Enhancements to local labs

Study designers can now let site users enter more than one instance of a lab form at a visit.

Note:

This enhancement only applies to lab forms.

Details for study designers

If you're a study designer, here's what's new in your workflow:

• In a lab form, the Details side panel now displays a new toggle called Allow for Multiple Instances. By default, this toggle is turned off.
• When you turn the Allow for Multiple Instances toggle on, you let a site user enter more than one instance of the same lab form during a visit.
• From now on, you can also hide all questions in the Questions Before the Table section, configure, associate lab results to other forms using Link & Show rules, and only configure the following predefined rules: Show Question and Show Section.
• Moreover, for a lab form the Repeating Form toggle is turned on by default and inactive, while the Allow Additional Rows toggle is turned off by default and active.

Details for site users

If you're a site user collecting lab data, here's what's new in your workflow:

• If you're allowed to add additional instances of a lab form to a subject's visit, you can click Add () next to the title of a lab form to include a new instance of the same lab form. Or you can click Add next to the lab form's title.
• For each lab form instance you add, you must do the following:
  • Select a lab from the Select Lab drop-down so you can collect data associated with the appropriate lab.
  • Collect data for the Sample Collection Date and Fasting questions.

Impact on reports

The following reports and extracts are impacted:

• The Annotated Case Report Forms includes the text Allow for Multiple Instances in the header of each lab form that is configured this way.
• The Study Design report includes a new column called Allow for Multiple Instances for each lab form. The column displays No or Yes, depending on whether that toggle is turned on or off in a lab form.
• When additional instances of a lab form are included in a study, the following REPEATNUMBER column in the Subject Data Extract will display a lab form's instance number.
• In Oracle Clinical One Analytics, the Study Design dataset will display the Allow for Multiple Instances design setting. The Subject Form Items dataset will display additional instances of a lab form.

Impact on custom rules

You can use custom rules to compare data between instances of a lab form in the same visit. Moreover, because a lab form now works as a two-section form, you can also start using the same rule helper functions that are available for two-section forms.

Impact on integrations

When it comes to Oracle CRF Submit, you can learn more about the impact on this integration type in our Release Notes. For more information, see Enhancements to Oracle CRF Submit archives and reports.

Already working in a live study?

As a study designer, you can update existing lab forms to let a site user enter additional instances of a lab form at a visit through a study version change. This update is not supported through Advanced Study Versioning (ASV).

More information about this feature can be found in the following user guides, after the Release Assessment Environment (RAE) upgrade:

• Study Designer User Guide
• Site User Guide
• Reporting Guide