Define lab normals

Once you have added a laboratory to your site, you can define the standard values that lab applies to collected lab results. These values are also known as lab normals.

Lab normals are typically numeric values or predefined options that you need to set for lab units, low and high data ranges, normal text results, and so forth. You must define lab normals for every lab test collected for a subject. For example, if you need to collect results for a creatinine test, you must define lab normal ranges, including the lab unit, low range and high range, as well as the gender, age, and effective date for that lab test.

Lab normals are defined within the context of a laboratory. Values used for lab tests, lab units, normal text values, gender, and race are all defined by the study designer. When you define lab normals, these values appear in the drop-down for each column.

Want to see how to perform this task? Watch the video below.

Note:

Before you begin defining lab normals, consider the following notes:
  • If a lab normal is not relevant in your study, you can leave it empty. In turn, that empty lab normal row is displayed as a grayed out form table cell in the lab form.
  • If you have to specify age-dependent lab normal ranges, make sure there is no overlap between the age ranges that you enter in the Age From and Age To columns. For example, if you have to specify lab normal ranges for two different age groups (2-5 and 5-12 years), then you must specify them as follows:
    • For the first age group, enter 2 in the Age From field and 5 in the Age To field.
    • For the second age group, enter 6 in the Age From field and 12 in the Age To field.
  1. Open the study settings.
  2. On the Sites & Labs tab, select a specific mode:
    • Production Sites
    • Testing Sites
    • Training Sites
  3. Locate the site for which you are creating or managing the laboratory.
  4. On the Labs column, next to the site, click View Labs.
  5. Click the name of the laboratory for which you need to define the lab normals.
  6. On the left, in the Lab Tests column, select each test, and fill-in the following fields as needed:
    Lab Normal Description
    Lab Unit Select the unit of measure used for collecting and measuring data for the lab test. For example, select U/L or ng/mL for a creatine kinase (CK) test.
    Low Range Enter the lower limit of the reference range for the lab test. For example, 24 for a creatine kinase (CK) test.
    High Range Enter the upper limit of the reference range for the lab test. For example, 174 for a creatine kinase (CK) test.
    Normal Text Result Select the value that can be used as a reference for a lab test. For example, Negative for an HPV test.

    Note: For a lab test, you can either define values for the low range and high range or the normal test results. You cannot define both types of lab normals.
    Fasting Select the value that can be used as a reference for a subject's fasting status:
    • Yes
    • No
    • All
    By default, the All option is selected for each lab test.
    These options are defined as part of a code list (at a study level or at a global level), so the options displayed for the Fasting lab normal can be different in your study. For example, you might see Fasting and Not Fasting.

    Caution:

    Keep the Fasting and Collection Date fields visible and required. Avoid turning the toggle on for the Hidden or the turning the toggleRequiredoff from the Detail pane. This change will make the subject tag uneditable to all users and prevent lab selection and form completion.
    Gender

    Select the gender that the laboratory normals apply to for a the lab test.

    For example, for a creatine kinase (CK) test you can select Male if the values for a lab unit and low range are defined according to laboratory normals typical to men. You can select All if the lab normals apply to all genders or if your study doesn't collect data on gender.

    Note: A site user can only select one option for the Gender lab normal.
    Age From Enter a number for the minimum age included in the age range for a lab test.
    Age From Units Select the unit of measure for a subject's age.
    Age To Enter a number for the maximum age included in the age range for a lab test.
    Age to Units Select the unit of measure for a subject's age.
    Race

    Select the race that the laboratory normals apply to for the lab test. You can select All if the lab normals apply to all races or if your study doesn't collect data on race.

    Note: A site user can only select one option for the Race lab normal.
    Effective Date Enter the date from which the lab normal range became effective at the laboratory.

    If a second normal range with matching unit, age, gender, and race values is entered with a later effective date, those values are used for any visit date on or after the new effective date. The effective date is compared to the sample collection date or the visit date, if the sample collection date is not being used in a lab form.
  7. Save your changes:
    • Click Save, if you want to make any other changes to the lab normals.
    • Click Save & Close to complete this task.

Related Topics

Parent topic: Set up facilities