Clinical data management systems derivation

Evaluation of indicators requires the collection, storage, and analysis of data from which the indicators can be derived. A standard set of data elements must be defined. Fortunately, one only has to look at commercially available equipment management systems to determine the most common data elements used. Indeed, most of the high-end software systems have more data elements than many clinical engineering departments are willing to collect. These standard data elements must be carefully defined and understood. This is especially important if the data will later be used for comparisons with other organizations. Different departments often have different definitions for the same data element. It is crucial... 

In study-based quality management systems, such as good laboratory practice (GLP) and good clinical practice (GCP), the study number is considered as the main index variable and any other information along the meta-data model can be derived from it. With the help of the meta-data model (see Box Meta-Data Model), it can be checked easily if the information of the documented GxP-relevant process is complete. 

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