Data entered on a lab form is compared against the lab ranges which are based on the range type variables (age, sex, etc.). Based on the Location Method that is selected on the CRF draft, the system locates the range type variable value and selects the appropriate range based on that.
For example, if AGE is defined as a Range Type variable, and in the current CRF Draft, the AGE variables appear on three forms: DEMOG, VISIT, and LAB. Subject Data is entered as follows:
Form |
Record Date |
Age (BIRTHDT= 20-NOV-1983) |
DEMOG |
1-JAN-2004 |
20 |
VISIT |
1-NOV-2005 |
21 |
Lab Form |
1-DEC-2005 |
22 |
In the above example, based on the Location Method selected, the system will use the following AGE value to determine the appropriate lab range:
Note: The system uses the Record Date to process the information. If a Record Date is not set, it uses the Data Page date. If Data Page date is not set, it uses the Instance Date, and if the Instance Date is not set, the system uses the Subject Date.
Location Method |
Field Location |
Age Selected |
Description |
Earliest Date |
First form (by date) for the subject that contains the variable |
20 |
System uses the age entered on the DEMOG form. It is the form with the earliest Record Date that contains the variable AGE. |
Latest Date |
Last form (by date) for the subject that contains the variable |
22 |
System uses the age entered on the Lab form. It is the form with the latest Record Date that contains the variable AGE. |
Closest in time to lab date |
Form with the closest date to the date of the lab form that contains the variable |
21 |
System uses the Age entered on the VISIT form. It is the form with the Record Date that is closest to the Record Date of the LAB form. |
Closest in time prior to lab date |
Form with the closest date prior to the date of the lab form that contains the variable |
21 |
System uses the Age entered on the VISIT form. It is the form with the Record Date that is closest to and is before the Record Date of the LAB form. |
On lab page |
Range variable is on the lab form itself |
22 |
System uses the Age entered on the LAB form. |
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