Normalized Lab Data

You can identify data as normalized lab data by defining a repeating Question Group with a single pair of questions, one to collect the lab test name and the other to collect the lab test value; see the chapter on DCMs in Oracle Clinical Creating a Study.

When you batch load lab data in a normalized format, the system automatically generates two records from each incoming normalized lab data record, for both inserts and updates. The lab test name is then stored as a Question response and you can use it in data extract and in validation Procedures to identify the test name for each test result.

For example, from records with a normalized input file format as follows:

,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,HCT,0,1,43 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,HGB,0,2,17 

where the lab test names are HCT and HGB, the respective lab test values for the patient are 43 and 17, the lab test Question name is LTEST and the lab test result name is LVALUE, the Batch Data Load process converts the preceding two input records to the following four records:

,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LTEST,0,1,HCT 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LVALUE,0,1,43 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LTEST,0,2,HGB 
,,2,,VISIT1,0,20110101,,HEMA,HEMA,HEMA,LAB,LVALUE,0,2,17