About managing code lists

Learn more about code list management for your study.

Code lists are predefined sets of data that serve as standard answer options, allowing study designers to apply them to drop-down, checkbox, or radio button type questions.

Static code lists

Users assigned the Manage Study Code Lists permission can access and modify a static custom code list by adding new items, hiding items, changing the order of values, updating the code, applying it to a new question, and applying it to an existing question that previously had the code list applied to it (if assigned the Design Forms permission, as well), even if the study design has already been moved to Approved.

  • The Value and Label for any code list item assigned to a question in an approved study version cannot be modified.
  • Any changes you make to a code list after you added it to a question have no impact on the original code list applied to the question. You can update an applied static code list via Advanced Study Versioning (ASV) or a Study Version change by modifying the code list and reapplying it to the question. If you make a change to a code list that was already applied to a question in a form, you need to re-add the code list to that question in order to see its changes reflected in the form.

    Note:

    You cannot change the type of code list (Static vs. Dynamic) as an ASV or Study Version change.
  • If a form that contains choice questions with associated static code lists is copied from another study or library, and the associated code list does not exist in your study, the code list name is not displayed with the question.
  • When you re-add a code list to a question, you must review any validation rules associated with the updated question to ensure they are not impacted or require modifications.

  • If you attempt to assign a code list to a question that is not the preexisting code list, the system displays the message alert:

    The following question is currently used in an approved study version. You can only modify and reload the existing custom code list for this question.

  • When the preexisting code list is applied to a question, the system displays the message:

    The following question is currently used in an approved study version. Any data previously collected will remain until updated by a system user.

  • You are required to review and update your study's randomization design or dose calculations if hidden code values are used in stratification, dose calculations, or cohort management.

    Note:

    When an updated static code list is applied to a question that is used as a branching question, none of the code list items can be hidden. Additionally, code values used in branching cannot be hidden.

  • Code lists also include standard codes for data analysis. To adhere to SDTM Controlled Terminology and follow the industry's standards, code lists must contain proper values. In turn, this allows statisticians to more easily analyze extracted data. For more information on data extracts, see the Subject Data Extract.

Dynamic code lists

Users assigned the Manage Dynamic Study Code Lists permission can create, update, and apply dynamic code lists to a question.

  • You can 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. For more information, see Map code list values to a site.
  • Dynamic code lists can be used in studies and libraries.
  • You can copy dynamic code lists from one study to another.
    • 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.
    • 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.

    For more information, see Copy a code list.

  • 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.
  • The dynamic feature cannot be applied to Safety and Test tagged code lists, custom enrollment groups, reconciliation forms, or questions designed to import Electronic Health Records (EHR) data.
For more information and step-by-step instructions for managing code lists, see:

Parent topic: Code lists