Clinical Data Management

Clinical data management assures collection, integration and availability of data at acceptable quality and cost. It leads to the making of high-quality, reliable, and statistically sound data from clinical trials. The data management plan explains the activities to be conducted in the processing data and used for description of data sources, data handling process and data control procedures. Clinical trials using an electronic CRF database design and also using paper CRF. Validation rules are electronic analysis explains in advance which make sure the integrity and uniformity of the clinical trial data. An electronic CRF is used data entry is drifting out towards the inspector site where the clinical trials are conducted. Samples which are collected during clinical trial they are sent to be a single central laboratory analysis. The CRF collects adverse events disclosed during the conduct of the clinical trial, there is a separate process which make sure that serious adverse events are disclosed quickly. The clinical data manager must make sure that data is reconciled between these processes.

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