Use Standards to Import a Custom Standard or Controlled Terminology, and Import a Standard from an MDR

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Within Standards, users can download a blank template based on the version of a specific standard (for example, CDASH, SDTM, ADAM, or DMOD) or controlled terminology. A full version of a standard or controlled terminology, including data, can also be downloaded, updated, and re-imported as a new custom standard.

For custom standards not associated with CDASH, SDTM, ADAM, or DMOD, a custom template is available for download. This custom template includes two tabs: one for the standard and one for controlled terminology.

Standards can also be imported from a configured standards data source, such as an MDR (Medical Data Repository) or OpenStudyBuilder (OSB) data source.

Default and custom standards are listed in the left navigation, commonly referred to as the Standards tree.

Download an Existing Standard

An Excel version of any available standard or controlled terminology can be downloaded. The exported file includes all associated data.

After updates are made, the Excel file can be re-imported as a custom standard or controlled terminology.

  1. Access Standards from the Platform Menu under Metadata Management.

  2. Click a version or controlled terminology associated with a standard in the left navigation. The selected version or controlled terminology displays.

    Standards page with the Standards tree in the left navigation and the selected standard version details

  3. Click the Export button. An Excel file containing the selected data downloads to the computer.

    The format for a standard is: Standard_Export_[standard]_[URL]_[DateTime].xlsx.

    The format for controlled terminology is: ControlledTerminologyExport.xlsx.

    For example, if SDTM 3.2 is selected, the name of the Excel file is Standard_Export_SDTM_URLxxx_20220321135554.xlsx.

    Standards page with the Export button for the selected standard version

Download a Standard Template

A generic standard template in Excel format can be downloaded for any available standard (for example, CDASH, SDTM, ADAM, or DMOD) or controlled terminology. The template can then be updated and imported as a custom standard or controlled terminology.

  1. Access Standards from the Platform Menu under Metadata Management. The available standards are listed in the left navigation.

  2. Click a version or controlled terminology associated with a standard in the left navigation. The selected version or controlled terminology displays, for example, SDTM 3.2.

    Standards page with the Download Template button for the selected standard version

  3. Click the Download Template button. An Excel template based on the selected version of the standard or controlled terminology downloads to the computer.

    The format of a standard template is: Standard_Template_[standard]_[URL]_[DateTime].xlsx.

    The format of a controlled terminology template is: ControlledTerminologyTemplate.xlsx.

    For example, if SDTM 3.2 is selected, the name of the Excel file is Standard_Template_SDTM_urlxxx_20220321114426.xlsx.

    Note: Each type of standard has different columns. For example, the columns in the CDASH template differ from those in the SDTM standard.

Download and Update a Custom Template

A custom template is also available, which includes one sheet for the standard and a separate sheet for controlled terminology. The template contains standard columns from SDTM, along with additional columns for ‘Field Length’ and ‘Significant Digits’. The template can be useful when validating external data.

Important: The sheet names Standard and Controlled Terminology must remain unchanged.

The template can then be updated and imported as a custom standard and controlled terminology.

Download Custom Template

Update the Custom Template

  1. Open the downloaded custom template. The template contains sample data in both sheets for reference.

  2. Update the Standard sheet.

    Standard sheet of the custom template with domain and variable columns and sample data

    COLUMN COLUMN NAME ENTRY DETAILS
    A Domain Name Enter the domain name. Must be unique within a standard.
    B Domain Label Enter the label of the domain.
    C Order Enter the order in which the variable name displays in the domain.
    D Variable Name Enter the variable name. Must be unique within a domain.
    E Variable Label Enter the variable label.
    F Prompt Enter the label of the domain.
    G Definition Enter the definition of the variable.
    H CodeList Enter the codelist name.
    I CRF Completion Instructions Enter the CRF completion instructions.
    J Information for Sponsors Enter the information for sponsors.
    K Core Enter Req, Exp, or No.
    L DataType Enter the data type, for example, Char, text, or integer.
    M Field Length Enter the field length based on the data type, for example, 200 for text and 8 for integer.
    N Significant Digits Enter the significant digits if the data type is float or decimal.

  3. Update the Controlled Terminology sheet.

    Controlled Terminology sheet of the custom template with codelist columns and sample data

    COLUMN COLUMN NAME ENTRY DETAILS
    A Code Must be a unique code for each Codelist Name in column D. This unique code connects the CDISC Submission Value (column E) for the Codelist Name (column D).
    B Codelist Code Enter the code from column A. Must be unique for the Codelist Name.
    C Codelist Extensible (Yes/No) Enter Yes or No.
    D Codelist Name Enter the codelist name.
    E CDISC Submission Value Enter the submission value.
    F CDISC Synonym(s) Enter the CDISC synonym.
    G CDSIC Definition Enter the CDISC definition.
    H NCI Preferred Term Enter the NCI preferred term.
  4. Save the custom spreadsheet.

Import a Customized Standard

Customized standards can be imported by uploading an Excel file for any of the available standards, or by importing directly from a configured standards data source, such as OpenStudyBuilder. For data source imports, refer to Import a Standard from an MDR Data Source.

Tip: The upload requirements depend on the selected Type:

  • CDASH, SDTM, or ADAM: Upload a separate file for the standard and for the controlled terminology. When uploading a controlled terminology file, select the Is Controlled Terminology checkbox. The template or revised exported file includes only the sheet for the selected standard or controlled terminology.
  • Custom: When uploading a custom standard template, select Custom as the Type. The custom template includes two sheets: Standard and Controlled Terminology. When Custom is selected, the Is Controlled Terminology checkbox is disabled.
  1. Access Standards from the Platform Menu under Metadata Management.

  2. Click a version or controlled terminology associated with a standard in the left navigation. The selected version or controlled terminology displays.

    Standards page with the Upload button for the selected standard version

  3. Click the Upload button. The Upload Custom Standard window opens.
    Upload Custom Standard window with the Type, Version, Is controlled terminology, Therapeutic Area Type, and Comments fields and the file drop area
  4. Click the Type drop-down and select the type of standard to import.
  5. In the Version field, enter the version name that displays in the Standards tree.
  6. Select the Is controlled terminology checkbox when uploading controlled terminology for a CDASH, SDTM, or ADAM standard type.
  7. In the Therapeutic Area Type field, enter the name of the therapeutic area to which the standard applies.
  8. In the Comments field, enter descriptive comments for the standard.
  9. Click the Choose File button, locate the file, and click Open, or drag the file to the Drop files here area.
  10. Click Import.

  11. The new standard displays at the bottom of the Standards tree, in orange, under a new Custom Standards heading.

    Standards tree with an imported standard listed under the Custom Standards heading

Manage Custom Controlled Terminology Versions

When multiple versions of controlled terminology exist for a custom standard, the Manage Versions button displays next to the Download and Download Template buttons. To identify which controlled terminology version is in view, check the Controlled Terminology Version field.

For example, the following screenshot displays the CT version CT for SDTM_ES within the folder structure Custom > SDTM > CT.

  1. Click the Manage Versions button. The list of versions displays.

    Custom controlled terminology with the Controlled Terminology Version field and the Manage Versions button

  2. To delete a version, click the Delete icon.

    Manage Versions list with the Delete icon for each controlled terminology version

Delete a Custom Standard

Default standards cannot be deleted; however, custom standards can be deleted if necessary.

  1. Access Standards from the Platform Menu under Metadata Management. The available custom standards are listed in the Standards tree.

  2. Click the custom standard to delete. Custom standards display in orange at the bottom of the Standards tree. The information for the selected standard version displays.

    Selected custom standard in the Standards tree with the Delete button

  3. Click the Delete button. A confirmation message displays.
  4. Click Yes to confirm the deletion or No to cancel. If confirmed, the standard is removed from the Standards tree.

Import a Standard from an MDR Data Source

If a standards data source, such as an MDR or OpenStudyBuilder (OSB) data source, is configured as a system data source, reference standards can be imported into Standards. Although data sources are typically defined at the study or global data store level, this type of data source is not associated with a specific study. As a result, it can be used across any study, global data store, or standards import.

Important: Only sponsor SDTM standards can be imported from OpenStudyBuilder. This is a limitation of the OpenStudyBuilder platform.

  1. Access Standards from the Platform Menu under Metadata Management.

    Standards page with the Import button for importing from a standards data source

  2. Click the Import button. The Import Custom Standard window opens.

    Import Custom Standard window with an OpenStudyBuilder data source selected and the Standard Versions drop-down

  3. Select an existing data source from the Data Source drop-down.

    Note: Only standards data sources, such as external MDR tools and OpenStudyBuilder connections, display in the list.

  4. Select the standard version from the Standard Versions drop-down. The list populates after a data source is selected.
  5. Click Import. A progress message displays while the standard data and then the controlled terminology are processed, followed by a completion message. The new standard displays at the bottom of the Standards tree under the Custom Standards heading.

Note: Standards imported from OpenStudyBuilder use the standard names defined in OpenStudyBuilder, including version details. Fields that have no corresponding value in OpenStudyBuilder, such as observation classes, are not populated. When CDISC notes are unavailable, the variable label is used.

Note: Standards imported from a data source can be exported to Excel, modified, and re-imported if needed. Modifying and re-importing the standard does not affect the original standard in the source system. Imported standards are available for standards-related activities, including data validation and mapping in tools such as Mapper, Validator, and Specifications.

Downloads

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