Methods are associated to 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,
Updates can only be made if the specification has the status of 'In Development'.
A blue badge at the right of Methods displays the number of methods associated with the specification. Items on the page in blue text are hyperlinks; the breadcrumbs contain the name and version of the specification, clicking the hyperlink returns to the specification. The selected Standard and Controlled Terminology are hyperlinks to the Standards module.
Columns include Open Issues, the method Name, Description, Type, Supporting Document, Page Number, Last Changed, and Last Changed By.
Methods Toolbar Actions Overview
From the listing, toolbar icons and buttons become active after selecting records by clicking in the checkbox(es) at the left, or you may also right-click on a record and select an action.
Actions include:
- Domains button: Click to go to Domains page.
- Codelists button: Click to go to the Codelists page.
- Add icon: Click to create a Codelist.
- Import Methods icon: Click to import an existing Method.
- Attachments icon: Click the name of an existing document, Upload Annotated CRF, Upload Supporting Doc, or Manage Documents.
- Properties icon: Click to open the properties of the selected Method.
- Edit icon: Click to edit the selected Method.
- Delete icon: Click to delete the selected Method.
- Issues icon: Click to create or view issues.
- Previous/Next Page icon: Click to see more rows, if applicable. Default page size is 25 rows.
- Filters icon: Identifies if filters are applied to the columns.
Import a Method
Methods can be imported from another 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 you wish to import by clicking in the checkboxes at the left, or select the checkbox in the header to select all.
- Click Import. The Methods listing displays with the imported methods.
Add a New Method
- Click the Add icon (the plus sign) 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 '< >' when entering into any of the fields. These symbols are not supported, and text entered within them will 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:
- Supporting Document: Click the drop-down to select a supporting document.
- Document Pages: Add document pages to reference in the supporting document.
- Click Save.
Edit Method Attributes
- Select the method you wish to edit by clicking the records, or clicking in the checkbox at the left of a method, or right-clicking on a row.
- From the listing, click the Edit icon in the toolbar or right-click and select Edit from the drop-down 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 '<>' when entering into any of the fields. These symbols are not supported, and text entered within them will 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 by clicking in the checkbox(es) at the left of the methods you wish to delete.
- Click the Delete icon in the toolbar or right-click and select Delete from the drop-down menu.
- A Delete Method(s)? warning window opens. Click OK to delete the selected methods; or select Cancel to cancel the action.
Use Breadcrumbs
The hyperlinked breadcrumbs display the specification name and version, and the status of the version.
Use Column Options
Columns can be sorted and filtered when clicking the column header. To sort, click on the header and select Ascending or Descending.
To filter, click on the header, select Filter. Filter options allow you to either include or exclude selections, include the blank values if appropriate, enter text to search and Filter Rows.
Click Clear to clear filters.