Users have the ability to create, edit, and manage specifications. This includes selecting domains, variables, and codelists for each specification.

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 list. Only studies accessible to the current user are displayed. This is a required field.
6. Select the Type from the drop-down list: Mapping or Exception Listing.
7. If Mapping is selected as the Type:

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

      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 number from the drop-down list. Available options are determined by the selected Standard.
   3. Select the Controlled Terminology Version number from the drop-down list. Available options are determined by the selected Standard and Standard Version. A message displays if a controlled terminology version is required for the selected standard.
   4. Select the Therapeutic Area from the drop-down list.
   5. Select the Dictionary version from the drop-down list  (i.e., MedDRA version).
   6. Select the Drug Dictionary version from the drop-down list (i.e., WHO Drug version).
8. Enter the Version Name.
9. Enter any appropriate Notes.
10. Select the Requires Domain Approval checkbox if each domain must be approved individually for the specification to be approved.
11. Click Save.

After saving the new specification, it is listed at the top of the list due to the default sorting by the Last Changed column and automatically marked as Active. The Methods page also has 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 in the Specifications section.

Generate an SDTM Mapping Specification with AI

To save users manual effort and time when creating an SDTM Mapping Specification, elluminate's AI can automatically define target domains and variables in the Variables List Source Field.

Important: To configure and use Specification Automation, the machine learning model must first be enabled for the URL. Contact your eClinical Solutions representative for more details.

Configure Specification Automation

1. Within the Platform Menu under Platform Administration, select Configuration.

2. Create a new tag called SpecificationAutomation.

   Note: This step only needs to be completed once for the URL, if the tag already exists skip to step 3.

3. Within the Platform Menu under Metadata Management, select Metadata.
4. Choose the desired study from the Study drop-down.
5. For the Data Store(s) the model should run on, in the Tag column for the corresponding row, apply the SpecificationAutomation tag.

6. To trigger the model, run a data import for the data store(s). The model must run for several minutes before it is ready to use.

   Note: Imports that cause a metadata change in the tagged data store triggers the model to run automatically.

Run Specification Automation

To utilize the model, create a new SDTM mapping specification following the Create New Specification instructions. Once the specification is created, users see a list of Domains based on the selected Standard version.

In the Variables List for the generated Domains, the Source Field column is auto-populated.

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

Edit a Specification

1. Locate the specification to edit and select the record by clicking the row or checking the checkbox to the left.
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 the necessary updates. All fields are editable except the specification type.
4. Select Save to apply the changes.
   

Manage Specification Details

1. Locate the specification to edit and select the record by clicking the row or selecting the checkbox to the left.
2. Click the Details icon in the toolbar to open the Details window opens on the right side of the screen:
   • Click the Edit icon in the top right to edit the specification.
   • Click the x in the top right to close the Details window.
   • Click the arrow on the left to expand each section and view Domains, Codelists, or related Issues.
   • Blue badges next to Domains and Codelists indicate the number of domains and codelists added to the specification. Next to Issues, the red badge indicates the number of open issues, and the green badge indicates the number of answered, closed, and canceled issues.
   • Click the Go to Domains, Go to Codelists, or Go to Issues buttons to navigate directly 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 checkbox to the left of the specification, or right-click the record.
2. Click the Change Status icon in the toolbar, or right-click a row and select Change Status.
3. Select the desired status from the drop-down list.