patients safety, safety regular on-site monitoring visits will be performed by HCTC monitors. Checking of signed informed consents and source data verification will be carried out according to a risk adapted approach. At the end of the study, study close out visits will be performed at all study sites. Project managers, monitors, study coordinators monitors and PIs will be in close and regular contact throughout the study and with all study sites. Monitoring details will be summarized in a monitoring plan which will be prepared by the project manager (HCTC). The monitoring plan will be reconciled with the coordinating investigator and members of the clinical project management. It will serve as guiding document for all monitors and will contain details on monitoring activities, responsibilities and interfaces between study team, data management, source data and adverse events. In- house monitoring will assure high data quality. Data capture will be achieved by electronic data capture (electronic CRF). On-site source data verification will be done according to a risk adapted monitoring afterwards. In total, 3 monitoring visits are planned per study site.

ASSURANCE AND MONITORING. All initiation visits, onsite monitoring visits, close-out visits and in-house monitoring will be conducted by monitors of Hannover Clinical Trial Center (HCTC-KKS). HCTC HCTC-KKS SOPs will be utilized. Prior to the start of the study, pre-study visits by the primary investigators will be conducted to be able to instruct the local investigators in how to follow the study protocol and documentation of data. Initiation visits will be done in each study center prior to patient recruitment to ensure adherence with all study procedures by the monitor of HCTC HCTC-KKS and the study coordinators. To assure high data quality and patients safety, regular on-site monitoring visits will be performed by HCTC HCTC-KKS monitors. Checking of signed informed consents and source data verification will be carried out according to a risk adapted approach. At the end of the study, close out visits will be performed at all study sites. Project managers, monitors, study coordinators and PIs will be in close and regular contact throughout the study and with all study sites. Monitoring details will be summarized in a monitoring plan which will be prepared by the project manager (HCTC-KKS). The monitoring plan will be reconciled with the coordinating investigator and members of the clinical project management. It will serve as guiding document for all monitors and will contain details on monitoring activities, responsibilities and interfaces between study team, data management, source data and adverse events. In- In-house monitoring will assure high data quality. Data capture will be achieved by electronic data capture (electronic CRF). On-site source data verification will be done according to a risk adapted monitoring afterwards. In total, 3 monitoring visits are planned per study site.

ASSURANCE AND MONITORING. ‌ All initiation visits, onsite monitoring visits, close-out visits and in-house monitoring will be conducted by monitors of Hannover Clinical Trial Center (HCTC). HCTC SOPs will be utilized. Prior to the start Before beginning of the study, study pre-study visits by the primary investigators will be conducted to be able to instruct the local investigators in how to follow the study protocol and documentation of data. Initiation visits will be done in each study center centre prior to patient recruitment to ensure adherence with all study procedures by the monitor of HCTC and the study coordinatorsHCTC. To assure high data quality and patients safety, safety regular on-site monitoring visits will be performed by HCTC monitors. Checking of signed informed consents and source data verification will be carried out according to a risk adapted approach. At the end of the study, study close out visits will be performed at all study sites. Project managers, monitors, study coordinators monitors and PIs will be in close and regular contact throughout the study and with all study sites. Monitoring details will be summarized in a monitoring plan which will be prepared by the project manager (HCTC). The monitoring plan will be reconciled with the coordinating investigator and members of the clinical project management. It will serve as guiding document for all monitors and will contain details on monitoring activities, responsibilities and interfaces between study team, data management, source data and adverse events. In- house monitoring will assure high data quality. Data capture will be achieved by electronic data capture (electronic CRF). On-site source data verification will be done according to a risk adapted monitoring afterwards. In total, 3 monitoring visits are planned per study site.