Specifications can be created, edited, and managed to define domains, variables, codelists, and methods. Specifications can be created manually or generated using Mapping Automation. When Mapping Automation is configured and data is imported and processed, elluminate automatically generates domains, variables, and Source Field mappings for SDTM specifications.

Create a New Specification

To create a specification, a name must be entered, a study selected, and a specification type chosen. Specification attributes can optionally be defined. If a standard is not selected during creation, it can be assigned later on the Domain page. Specification attributes can be edited at any time during the development process. After the specification is created, navigate to the Domain page to select domains for inclusion in the specification.  

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

2. Click the Add icon in the toolbar.
   The Create Specification window opens. Fields with an asterisk are required.

   

3. Enter the Name of the specification. This is a required field.
4. Enter a Description of the specification.
5. Select the Study from the drop-down. Only studies accessible to the current user are displayed. This is a required field.
6. Select the Type from the drop-down: Mapping or Exception Listing.
7. If Mapping is selected:

   1. Select the Standard from the drop-down: ADAM, CDASH, Custom, or SDTM.

      Important: If SDTM is selected and Mapping Automation is enabled with configured data stores and completed data processing, the specification is automatically generated using AI. Domains, variables, and Source Field values are created based on the selected standard and imported data. 

      Note: If a standard is selected during specification creation, domains can be selected only from that standard and version. To select domains from multiple standards, leave this field unselected. 

   2. Select the Standard Version from the drop-down. Available options are based on the selected standard.
   3. Select the Controlled Terminology Version from the drop-down. Available options are based on the selected standard and version. A message displays if required.
   4. Select the Therapeutic Area from the drop-down.
   5. Select the Dictionary version from the drop-down (i.e., MedDRA version).
   6. Select the Drug Dictionary version from the drop-down (i.e., WHO Drug version).
8. Enter the Version Name.
9. Enter Notes, as needed.
10. Select the Requires Domain Approval checkbox if domains must be approved individually for the specification to be approved.
11. Click Save.

After saving, the specification displays at the top of the list based on the default sort by Last Changed and is marked as Active. The Methods page includes a default list of mapping methods used for SDTM and ADaM data transformations.  

Note: For details on managing Methods, see the Manage Methods in Specifications article.

Generate a Specification with Mapping Automation

Mapping Automation uses AI to generate domains, variables, and Source Field mappings for SDTM specifications.

This feature supports SDTM standards only.

Important: To configure and use Specification Mapping Automation, the Allow Specifications > Allow Mapping Automation URL setting must be enabled. Contact an eClinical Solutions representative for more details.

Configure Mapping Automation

1. From the Study Details page, click the configuration icon to open the Edit Study window.

2. Go to the Settings tab.

   

3. Enable the Statistical Computing Environment (SCE). 
4. Enable Mapping Automation.
5. Select the Source Data Store(s) the model runs on by clicking in the field and selecting from the list.
6. Click Save.

After configuration:

7. Run a data import for the selected data store(s) to trigger the model.

The model runs for several minutes. When processing is complete, Mapping Automation is ready for use.

Note: Imports that introduce metadata changes in the selected data stores automatically trigger the model to run.

Tip: An audit log entry displays with the status Update Completed when processing finishes. This indicates the model is ready for use.

Mapping Automation

After data is imported into the selected data stores, the AI model runs automatically. When processing is complete, the model is ready for use.

To generate AI-enhanced specifications:

1. Create a new specification and select SDTM as the standard.
   
2. Complete the specification setup.

After the specification is created:

• The Domains list displays domains based on the selected standard version.
• The Variables list is generated for each domain.
• The Source Field column is automatically populated for applicable variables.
  

Important: When SDTM is selected, Mapping Automation generates the specification based on the configured model output. 

The AI-generated results can be modified or replaced as needed.

Note: Double-click any cell in the Variables list to edit values directly in-line. To view full variable details, select the row and click the Details icon on the toolbar. For more information, refer to the Manage Domains and Variables in Specifications article.

Edit a Specification

1. Select the specification by selecting the row or the checkbox next to the specification.
2. Click the Edit icon in the toolbar, or right-click the record and select Edit. The Edit Specification window opens with the current specification attributes.
3. Make updates as needed. All fields are editable except the specification type.
4. Select Save to apply the changes.
   

Access Specification Details

1. Select the specification by selecting the row or the checkbox next to the specification.
2. Click the Details icon in the toolbar. The Details view opens to the right.
   • Click the X in the top right to close the Details view.
   • Click the arrow to expand each section and view Domains, Codelists, or related Issues.
   • Blue badges next to Domains and Codelists indicate the number of items added. For Issues, the red badge indicates open issues, and the green badge indicates answered, closed, and canceled issues.
   • Click Go to Domains, Go to Codelists, or Go to Issues to navigate to the corresponding area.

Update the Status of a Specification

A specification defaults to the status of In Development. Use the Change Status icon to update the status as the specification progresses through review and approval cycles. To edit a specification, the status must remain In Development.

1. Select the specification by selecting the checkbox next to the specification, or right-click the record.
2. Click the Change Status icon in the toolbar, or right-click the row and select Change Status.
3. Select the desired status from the menu.