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:
- They can be linked to a study in Mapper for domain and variable-level guidance, including field names, data types, labels, and codelists, allowing users to easily map domains and variables to the target format.
- It includes built-in workflow and version control, enabling users to advance specifications through development, review, and approval while tracking all changes.
- 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 pre-programmed filter applied to display only active specifications. The blue badge indicates the number of specifications listed with applied filters. The active filter is identified by the solid white Filters icon in the toolbar, and the filtered column header has a solid black Filter icon to the right of the header name. 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.
Functionality within Specifications is consistent with other elluminate products. In addition to toolbar actions, columns can be sorted, filtered, and fixed to the left or right. Filtered and sorted columns are retained when navigating between panels. When returning to a filtered or sorted panel, the previous settings remain in effect. Individual specifications can be selected for editing, copying, approval, deletion, or export.
Specification Listing Columns
| HEADER | 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 actioned. |
| Name | The name of the specification is an active hyperlink to the next level in the selected specification type. |
| Type | The type of specification, i.e., Mapping, 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 checked, 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 alpha-numeric field for a custom version name can be entered anytime. |
| Status | Displays the current status of the specification, i.e., In Development, Submitted for Review, Submitted for Approval, Approved. |
| Requires Domain Approval | This is checked if the specification type requires domain-level approval. When selected, each domain is independently approved. The specification can be moved 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 & Actions
Use toolbar actions to manage specifications. Select a row or multiple rows by clicking the record row or selecting the checkbox to the left of the 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 | After selecting the Specification, select the status from the drop-down. The current status is grayed out and the other statuses can be selected. 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 to create a new version of the selected specification. |
| Details | Select a specification, then click to open the Details window. |
| Issues | Click to create or view issues. |
| Export | Select the specification to export. Click 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 to remove the selected specification. A warning dialog appears, providing the option to cancel the action. |
| Previous / Next | Navigate through the pages. |
| Filters (active) Filters (inactive) | A solid white icon indicates that filters are applied within the listing. By default, only specifications marked as Active are displayed. Click the icon to clear or reset all filters, or clear individual filters by clicking the red circle next to the filtered column name. A grayed-out filter icon indicates that no filters are applied within the listing. Click to reapply the default filter, displaying only specifications marked as Active. |
View Specification and Domain Version History
Users can see all versions and load previous versions of specifications and individual domains.
View Specification Versions
Viewing the version history of a specification allows the user to see the state of the specification, domains, variables, and codelists.
There are 3 ways to open the Specification Versions window.
- 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 v# is a hyperlink if there is more than one version). Notice the breadcrumb displays the approved version number.
The Specifications Versions window provides the details for all versions with links to access them.
- Click the hyperlinked number in the Version column to open that version.
- Click the Current Version (v#) button in the bottom right corner to return to the current version.
Click the Close button or the x to close the window and return to the list of specifications.
View Domain Versions
There are 2 ways to open the Domain Versions window.
From a specification Domains listing, click the hyperlinked number in the Version column.
Click the Domains '(v#)' in the breadcrumb of the Variable List.
The Domain Versions window provides the details for all versions with links to access them.- Click the hyperlinked number in the Domain Version Number column to open that version.
- Click the Current Version (v#) button in the bottom right corner to return to the current version.
- Click the Close button or the x to close the window and return to the list of specifications.