Manage dynamic code lists

Now, dynamic code list types allow study designers to add code list options without requiring a Study Version or an Advanced Study Version change, while also being able to control which values in a code list are visible to a user based on the site.

Before you work with this feature

Study designers assigned the new Manage Dynamic Study Code Lists permission can create, update, and apply dynamic code lists to a question. Additionally, users with this permission can select any site in any mode while creating the code list.

More information on this permission can be found in the Notifications and Permissions Guide after the upgrade.

Details for study designers and other sponsor users

As a study designer, here's what's new for you:

  • You can now associate a dynamic code list to a choice question and see the changes reflected on the form immediately once the question has been moved to the respective mode. Any changes made to the code list are applied to it in all modes once saved.
  • By default, all values are shown in the code list. If one or more sites are specified for a particular mode, the code list is filtered so that the option is available only for subjects at the specified site(s) for that mode.

    Note:

    Site specifications apply only to dynamic code lists.
    • Any changes you make to the code list row is applied to all associated sites.
    • A site must be created in the required mode (Training, Testing, or Production) before code list values can be mapped to it.
    • A selected site that is later retired still displays in the code list, but cannot be selected once retired.

      Note:

      The system generates the following warning when a retired site is selected and additional code list values are changed, as well:

      Site [ID] is retired and will be removed where it was previously selected. If no other sites have been selected for the code list option, it will be set to "All Sites."

  • Dynamic code lists can be used in studies and libraries.
  • You can copy dynamic code lists from one study to another by using download and import.
    • To copy a study that includes one or more dynamic code lists, the user's role in the source study must include the Manage Dynamic Study Code Lists permission.
  • You can copy forms from one study to another that contain dynamic code lists.
    • The user's role in the targeted study must be assigned the Manage Dynamic Study Code Lists permission to copy a form from another study or library that includes one or more dynamic code lists.
  • All values of the dynamic code list are passed to a signature configuration, regardless of any site associations that may be specified for the code list option.
  • A value that is later hidden in the code list that was previously selected by the site remains stored as the selection by the site until the site updates the question value and the changes are saved; the value is then faded, moved to the top of the list, and removed from their selection.
  • This functionality does not apply to Safety and Test tagged code lists, custom enrollment groups, reconciliation forms, and Electronic Health Records (EHR).
  • The new Last Modified Date (UTC) column on the Code List page provides details on when the code list was last updated.

Note:

When working with dynamic code lists in integrated studies, be aware that some systems may not support this feature.

More information and step-by-step instructions on managing dynamic code lists can be found in the Study Designer User Guide after the upgrade completes.

Impact on reports, extracts, archives, or datasets

Report or archive Type of change Description
Study Design report Modified column data The List of Values column now indicates when a code list is dynamic, with a value of Dynamic Code List.
Annotated Case Report Forms Modified column data The Answer column now indicates when a code list is dynamic, with a value of Dynamic Code List.
Study Codelist dataset (Codelists folder) New and modified column data The following updates have been made to this dataset for dynamic code lists:
  • The new column, CODELIST_MODE, indicates the mode in which the associated site was created (Training, Testing, Active).

  • The new column, SITE_ASSOCIATION, indicates which sites in that mode the code list option is mapped to with a value of either ALL SITES or an alphabetical list of the sites based on site ID.

    Note: This field only populates for CODELIST_LEVEL = study.

  • The new column, LOCALE, indicates the selected code list language.

    Note: This value displays as NULL for static code lists.

  • The CODE_LEVEL column indicates whether a code list is dynamic or static with either a value of DYNAMIC or STATIC.
Study Design dataset (Items folder) New and modified column data
The following updates have been made to this dataset for dynamic code lists:

  • The new column, CODELIST_LINK_TYPE, indicates whether choice questions are DYNAMIC or STATIC.

    Note: This value displays as NULL for non-choice questions.

  • The CODELIST_VALUES and ITEM_VALUES fields populate as NULL because no code list values are stored in the form for dynamic code lists.

More information can be found in the Analytics User Guide and Reporting Guide after the upgrade completes.

Already working in a live study?

Once the upgrade completes, you can begin creating and using dynamic code list options in new and existing studies. Existing code lists are defaulted to a Static type, requiring a study version change to make updates. The initial creation of the question and code list association to the question requires a Study Version or ASV change; once the question - with the associated code list - exists in the respective mode, changes can be made to the code list options.

Parent topic: Study design