Create and manage code lists for all studies at your organization

Sponsor users and CROs now have dedicated spaces within the application to manage their code lists for a single study or all studies at an organization.

You can now create your very own library of code lists! By organizing your default and custom values, you offer all sponsor users at your organization the ability to effectively manage their own data library. For example, if your organization conducts a pediatric study and an oncology study, both groups of sponsors may need to use very different values within each study. This is where the library of code lists comes in handy. Having a set of default code list values and the ability to customize those values at a study level gives you the perfect blend of data consistency and integrity, and data customization across studies.

Before you work with this feature

This new feature can impact most study team members. The following users can manage code lists:

• The study designer, as long as they are assigned with the Manage Study Code Lists permission. Study designers can only manage code lists that are used in form design.
• Any user at a sponsor or CRO who is assigned the new Codelist Manager global role.

Details about system code lists and the global library of code lists

Here's what's new for you, as a code list manager:

• On the homepage, there is a new page called Library.
• The Library page is where you can create a global library of code lists that can be used across multiple studies at your organization.
• On the Library page, code lists are organized by groups: custom code lists and system default code lists. The system default code list group contains predefined code lists created by Oracle and you will see them on the User Interface (UI). The custom code list group contains all code lists that can only be used for form design or study filters. For more information on study filters, see Order studies using the company filters.
• The system default code list group contains code lists that exist in the system, by default. You can view and edit certain details of these default code lists, but you cannot delete them or create new ones. You can create new system code list groups, but those will only contain the default code lists (also included in the default group of code lists). You can edit certain elements of the code lists included in a system code list group that you've created yourself.
• The custom code list group contains all code lists that you create from scratch and that you can view and further edit. You can hide values in a custom code list, create new values in a code list, or create a new code list in the custom code list group.
• Code lists can be created in all languages available in the application. Upon selecting a code list, you can view the code list items by switching between language tabs in the library.
• Upon creating a study, you should assign a system code list group to that study. This way, your study uses the appropriate group of code values. You also have the option of assigning a system code list group to a study at any time during the study's development, whether it's during the design phase, the testing phase, or the conduct period of a study.

Figure 7-1 Access the Library

Figure 7-2 Create a system code list group

Details about study code lists and a study's individual library

Here's what's new for you, as a study designer who creates and manages code lists at a study level only:

• As a study designer, you can continue creating code lists specific for designing forms. A code list that can be used in form design can be found in the custom code list group on the Code list tab in a study's settings.
• All code lists in a single study can now be managed in a study's settings, on the new Code List tab. You can either edit certain elements in a code list from the system default code list group or you can create or delete a custom code list in the custom code list group.
• on the Code list tab, if you create a new custom code list, that newly-created custom code list is not available for all studies at your organization. If you edit elements of any system default code lists (from the system default code list group), these edits will only be available in the context of a single study.
• When new system code list groups are added at a global level (on the Library page), these new code list groups are also displayed on the Code List tab in the context of a single study.

Figure 7-3 Create a custom study code list

Already working in a live study?

As soon as the upgrade for this release is complete, you can begin creating and managing code lists for specific studies or all studies at your organization. For existing studies, you can continue using the custom code lists you have created for form design and you do not have to update these code lists to accommodate the new feature. All of the existing custom code lists that were previously created for form design will now show up on the Code List tab for every study.

To assign a system code list group to an existing study, you can edit the study's details on the General tab, and select the appropriate system code list group to assign to that study.

Note:

When you attempt to update the custom code list called EDCYearRange, you may experience some unexpected behavior related to how labels are updated. This Known Issue may potentially impact the way partial dates are defined in a form. For more information, see issue 34783476 in the Known Issues List.