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 (e.g., 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 to 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.

Another option is to import a standard from a configured MDR (Medical Data Repository) 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 from the left navigation. The selected version or controlled terminology displays on the right.

    Standards

  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 was selected, the name of the Excel file would be: Standard_Export_SDTM_URLxxx_20220321135554.xlsx.

    Export Standard

Download a Standard Template

A generic standard template in Excel format can be downloaded for any available standard (e.g., 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 at the left of the window.

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

    Download Standard Template

  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 was selected, the name of the Excel file would be: 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.

    Custom Standard

    Column Column Name Entry Details
    A 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 should appear in the domain
    D Variable Name Enter the Variable Name and 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 CodeList name
    I CRF Completion Instructions Enter CRF Completion Instructions
    J Information for Sponsors Enter Information for Sponsors
    K Core Enter Req/Exp/No
    L DataType Enter Char / text / integer / etc.
    M Field Length Enter field length based on DataType, i.e., 200 for text, 8 for integer
    N Significant Digits Enter signification digits if DataType is float/decimal

  3. Update the Controlled Terminology sheet.

    Custom Controlled Terminology

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 Code from Column A and unique for CodelistName
C Codelist Extensible (Yes/No) Enter Yes or No
D Codelist Name Enter Codelist Name
E CDISC Submission Value Enter Submission Value
F CDISC Synonym(s) Enter CDISC Synonym
G CDSIC Definition Enter CDISC Definition
H NCI Preferred Term Enter NCI Preferred Term

4. Save the custom spreadsheet.

Import a Customized Standard

Customized standards can be imported using the Excel format for any of the available standards, simplifying the customization process. 

Tip: Uploading a custom standard when Type is CDASH, SDTM, or ADAM - When uploading an Excel file for a specific standard or controlled terminology type (e.g., CDASH, SDTM, or ADAM), a separate file must be uploaded for the standard or 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.
Uploading a custom standard when Type is 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 and cannot be selected.

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

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

    Upload Standard

  3. Click the Upload button. An Upload Custom Standard window opens.
    Upload Custom Standard Window
  4. In the Type field, click in the drop-down and select the type of standard being imported.
  5. In the Version field, enter the version name to be displayed in the Standards tree.
  6. Select the Is controlled terminology checkbox if uploading a custom controlled terminology for a standard / custom CDASH, STDM, 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 available standards in the Standards tree. It displays in orange under a new Custom Standards heading.

    Custom Standards

Manage Custom Controlled Terminology Versions

When multiple versions of controlled terminology for a custom standard exist, the Manage Versions button displays at the top right (next to Download and Download Template). To identify which version of the controlled terminology is currently in view, refer to the top-left area and the Controlled Terminology Version field. 

For example, the screenshot below is displaying 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.

    Manage Versions

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

    Delete

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 be deleted. Custom standards appear in orange at the bottom of the list. This displays the information for the selected standard version.

    Delete Custom Standard

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

Import a Standard from an MDR Data Source

If an MDR data source has been configured, reference standards can be imported into the Standards module. 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.

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

    Import MDR Data Source

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

    Import Custom Standard

  3. In the Data Source field, select an existing data source from the drop-down list.

    Note: Only data sources from external MDR tools display in the list.

  4. In the Standard Versions field, select the standard version from the drop-down list.
  5. Click Import. The new standard displays in the Standards tree at the bottom of the panel under a new Custom Standards heading.

Note: These MDR Standards can be exported to Excel, modified, and re-imported if needed. Modifying and re-importing the standard does not affect the original MDR standard.

Downloads

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