Permissions: Users can view and access Specifications for studies for which they have the appropriate permissions.
Introduction to Specifications
A Specification is a document containing a set of rules and definitions that define how a study's imported source data should be transformed to meet a selected CDISC standard, a custom standard, or a listing format.
Specifications is a tool for creating, editing, versioning, and tracking the workflow of a study's specifications. Once created, specifications are used in Mapper to transform data for dataset mapping or exception listings.
Some of the key features of Specifications are:
- Specifications can be linked to a study in Mapper for domain- and variable-level guidance, including field names, data types, labels, codelists, and mapping recommendations, helping users map domains and variables to the target format.
- Specifications include built-in workflow and version control, enabling users to advance specifications through development, review, and approval while tracking all changes.
- Mapping Automation can automatically generate domains and variables for SDTM specifications when AI is enabled, Mapping Automation is configured, and applicable study data are available.
- Mapping Automation can provide AI-generated recommendations for Source Field, Mapping Method, and Mapping Arguments in SDTM specifications. Recommendations can be reviewed, accepted, rejected, or updated within the Variable List. Mapping Automation activity is tracked through audit logging.
- Export specifications as Excel spreadsheets, XML files, or XSL stylesheets for sharing, archival, or integration with other tools.
Access Specifications
Specifications are accessed from the Platform Menu.
By default, when Specifications is selected from the Platform Menu, the listing opens with a filter applied to display only active specifications. The blue badge indicates the number of specifications listed with applied filters. The Filters icon indicates that filters are applied, and the filtered column header displays a Filter icon. To view all the specifications, clear the filter.
Tip: Other columns can be filtered. For example, the view can be limited to display only Mapping specifications or those associated with a specific Standard.
Specifications functionality is consistent with other elluminate products. Columns can be sorted, filtered, and fixed to the left or right. Filtered and sorted columns are retained when navigating between panels. Individual specifications can be selected for editing, copying, approval, deletion, or export.
Specification Listing Columns
| COLUMN | DETAILS |
|---|---|
| Open Issues | The number of open issues within the specification. The number is a hyperlink that opens a list of the open issues that can be managed. |
| Name | The name of the specification is an active hyperlink to the next level in the selected specification type. |
| Type | The type of specification, such as Mapping or Exception Listing. |
| Study | The study name. |
| Standard | The standard used in the specification. |
| Standard Version | The version of the standard used in the specification. |
| Active | If selected, the specification is in active development or use in production. Users can change the Active flag at any time. Users can view deactivated specifications by adjusting the filter on this column. |
| Version | The system version number has a hyperlink to the version history. |
| Version Name | An alphanumeric field for a custom version name can be entered any time. |
| Status | Displays the current status of the specification, such as In Development, Submitted for Review, Submitted for Approval, Approved. |
| Requires Domain Approval | If selected, the specification type requires domain-level approval. Each domain is approved independently. The specification can move to Approved status only when all domains are approved. This allows programming to begin on approved domains before the entire specification is complete. |
| Approved Version | The version number of the most recent approved version of the specification. If no approved version exists, the column is left blank. |
| Last Approved Date | The modified date of the last approved version. If no approved version exists, the column is blank. |
| Last Changed | The date and time of the last update made to the specification. This column is sorted by default, so the most recently updated specifications are at the top. |
Toolbar Icons and Actions
Use toolbar actions to manage specifications. Select one or more rows by clicking a record row or selecting the checkbox to the left of each row.
| BUTTONS / ICONS | ACTION |
|---|---|
| Domains | Select the Specification, then click Domains to view the list of domains included in the specification. |
| Codelists | Select the Specification, then click Codelists to go to the list of codelists included in the specification. |
| Methods | Select the Specification, then click Methods to navigate to the list of methods included in the specification. |
| Change Status | Select the Specification, then select a status from the drop-down. The current status is unavailable. Available statuses include: In Development, Submit for Review, Submit for Approval, Approve. |
| Attachments | Select the Specification, then click Attachments to Upload Annotated CRF, Upload Supporting Doc, or Manage Documents. |
| Add | Create a new specification. |
| Edit | Edit the selected specification. |
| Create New Version | Select an approved specification, then click Create New Version to create a new version of the selected specification. |
| Details | Select a specification, then click Details to open the Details panel. |
| Issues | Click Issues to create or view issues. |
| Export | Click Export to open a drop-down menu with options: Pinnacle 21 Format, ECS Format (Separate Domain Tabs), ECS Format (Variables on Single Tab), Define.XML, or Define2.0 XSL. Note: Define.XML exports include Methods and VLM information. |
| Deactivate | Select the specification(s). This icon functions as a toggle to activate or deactivate an object in a Specification or Domain listing. |
| Delete | Click Delete to remove the selected specification. A warning dialog opens with the option to cancel the action. |
| Previous / Next | Navigate through the pages. |
| Filters (active) Filters (inactive) | The active Filters icon indicates that filters are applied within the listing. By default, only specifications marked as Active display. Click the icon to clear or reset all filters, or clear individual filters by clicking the remove filter option next to the filtered column name. The inactive Filters icon indicates that no filters are applied within the listing. Click the icon to reapply the default Active filter. |
View Specification and Domain Version History
Users can view all versions and open previous versions of specifications and individual domains.
View Specification Versions
The specification version history shows the state of the specification, domains, variables, and codelists for each version.
Open the Specification Versions window using one of the following methods:
- Click the hyperlinked number in the Version column.
Click the hyperlinked number in the Approved Version column to open the list of domains of the approved version.
Click the '(v#)' in the breadcrumb of the Domains, Codelists, or Methods list to open the Specification Versions window. The link is available when more than one version exists. The breadcrumb displays the approved version number.
The Specification Versions window displays details for all versions and includes links to open each version.
- Click the hyperlinked number in the Version column to open that version.
- Click the Current Version (v#) button to return to the current version.
Click the Close button or the Close icon to close the window and return to the specifications listing.
View Domain Versions
Open the Domain Versions window using one of the following methods:
From the Domains listing, click the hyperlinked number in the Version column.
Click the Domains '(v#)' link in the breadcrumb of the Variable List.
The Domain Versions window displays details for all versions and includes links to open each verion.- Click the hyperlinked number in the Domain Version Number column to open that version.
- Click the Current Version (v#) button to return to the current version.
- Click the Close button or the Close icon to close the window and return to the specifications listing.