Within Standards, users can easily download a blank template based on the version of a specific standard (i.e., CDASH, SDTM, ADAM), or controlled terminology. Users can also download a full version (with data) of a standard or controlled terminology, update it, and then re-import as a new custom standard.

For a custom standard not associated to CDASH, SDTM, or ADAM, 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 standards and custom standards are listed in the left navigation. This is often referred to as the Standards tree.

Download an Existing Standard

You can download an existing standard CDISC Excel format for any of the available standards or controlled terminology. Exporting an existing version of a standard or controlled terminology includes all the data.

The exported Excel file can be easily updated and then re-imported as a custom standard or controlled terminology.

1. Access Standards from the Platform Menu under Metadata Management.
2. Click on a version or Controlled Terminology of a Standard. The version or controlled terminology of the selected standard displays.
3. Click the Export button. An Excel file based on your selection downloads to your 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.
   

Download a Standards Template

You can download a generic standard template in CDISC Excel format for any of the available standards (e.g., CDASH, SDTM, ADAM) and 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 on a version or Controlled Terminology of a Standard (for example, 3.2 for SDTM). The version or controlled terminology of the selected standard displays.
   
3. Click the Download Template button. An Excel template based on the selected version of the standard or controlled terminology downloads to your 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 are different than the columns in the SDTM standard.

Download and Update a Custom Template

Also available is a custom template that includes a sheet for the Standard, and a sheet for Controlled Terminology. The custom template includes standard columns (from SDTM), plus columns ‘Field Length’ and ‘Significant Digits.’ This custom template can be helpful when validating external data.

Important: The names of the sheets, Standards and Controlled Terminology must not be modified.

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 your reference. 
2. Update the Standard sheet.
   
   
   

   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.
   

4. Save the custom spreadsheet.

Import a Customized Standard

You can import a customized standard from a CDISC Excel format for any of the available standards, this can make it easier to customize. 

Tip: Uploading a custom standard when Type is CDASH, SDTM, or ADAM - When uploading an Excel file for a specific type of standard or controlled terminology (e.g., CDASH, SDTM, or ADAM), a separate file for the standard or controlled terminology must be uploaded. When uploading a controlled terminology file, you must check the Is Controlled Terminology box. This is because the template or revised exported file only includes the sheet for the standard or controlled terminology.
Uploading a custom standard when Type is Custom - When uploading a Custom Standard Template, you must be sure to select Custom as the Type. This is because the Custom template has two sheets, Standard and Controlled Terminology. Also, when Custom is selected as the type, the Is Controlled Terminology checkbox becomes grayed out and you are unable to check the box.

1. Access Standards from the Platform Menu under Metadata Management.
   
2. Click on a Standard. This displays the information for the version of the selected standard.
3. Click the Upload button. An Upload Custom Standard window opens.
   
4. In the Version field, enter the version name you want the standard to be listed as in the Standards tree.
5. Select the checkbox for Is controlled terminology if you are uploading a custom controlled terminology for standard/custom CDISC, STDM, or ADAM standards type.
6. In the Therapeutic Area Type field, enter the name of the Therapeutic Area the standard related to.
7. In the Type field, click in the drop-down and select the type of standard you are importing.
8. In the Comments field, enter descriptive comments for the standard.
9. Click the Choose File button, find your file and click Open, or Drag the file to the Drop files here space.
10. Click Import.
11. The new standard displays at the bottom of the available standards in the Standards tree. They are in orange and listed under a new Custom Standards heading.
    

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 the controlled terminology in view, look to the top left and in 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.
   
2. To delete the version, click on the Delete icon (trashcan). 
   

Delete a Custom Standard

Default standards cannot be deleted; however, you can delete a custom standard if necessary.

1. Access Standards from the Platform Menu under Metadata Management. The available custom standards are listed at the left of the window.
2. Click on the custom standard to be deleted, they appear in orange at the bottom of the list. This displays the information for the version of the selected standard.
   
3. Click the Delete button. A confirmation dialog box opens.
4. Click OK. The standard will be removed from the list.

Import a Standard from an MDR Data Source

If an MDR Data Source has been configured, you can import the reference standards into the Standards module. Although data sources are defined at the study or global data store level, this data source type is not associated with a particular study, so it can be used within any given study, global data store, or standards import.

1. Access Standards from the Platform Menu under Metadata Management.
   
2. Click the Import button. An Import Custom Standard window appears.
   
3. In the Data Source field, select an existing data source from the list.
   

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

4. In the Standard Versions field, select the standards to import.
5. Click Import. The new standard will display at the bottom of the panel at the left under a new Custom Standards heading.

Note: These MDR Standards can then be exported to Excel, modified, and re-imported if necessary. Modifying the standards and re-importing will not have any effect on the original MDR standard.

Downloads

• Standard_Template_Custom.xlsx20 KB