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At the maintenance phase, monitoring will be done to ensure that the ON is still valid and efficient for what it was created for.
The medical monitoring will be done by two independent oncologists not involved in conducting this trial.
Monitoring will be done at the Clinical Centre, or by the GP.
Monitoring will be done at intervals recommended by the Centre Clinical Lead.
Monitoring will be done by personal visits from clinical monitors according to the SOPs of the independent, external CRO.
From 2 to 3 years, monitoring will be done every 4 months, and after 3 years, every 6 months.
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Although donors have a say when deciding on programs, government KIs said that the GoN makes final decisions independently and also decides on the spending, procurement and how monitoring and evaluation will be done.
Data management, query management and monitoring of the study will be done by the Coordination Center for Clinical Trials at the Martin Luther University of Halle-Wittenberg (KKSH).
External monitoring of entries in the electronic CRF will be done by independent monitors from KKS Heidelberg.
"So in order for people to be sure when they fit certain measures that they will pay for themselves, we need robust testing and monitoring - the sort of thing that will be done at the University of Salford".
Capacity building on monitoring and evaluation tools, processes and procedures will be done at the initial stage of the project.
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