ABSTRACT
Whatever the source, managing laboratory data frequently represents a goodsized portion of the data management effort for a study. Some of this is due to the sheer volume of the result data and the rest is due to the numerous tasks that are associated with managing this data. Many data management groups designate one or more staff members as lab data administrators or coordinators. When viewing all of the tasks that need to be managed with lab data, it is easy to see why someone may take this on as a full-time assignment. Lab data administrators do the following:
• Provide input into CRF and eCRF design • Answer study setup questions about analytes • Coordinate with central laboratories • Specify or even write loading programs (for electronic —les) • Check —le formats and track data deliveries (for electronic —les) • Oversee entry questions (for CRF data) • Resolve questions of units • Maintain conversion formulas to standard units • Run and/or review cleaning checks • Identify and help resolve discrepancies • Keep normal range data current
In this chapter, we will look at how lab data and the associated units are stored and how that data is checked and cleaned. Central lab data provided in the form of electronic —les is introduced here, but the management of data from external sources is discussed in the next chapter, Chapter 10, “Non-CRF Data.”
