Lab management
In a clinical trial, subjects undergo various examinations and laboratory tests to assess their health condition and response to the studied item. In the EDC application, when subject lab results are entered in respective forms of the DATA ENTRY tab, the system automatically compares the data against the normal ranges preset for those exact lab tests.
To enable the EDC system to manage and validate the CRFs related to specific lab results, you need to create and define lab data and set up normal ranges—all of which can be performed under the subtabs of the Lab functionality, namely:
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Lab defining: add and define new labs, and manage the existing ones.
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Normal range management: configure and maintain normal ranges for the sites participating in the study.
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Summary of labs: view the summary of the lab data entered for your study.