Creating an ADaM Data Set :: SAS(R) Clinical Data Integration 2.6: User's Guide

Overview: Creating an ADaM Data Set

You create an ADaM data set in a study or submission. At least one ADaM data standard must be associated with the study or submission. If more than one ADaM data standard is associated with the study or submission, you must choose the data standard to use.

The name of an ADaM data set must start with AD, and must be between three and eight characters in length.

Note: SAS Clinical Data Integration automatically provides AD in the name.

Data Set Properties

You can view and assign values to the properties that are associated with a data set and its variables.

Data Sources

The data source for an ADaM data set can be an SDTM domain, another ADaM data set, or any SAS data sets that are associated with the study or submission.

Variables to Include in the Data Set

You can select which variables to include in an ADaM data set. The variables are listed by category. The variables that are available to you are based on the type of ADaM data set that you choose to create.

Note: Certain variables are required and cannot be removed. The names of these variables are contained in [ ].

After you have selected the variables, you can specify this information about the variables:

the order of the variables
whether a variable is nullable (can have a null value)
the variables that are part of the key
the order of the key variables

Compliance Checks

There are dependencies between some variables and rules that govern the inclusion or exclusion of some variables. You can check that these dependencies and rules are satisfied before you create an ADaM data set.

Here are some examples of dependencies and rules:

If the TRTxxAN variable is included in a data set, the TRTxxA variable must be included.
An ADSL data set must contain at least one TRTxxP variable.
An ADAE data set must contain one or more of the ADSL variables TRTP, TRTA, TRTxxP, and TRTxxA.

Data Set Keys and Nullable Variables

You can choose to make a variable in an ADaM data set a key and to enable the variable to have a null value (nullable).

Here are the rules for data set keys:

There must be at least one key variable.
At least one key variable cannot be nullable.

Complete Set of Variables

Before you create an ADaM data set, you review the complete set of variables that you have chosen to include in the data set. For traceability, the source folder, source data set, source variable, and source derivation are shown for each variable.

If a variable is associated with a variable in a source data set, the values are supplied automatically. Otherwise, provide the values.

For each variable, a source derivation field is provided so that you can enter a description or SAS code that describes how the data is mapped from the source data into the variable.

Tip

Best practices for traceability require that you provide information about the origin of the data in a data set.

Create an ADaM Data Set

Specify Data Set Location and Type

To create an ADaM data set, perform the following steps:

In the Folder tree, select an ADaM-specific study or submission, and then select NewAnalysis Dataset.

The New Analysis Dataset wizard appears.
(Optional) Click Browse, and navigate to the location of an ADaM-specific study or submission.
Click Next.

If the study or submission contains multiple ADaM standards, the Analysis Standard Selection page appears. Otherwise, the Analysis Dataset Type page appears.
If the Analysis Standard Selection page appears, select a standard, and click Next.

The Analysis Dataset Type page appears.
Select an analysis data set type, and click Next.

For more information, see Overview: Types of ADaM Data Sets.

The General Information page appears.

Specify General Information and Data Set Properties

Enter a name and an identifier.

Note: There can be only one ADSL analysis data set in a study or submission. It must be named ADSL.
Click Next.

The Analysis Dataset Properties page appears.
(Optional) Specify the properties.

For more information, see Data Set Properties.
Click Next.

The Library Selection page appears.

Specify Library

(Optional) Select a library.
Click Next.

The Source Datasets page appears.

Specify Data Sources

(Optional) Select one or more source data sets.

For more information, see Data Sources.
Click Next.

If you selected one or more source data sets, the Select Variables from Source Datasets page appears. Otherwise, the Select analysis variables page appears.

Specify Variables and Check Compliance

On the Select Variables from Source Datasets page, perform the following steps:
1. Select a source data set and one or more source variables.
2. Click Add.
  
  The variable appears in the Added Variables table.
3. (Optional) To review variables that do not conform, select one or more variables from the Source Variables table or the Added Variable table, and click Non-Compliance.
  
  The Compliance Check Failures dialog box appears. Each non-compliant variable is listed with the reason why it does not comply.
4. To remove an added variable, select a variable in the Added Variable table, and click Remove.
On the Select analysis variables page, use the arrows to move variables between the Available Variables list and the Selected Variables list.

Note: Certain variables are required and cannot be removed. The names of these variables are contained in [ ].

Tip
You can select a category to move all of the variables in the category at one time.

For more information, see Variables to Include in the Data Set.
(Optional) To determine whether the selected variables comply with the rules concerning the dependencies between variables, perform the following steps:
1. Click Check Compliance.
  
  The Compliance Failures dialog box appears.
  
  For more information, see Compliance Checks.
2. Review the error messages, and click Cancel.
Click Next.

If you selected a variable with a parameter, one or more pages appear so that you can specify values for the parameters.

For more information, see Variables with xx, y, and zz Parameters and Wildcard Variables.

Specify Variable Parameters

Note: You must provide at least one value for each variable parameter. Without a value for each variable parameter, the variables cannot be generated.

If the Specify the Grouping Variables page appears, perform the following steps:
1. From the Grouping(y) Variables table, select one or more variables.
2. From the Values list, select one or more values, and click Assign.
3. Click Next.
If the Specify the Period Variables page appears, perform the following steps:
1. From the Period(xx) Variables table, select one or more variables.
2. From the Values list, select one or more values, and click Assign.
  
  Tip
  To limit the number of values, enter a value in the Maximum value field, and press Enter.
3. Click Next.
If the Specify the Record Selection Algorithm Variables page appears, perform the following steps:
1. From the Record Selection(zz) Variables table, select one or more variables.
2. From the Values list, select one or more values, and click Assign.
  
  Tip
  To limit the number of values, enter a value in the Maximum value field, and press Enter.
3. Click Next.
If the Wildcard Variables page appears, perform the following steps:
1. From the Wildcard Variable Templates table, select one or more variables.
2. Enter a value in the Name prefix field and the Description suffix field.
3. Click Add.
  
  The variable is added to the Generated Variables table.
  
  Note: You can add the same variable multiple times as long as the name differs.
4. To remove a variable from the Generated Variables table, select the variable, and click Remove.
5. Click Next.

Order Variables

(Optional) On the Order the variables page, select one or more variables, and click Move Up and Move Down below the table to order the variables.
(Optional) To order the data set keys, perform the following steps:
1. Click Order Keys.
  
  The Order Domain Keys dialog box appears.
2. Use Move Up and Move Down to order the keys.
Click Next.

The Complete Set of Variables page appears.

Review and Finish

Review the set of variables.

Tip
Best practices for traceability require that you provide information about the origin of the data in a data set.
To edit a value in the Source Folder, Source Dataset, or Source Variable columns, double-click a cell and enter a value.

Note: If a variable is associated with a variable in a source data set, the values are supplied automatically.
To edit the source derivation of a variable, perform the following steps:
1. Select a variable, and click Edit Source Derivation.
  
  The Edit Multiline Property Value for Source Derivation dialog box appears.
2. Enter the property value, and click OK.
Click Next.

The Summary page appears.
Review the summary, and click Finish.

Create an ADaM Data Set from a Define.xml File

To create an ADaM data set from a define.xml file, perform the following steps:

In the Folders tree, select a study or submission specific to ADaM, and then select NewAnalysis Dataset(s) From Define.

The New Analysis Dataset(s) From Define wizard appears.
Click Browse adjacent to Source, and navigate to the location of a define.xml file.
(Optional) Click Browse adjacent to Location, and then select a location in which to create the ADaM data set.
Click Next.

The Data Standard Selection page appears.
Select a data standard to associate with the analysis table, and then click Next.

The Analysis Table Selection page appears.
Select one or more analysis tables to import, and then click Next.

The Library Selection page appears.
(Optional) Select a library to associate with the analysis table, and then click Next.

The Summary page appears.
Review the summary, and then click Finish.

Creating an ADaM Data Set