Clinical data management

Clinical data management ensures that data is collected, integrated, and available at an appropriate quality and cost. It leads to the generation of high-quality, dependable, and statistically sound clinical trial data. The data management plan describes the tasks to be performed in the data processing process and is used to describe data sources, data handling processes, and data control procedures. Clinical trials employing both an electronic CRF database design and a paper CRF. Validation rules are computerised analytic procedures that ensure the integrity and consistency of clinical trial data. Data entry is moving out towards the inspection site where the clinical trials are done using an electronic CRF. Samples obtained during clinical trials are sent to a single central laboratory for analysis. The CRF gathers adverse events reported during the course of the clinical trial; there is a distinct protocol in place to ensure that major adverse events are reported as soon as possible. The clinical data manager has responsibility for ensuring that data is reconciled between different processes.

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