1. Study Setup Guide
  2. Set up clinical data models
  3. Add columns to a table manually

Add columns to a table manually

You can add columns to a table as part of creating the table itself when you upload a file; see Create tables from a file.

Tip:

Be sure to add columns with the following SDTM IDs to support filtering in the Listings and Discrepancies windows: SUBJID, USUBJID, VISIT and VISITNUM. See Use SDTM identifiers to support important functionality.

  1. Click the Study Configuration icon Shows gear with pencil iconfrom the navigation bar. Then click the Clinical Data Models tab.

  2. Select the model and click Check Out.

    Caution: Do not make structural changes to tables in InForm models; see Modify an InForm input model for information on the changes that are and are not allowed.

  3. Select the table.

  4. In the Column tab, click the Icon is a plus sign.Add icon. The Create Clinical Data Model Column window opens. The system checks out the table if it is not already checked out.

    Note:

    There is a limit on the number of columns a table can have and still be displayed in the DMW Listings pages. See the note in Required syntax for metadata files for more information.

  5. Fill in the following fields:

    • Enter a Name and Description for the column; see Naming restrictions for restrictions.

    • Oracle Data Type: Select the appropriate data type: Varchar2, Number, or Date. All standard rules for Oracle data types apply.

      • DATE: For each Date value, Oracle stores the following information: century, year, month, date, hour, minute, and second. Although date and time information can be represented in both character and number datatypes, the Date datatype has special associated properties.

      • NUMBER: Stores zero, positive, and negative fixed and floating-point numbers. A Number column can contain a number with or without a decimal marker and/or a sign (-).

      • VARCHAR2: Specifies a variable-length character string. For each row, the system stores each value in the column as a variable-length field unless a value exceeds the column's maximum length, in which case the system returns an error.

    • Length: The requirements vary according to the data type:

      • DATE: No length required.

      • VARCHAR2: (Required) The default value is 50. The value must be between 1 and 4000.

      • NUMBER: (Required) The default value is 10. The maximum value is 38.

      If the data type is Number you can also enter a value for Precision, which is the total number of digits allowed to the right of the decimal point. For example, if Precision is set to 2 and a data value of 34.333 is entered in this column, the system stores the data value as 34.33. Oracle guarantees the portability of numbers with precision ranging from 1 to 38.

    • Map to Filter: If the column has the same function and data type as one of the SDTM column identifiers, it is good practice to select it from the list because the system uses this information in several ways; see Use SDTM identifiers to support important functionality.

    • Oracle Name: By default, the system populates this with the value you entered for the name, truncated at 30 characters.

    • SAS Name: By default, the system populates this with the value you entered for the name, truncated at 32 characters.

    • SAS Label: (Optional) By default, the system populates this with the value you entered for the name. It can be up to 256 characters.

    • SAS Format: By default, the system enters a dollar sign ($) followed by the value you entered in the Length field.

    • Default Value: (Optional). Enter a default data value.

    • Aliases for Automapping: Enter one or more aliases, or alternate names for the column. If you want more than one alias, enter a comma-separated list with no spaces; for example: dm,demo,demog,demography

    • Nullable: If selected, having a value in this column is not required. If not selected, all rows must have a value in this column.

    • Codelist (Optional): If the column should be populated with a limited set of values that are defined in a codelist, select the appropriate therapeutic area (or other category) and then the codelist. You can apply a codelist only to columns with a data type of varchar2.

      Note:

      If the table may need to be pivoted from a horizontal (short fat) structure to a vertical (tall skinny) structure—or the reverse—during a transformation, the pivot column must be associated with a codelist; see Pivot.

  6. Enter blinding attributes; available only if the table has a blinding type of Column; see Specify masking attributes for a column.

  7. Click OK.

Back to Set up clinical data models

Parent topic: Set up clinical data models