Operational Data Systems

Clinical management technologies may be concerned with either operational or clinical data systems. Operational data refers to data that support the management and administration of a trial, including schedules, staffing, time lines, etc. Operational data are not a part of the actual submission or result set. Clinical data, on the other hand, refers to all the information that is collected for each subject enrolled in the study, including the contents of study CRFs, study group assignments, demographic information, safety and efficacy measures, etc. Typically, these are the data that will be used to answer study questions. To prepare for this Application Assignment, review the article concerned with operational data management systems and perform a Web search to identify operational systems and vendors. To complete this Application Assignment, write a 1page paper in which you identify the systems and technologies commonly used to manage operational data. Select one of the technologies and describe its relationship to data management in greater detail.

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