Permissions: Users will only see and have access to specifications for the studies to which they have permissions.
Specifications is a tool for authoring, viewing, and managing specifications for dataset mapping or exception listings for each study.
Available actions include creating and editing specification details, viewing version history details of historical specifications and domain versions, and create and manage issues. Workflow for specification status allows the users to take specifications through development to review with approval processes. Within the specification, the user defines domains, variables, and codelists used to map source data to the target format.
Access Specifications
The Specifications module is accessed from the Platform Menu.
By default, when you click on Specifications from the Platform Menu, the listing opens with a pre-programmed filter applied to display only active specifications. The blue badge indicates how many specifications are listed with applied filters. The active filter is identified by the solid Filters icon in the toolbar and the filtered column header is highlighted in orange. To see all specifications you can clear the filter.
Tip: Other columns can be filtered as well. For example, you may only want to see Mapping specifications.
Functionality within the module is consistent with other elluminate modules. In addition to toolbar actions, columns can be sorted, filtered, and fixed left or right. Filtered and sorted columns remain when a user moves from one panel to the next. When they return to the filtered / sorted panel, it remains filtered. Single specifications can be selected to edit, copy, approve, and delete; and multiple rows can be selected for export.
Listings Column Details
| HEADER | DETAILS |
|---|---|
| Open Issues | The number of open issues within the specification. The number is a hyperlink which opens a list of the open issues that can be actioned. |
| Name | The name of the specification that is an active hyperlink to the next level in the selected specification type. |
| Description | The description of the specification a user has entered. |
| Type | The type of specification, i.e. Mapping, Exception Listing. |
| Study | The study name. |
| Active | If checked the specification is in active development or in 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 with a hyperlink to version history. |
| Version Name | An alpha-numeric field for a custom version name that can be entered at any time. |
| 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 there is no approved version, the column is blank. |
| Last Approved Date | The modified date of the last approved version. If there is no approved version the column is blank. |
| Notes | Displays a user entered note about the specification. |
Use Toolbar Actions
Use the toolbar actions to manage specifications. For some actions, you must first select a row or rows. See the table below for details.
Toolbar Actions Table
(From left to right)
| ICON LABEL | ACTION |
|---|---|
| Domains | First select a specification by clicking a record or checking the box at the left of a record. Click Domains to navigate to the list of domains included in the specification. |
| Codelists | First select a specification by clicking a record or checking the box at the left of a record. Click Codelists to navigate to the list of codelists included in the specification. |
| Methods | First select a specification by clicking a record or checking the box at the left of a record. Click Methods to navigate to the list of methods included in the specification. |
| Change Status | First select a specification by clicking a record or checking the box at the left of a record. 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 | First select a specification by clicking a record or checking the box at the left of a record. Click to Upload Annotated CRF, Upload Supporting Doc, or Manage Documents. |
| Add | Click to create a new specification. |
| Edit | First select a specification by clicking a record or checking the box at the left of a record. Click to edit the selected specification. |
| Create New Version | First select an approved specification by clicking a record or checking the box at the left of a record. Click to create a new version of the selected specification. |
| Details | First select a specification by clicking a record or checking the box at the left of a record. Click to open the Details window. |
| Issues | Click to create or view issues. |
| Export |
First select a specification by clicking a record or checking the box at the left of a record. 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 | First select one or more specifications by clicking a record or checking the box at the left of the record(s). This is functions as a toggle to activate or deactivate an object in a Specification or Domain listing. |
| Delete | First select a specification by clicking a record or checking the box at the left of a record. Click to delete the specification. A warning box pops up giving you the option to cancel the action. |
| Previous / Next Page | Click to move to the previous or next page. By default, 20 rows display. |
| Filters (active) Filters (inactive) | Identifies there are filters applied within the listing. By default, only specifications checked as 'Active' display. Click to clear or reset filters. Identifies there are no filters applied within the listing. Click to reset pre-programmed filter to display only specifications checked 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 Approved Version column to open the list of domains of the approved version.
- Click on 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 specification.
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 on 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 specification.