Adding Reference Ranges for Labs
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You can enter Reference Ranges for a lab on the Lab Maintenance page if you have the Lab Maintenance role action permission.

You can maintain valid lab ranges for a lab in the Lab Analyte Ranges page.  The Lab Analyte Ranges page displays information on Analyte name and units, including dynamic fields that are determined from the range type for the lab.  

Note: You cannot edit lab ranges, create new versions of lab ranges, or add new ranges for central labs in EDC.  Any Central lab range is view-only.   

1. Navigate to a Study > Site > Subject > A lab form.

2. Select a lab from the dropdown list of labs.

3. Click edit .

The <Lab Name> - Analyte Ranges page displays a list of all active ranges that have been defined, if any.

4. Click Add New Range .

5. Complete the required fields.

6. Click Update .

The system validates the data for the following criteria:

1. • From Date must be less than To Date

   • For variables with a low and a high value, the standard value for Low must be less than or equal to the standard value for High

   • A variable value can be left blank if it is a character data type.  For example, "Sex" may be blank to indicate both sexes.  "From Age" cannot be blank.

   • Low value and High value are required, unless a data dictionary is specified.  

   • The range must not overlap with any other range.  For example, a range for a sex of "Male" cannot overlap a range for a sex of "Female".

7. To edit the information for a lab range, click edit .

8. To create a different version of an existing range, click New Version . The new version of the range contains all data except the From and To dates. The date defaults to the current subject's visit date if you are maintaining the range in EDC. You may edit the value for From Date.

Note: If a lab range changes or a new range is added, the system resets the Approved Flag for a lab to Unapproved.

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