The department will be monitored by the Coordination Centre for Clinical Trials, which will be responsible for study management, medical device safety, data management, and statistical analyses.
Medpace, Inc. (Cincinnati, Ohio), a contract research organization, performed project management, data management, clinical and safety monitoring, and statistical analyses in conjunction with Daiichi Sankyo, Inc.
The Interdisciplinary Center for Clinical Trials (IZKS) of the University of Mainz is responsible for monitoring the study and for project-, safety-, data management and biostatistics.
"The logistics side of the job, the data management and paper management," traditionally has kept safety professionals at their desks rather than talking with researchers, Watson says.
A Data Monitoring Committee (DMC), comprising two independent clinicians and one independent statistician, meets approximately every 6 months to oversee the data management and any issues relating to patient safety.
The Medical Coordinating Center (MCC) at Beth Israel Deaconess Medical Center (BIDMC) is responsible for study conduct, safety monitoring, personnel training, data management and randomisation.
Michelle Fennessy, a postdoctoral fellow in nursing at the University of California, Davis, works at the crossroads of data management, administration, and safety in hospital environments.
The organizational infrastructure includes a central data management and analysis team, a scientific advisory panel, and a data monitoring and safety board.
The organizational infrastructure of PTClinResNet includes a central data management and analysis team, a scientific advisory panel, and a data monitoring and safety board.
Details regarding data management and storage conditions within the biobank may vary according to local data safety restrictions and ethical committee voting.
