Clinical data management systems study conduct

Systems audits in this late phase in clinical trials aim at assessing related procedures to ensure that capable procedures exist for managing and cleaning clinical trial data, for conducting statistical analyses and for preparing the final study report which represents properly the data collected and reported in the clinical trial. Such systems audits are performed across functional boundaries. Such systems audit can be combined with a database audit and/or an audit of the final study report. 

Clinical studies may be supported by computer systems in a number of ways from data capture, data processing, production control, and document management. Some systems may be complex, others simple. Some systems may be custom-made, others based on COTS products. Whatever the character of a clinical computer system, the same basic GCP/GLP principles apply. All computer systems that play a part in the conduct or support of clinical studies intended for regulatory... 

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