Methods are associated with a variable and used for mapping transformations in SDTM and ADaM. Methods can be reused across studies and added or imported from another specification.
Functionality includes adding, editing, and deleting attributes of a method.
Note: Methods can only be updated if the specification has the status of 'In Development.'
When a new specification is created, a default list of mapping Methods is automatically generated and sorted alphabetically by Name. This list includes the most commonly used mapping types for SDTM and ADaM data transformations. This feature allows users to start authoring the new specification without needing to define the methods manually in advance.
A blue badge to the right of Methods displays the number of methods associated with the specification. Items on the page in blue text are hyperlinks or download links; the breadcrumbs contain the name and version of the specification, and clicking the hyperlink returns to the specification. The selected Standard and Controlled Terminology are hyperlinks to the Standards module.
Methods Listing Columns
| COLUMN | DETAILS |
|---|---|
| Open Issues | The number of open issues in the Specification Method. The blue number acts as a hyperlink to access the actionable issues. |
| Name | The name of the Method to be used in the Specification. |
| Description | Describes the purpose and functionality of the Method. |
| Type | The type of Method, such as Computational or Imputational. |
| Supporting Document | Upload the CRF and other supporting documents. Uploaded documents can be assigned to a method by editing the method. Document names are displayed as hyperlinks, allowing the files to be downloaded. |
| Page Number | The page numbers in the supporting document that refer to the method. |
| Last Changed | The date and time of the latest update |
| Last Changed By | The user who made the most recent update. |
Use Column Options
Clicking a column header allows sorting and filtering the column.
- To sort: Click the header and select Ascending or Descending.
- To filter: Click the header and select Filter. Then select the option to Include (default) or Exclude selections, select Blank Values if applicable, enter Text to search, and click Filter Rows.
- To clear filters: Click Clear to remove all applied filters.
Use Breadcrumbs
The hyperlinked breadcrumbs display the specification name and version, along with the status of the version. Click a breadcrumb to navigate to the corresponding page or return to a previous view.
Toolbar Icons and Actions
From the Methods listing, toolbar icons and buttons become active after selecting records by selecting the checkbox to the left of the row. Alternatively, right-click a record and select an action from the menu.
| BUTTONS / ICONS | ACTION |
|---|---|
| Domains | Navigate to the Domains page for the Specification. |
| Codelists | Navigate to the Codelists page for the Specification. |
| Add | Manually create a new Method. |
| Import Methods | Import Methods from other active Specifications. |
| Attachments | Click the name of an existing document, Upload Annotated CRF, Upload Supporting Doc, or Manage Documents. |
| Details | View the details and properties of the selected method. |
| Edit | Modify the selected method. |
| Delete | Delete the selected method. |
| Issues | Create or view the Specification Method Issues for the selected Method. |
| Previous / Next | Navigate through the pages. |
| Filters (active) Filters (inactive) | A solid white icon indicates filters are applied in the listing. Click the icon to clear filters and individual filters by clicking on the red circle next to the filtered column's name. A grayed-out filter icon indicates no filters are applied within the method's listing. |
Import a Method
Methods can be imported from another active specification. Users also have the ability to add custom methods and enter the details.
Import From Another Specification
- Click the Import Method icon. The Import Methods window opens.
- Select the methods to import by selecting the checkboxes to the left of each row or the header checkbox to select all.
- Click Import. The Methods listing displays the imported methods.
Add a New Method
- Click the Add icon in the toolbar. The Create Method window opens.
Enter appropriate details in each field. Name, Description, and Type are required fields.
Note: Do not use the symbols '< >' in any fields. These symbols are not supported, and text entered within them does not display in the Details panel.
- Name: Must be unique.
- Description: Description of the method.
- Type: Computation (typically used) or Imputation.
- Expression Code: Enter expression code.
- Expression Context: Enter expression context.
- Supporting Document: Click the drop-down and select a supporting document.
- Document Pages: Add document pages to reference in the supporting document.
- Click Save.
Edit Method Attributes
- Select the method to edit by clicking the record, selecting the checkbox to the left of the method, or right-clicking the row.
- From the listing, click the Edit icon in the toolbar or right-click and select Edit from the menu.
- The Method window opens and is populated with current values for the selected method.
Enter changes to the attributes.
Note: Do not use the symbols '<>' in any fields. These symbols are not supported, and text entered within them does not display in the Details panel.
- Click Save to save the changes and close the window, or click Cancel to close the window without saving changes.
Delete Methods
- Select the methods to delete by selecting the checkboxes to the left of the method names.
- Click the Delete icon in the toolbar, or right-click and select Delete from the menu.
- A Delete Method(s)? warning window opens. Click OK to delete the selected methods, or click Cancel to cancel the action.