Guidelines for subject tags and code lists in lab forms

If you ever find yourself stuck with defining subject tags or code lists for your lab forms, these additional guidelines might help you troubleshoot or work around some of the issues you may encounter.

All of the required questions in a lab form are already predefined in the system, therefore all you have to do is either add items or questions that you think are required in a lab form and edit lab tests, so site users can know which lab tests they're collecting data for. Moreover, lab tests and lab results are already tagged with the appropriate lab normals tag, so you don't have to do that. If you need to create multiple lab forms, we recommend you create new code lists for the items requiring code lists, and tag those code lists appropriately.

The guidelines listed below are organized by type of element, including subject tags and predefined code lists for forms.

How dates work when it comes to lab normal values

In the absence of a sample collection date, the visit date is also used to trigger the effective date of a lab normal value or range, as well as calculate the age of a subject against the date of birth.

Code lists

When it comes to code lists, you can create multiple code lists with the same tag, whether it's Gender, Race, Lab Tests, or Lab Units, as long as those code lists don't contain duplicate values or codes. You can also modify the pre-existing code lists as you see fit for your lab form and lab normal values.

Additionally, you must know that, for the Fasting question, if there is only one code list defined for Fasting and tagged as such, the system automatically uses the values in those code list to integrate the appropriate lab normal values. If there are multiple code lists created and tagged for Fasting, the system does not select one code list by default and a study designer must select the appropriate code list for the Fasting question in the respective lab form.

Subject tags

When it comes to subject tags, you must know that in order to effectively collect lab data using a lab form, you must have three types of questions defined and tagged in your study: a question on a subject's date of birth, a question on gender, and a question on race.

Note:

You should define questions on race and gender as questions with radio buttons. We typically recommend you include these questions on a Screening form, but it's ultimately up to you where you choose to include these questions.

Subject tag	Description
Race subject tag	The predefined Race code list is already tagged appropriately with the Race tag. You can always modify the code list values. For more details, see Tag questions on date of birth, gender, and race. As for lab normal ranges, a site user or data manager can only select a single option when defining the lab normal values and ranges for lab tests.
The Gender subject tag	The predefined Gender code list is already tagged appropriately with the Gender tag. You can always modify the code list values or create a new one as long as you tag it appropriately. For more details, see Tag questions on date of birth, gender, and race. As for lab normal ranges, a site user or data manager should select a single option when defining the lab normal values and ranges for lab tests.
The Date of Birth subject tag	First off, you must have a date/time question appropriately tagged with the Date of Birth subject tag in order for the system to calculate a subject's age. The date/time question may also allow partial dates to collect a subject's age. If your study uses partial dates to collect a subject's date of birth, a subject's age is then calculated by comparing the collected date of birth against the Visit Date or the Sample Collection Date.
Sample Collection Date	The question can be defined to include a time element, as well as partial dates with a minimum accepted date format. This question allows a site user to enter the collection date of a lab test and the system to properly calculate a subject's current age, as well as choose the normal range with the correct effective date.
Fasting	This question uses the Fasting code list, tagged appropriately. You can edit that code list as you see fit for your study design. This question allows a site user to collect data on a subject's fasting status and must have a single answer.