15 Lab Ranges
Lab ranges allow you to check the validity of lab data in a validation procedure. You can set standard ("textbook") ranges of acceptable values for lab test Questions according to company standards. If a particular study needs to use a different range of values for a particular Question, you can define an overriding lab range for that Question. In either case, you also enter information into the system about the labs that are processing the tests, and associate the appropriate lab ranges with the labs.
If a lab test result is out of range and a validation procedure is defined to detect it, Oracle Clinical creates a discrepancy in the Discrepancy Database that must be examined by clinical personnel.
You also enter information about each acceptable measuring unit for each Question, which unit is preferred, and how to convert to that unit so that all the data for the Question can be easily compared.
Before you begin working with the functionality available in the Lab Ranges subsystem, you must have all the required lab test Questions defined in the Global Library (see Questions and Question Groups).
You can batch load lab-related definitions, which is described in the final section of this chapter.
For replication across a distributed study, some lab information (Lab Units and panels) must be defined at the Global Library location, while other lab information (labs, lab ranges, and lab assignment criteria (LACs)) must be defined at the study-owning location.
For more information, see: