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. When it comes to managing code lists, consider the following:
  • Users assigned the Manage Study Code Lists permission can access and modify a custom code list by adding new items, hiding items, changing the order of values, updating the code, 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. For more information on custom code lists, see Create a custom code list.
    • 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. This is because the applied code list is directly associated to the question and stored with 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.
    • 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 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 codes. In turn, this allows data managers and statisticians to more easily analyze extracted data. For more information on data extracts, see the Subject Data Extract.

For more information and step-by-step instructions for managing code lists, see:

Parent topic: Code lists