Integrate more relevant data in lab forms

Study designers can now define a sample collection date field in lab forms, as well as create a question on a subject's fasting status. Site users must answer these questions before collecting data in a lab form.

What are the benefits?

With these new questions, study designers can create more robust lab forms that allow site users to collect better, more detailed lab data. The sample collection date allows the system to accurately calculate the subject's age at the time of collection and allows for proper integration of normal ranges based on a subject's age and the effective date of the lab normal range. Including a question on a subject's fasting status further improves the collection of specific lab normal ranges.

Details for study designers

On the Forms tab, when creating a lab form, you will notice the form contains two new predefined questions placed first, before the Label item defined in the lab form. These questions are:

• Sample Collection Date: A Date/Time required question that is tagged with a new Sample Collection Date lab normals tag.
• Fasting: A required drop-down type of question that is tagged with a new Fasting lab normals tag. The question also has an Exactly 1 validation rule applied to it. Additionally, this question also includes a new code list that is already tagged with the Fasting code list tag. Values in the code list are predefined as Yes and No. This question can also be changed to a question with radio buttons with no validation rules.

If needed, these two questions can be hidden from the lab form. If you choose to hide any of the two new questions, you can also classify them for other users to view or edit, if they have the appropriate permissions.

Figure 16-4 How a study designer sees the two new introductory questions

Details for data managers and site users

Whether you're a data manager or a site user who needs to define lab normal values and ranges for a local lab, you should know that, on the Sites & Labs tab, there's a new Fasting column that uses the All option, by default. For each lab test, you can change that value to indicate whether the range applies to a fasting or non-fasting subject.

Additionally, there are more updates for a site user's workflow. When starting a visit that contains a lab form with the two new introductory questions, you must first answer the Sample Collection Date and Fasting questions. Afterwards, you must select a lab for which the lab data will be collected. Only after you perform these three tasks you will be able to see and complete the lab form itself.

Figure 16-5 How a site user or data manager sees the new questions in a form

Already working in a live study?

As soon as the upgrade for this release is done, you can start using the new types of questions.

For an existing lab form, if you want to include the two new questions, access the study in Draft mode and edit the existing lab form. The two new questions appear as hidden. Turn off the Hidden toggle for the two new questions. After that, move the study version from Draft to Testing and test out the two new questions. If everything looks and works as expected, move the study version to Production. The two new questions will now appear in the new and live study version. For step-by-step instructions, see Create a new Draft version of a study to update the Approved version.

If the Sample Collection Date question is left unanswered, the system uses the visit start date to calculate the sample collection date of lab results. If the Fasting question is left unanswered, lab normals for Fasting will not be displayed in forms or reports.

For a new lab form, you will notice that the lab form already contains the two new questions. Finish defining all of the details of your new lab form and assign it to a visit. Once your study is tested in Testing mode and moved to Production mode, the lab form updates will be live.