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Add codelist

A codelist is a predefined list of standardized codes representing specific responses or data points. The codelists are essential in the CRF design as they ensure consistency in data collection, making the data comparable across different subjects or time points.

By adding codelists to the SD app, you predefine a database of such lists for the CRF design, where you can reuse them. You can add as many codelists as needed to ensure they are comprehensive, accurate, and tailored for the data collection according to the specific study requirements.

In SD, there are multiple ways of adding codelists as discussed in the following sections.

Add codelists from library

By adding codelists to your study in the SD app, you predefine a database of such lists for the CRF design, where you can reuse them. One of the ways to add codelists is to import them from the local library. The library contains the latest version of the CDASH SDTM standard, providing access to the most current codelists, complete with corresponding code items. This library is available for all your studies handled via SD, so you can add and reuse the same codelists to any study, maintaining cross-research consistency and up-to-date standardization.

Important

Before initiating the following procedure, ensure to select the latest unlocked CRF version from the toolbar of the CRF DESIGN tab, otherwise, you cannot add codelists to your study. The CRF version remains unlocked until it is submitted to EDC for data entry.

To add codelists from the library

  1. In the Study Designer application header, select the CODELIST tab.

  2. From the workspace toolbar of the CodeList Setting table that appears, select the library icon icon_library.png.

    Accessing codelist library
    Figure 1. Accessing codelist library

  3. On the page that opens, select the codelists you want to add to your study. You can navigate between pages or use the filters to locate and select needed codelists.

    Selecting codelists to add
    Figure 2. Selecting codelists to add

  4. From the workspace toolbar, select save_button_red_white.png.

Once saved, the selected codelists are added to your study. You can now associate these codelists with question responses in forms.

Import codelists

By adding codelists to your study in the SD app, you predefine a database of such lists for the CRF design, where you can reuse them. One of the ways to add codelists is to import them from your computer in the XLSX format. To ensure that the file structure is supported by the application, you can export the codelist template beforehand and fill it out. This guarantees the file's compatibility with the system.

Important

Before initiating the following procedure, ensure to select the latest unlocked CRF version from the toolbar of the CRF DESIGN tab, otherwise, you cannot add codelists to your study. The CRF version remains unlocked until it is submitted to EDC for data entry.

Moreover, make sure that the file contains unique codelists that have not yet been added to your study. The system prevents the import if the file includes existing codelists.

To import codelists

  1. In the Study Designer application header, select the CODELIST tab.

  2. From the workspace toolbar of the CodeList Setting table that appears, select Import import_icon.png.

    Accessing codelist import
    Figure 1. Accessing codelist import

  3. In the dialog that appears, follow the prompts of your operating system to locate and select the needed file.

Once imported, codelists from the selected file are added to your study. You can now associate these codelists with question responses in forms.

Add codelist manually

By adding codelists to your study in the SD app, you predefine a database of such lists for the CRF design, where you can reuse them. One of the ways to add codelists is to create them manually. This method is useful when your research requires the collection of study-specific data that is not covered by codelists added from the local library. The manual creation of codelists ensures that the unique data requirements of your study are met.

Important

Before initiating the following procedure, ensure to select the latest unlocked CRF version from the toolbar of the CRF DESIGN tab, otherwise, you cannot add codelists to your study. The CRF version remains unlocked until it is submitted to EDC for data entry.

To add a codelist manually

  1. In the Study Designer application header, select the CODELIST tab.

  2. From the workspace toolbar of the CodeList Setting table that appears, select New Code icon_add_plus.png.

    Accessing option to add codelist manually
    Figure 1. Accessing option to add codelist manually

  3. In the Add dialog that appears, fill in the fields as explained in the following table.

    Adding codelist manually
    Figure 2. Adding codelist manually

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Name*

    Enter the unique name of the codelist.

    Data Type*

    Select the category of data depending on what type of response the codelist is expected to include, such as:

    • Text: the codelist items are to be in textual format.

    • Number: the codelist items are to be in numerical format.

    Display as Image

    Select this checkbox if you want the items of the codelist to include images. By selecting this checkbox, you enable the functionality to upload logo images to each codelist item. If cleared, you cannot add images to codelist items.

    SAVE

    Select save_button_red_white.png to create a codelist.

Once saved, a new codelist is added to your study. You can now add items to this codelist.

In this section:

A predefined list of standardized codes representing specific responses or data points, ensuring consistency in data collection, making the records comparable across different subjects or time frames. In eClinical, codelists are configured in multiple apps for further reuse in various form designs, such as case report forms (CRFs) in SD, trip report forms in CTMS, and so on.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

A model describing the foundational structure for the organization, naming, and description of variables and associated attributes to support data collection in clinical trials. CDASH establishes a standard way to collect data consistently across studies and sponsors so that data collection formats and structures provide clear traceability of submission data into the Study Data Tabulation Model (SDTM), delivering more transparency to regulators and others who conduct data review.

A standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).