A set of compliance checks can be associated with each data standard. The data standards administrator can add new compliance checks and customize existing compliance checks for a data standard. Using these checks, you validate a clinical domain to determine whether it complies with the data standard. You perform validation by running a job that contains the CDISC-SDTM Compliance transformation or the CDISC-ADaM Compliance transformation.

The data standards administrator can customize validation for a data standard in the Manage Compliance Checks wizard. A compliance check can have an Active or Draft status. In the CDISC-SDTM Compliance transformation, where compliance checks are applied to clinical domains, non-administrator users can select and use only compliance checks that have an Active status. Only administrators can use compliance checks that have a Draft status. The Draft status enables administrators to set up and run compliance transformations to verify custom compliance checks. When an administrator is satisfied with the compliance check, the administrator changes the status to Active, and then the check is available to all clinical programmers.

Note: You must have the appropriate permissions to manage data standard compliance checks. For more information, see The Clinical Administrator Group.

Creating a Compliance Check

Overview: Creating a Compliance Check

Note: To create a compliance check, you must be an advanced user who understands how validation works using the SAS Clinical Standards Toolkit. SAS Clinical Standards Toolkit is invoked by the SAS code that is generated from a compliance transformation that uses validation. For more information about the SAS Clinical Standards Toolkit, see SAS Clinical Standards Toolkit: User's Guide.

The SAS Clinical Standards Toolkit provides a set of compliance checks for the data standards that support validation. SAS Clinical Data Integration imports these compliance checks when you import your data standards. You can create additional compliance checks and add them to the set.

The syntax for the following settings is determined by SAS Clinical Standards Toolkit:

Domain and domain column specifications
Code source
Terminology lookup and reporting

For task information, see Create or Edit a Compliance Check.

Domain Specification String and Column Specification String Values Requirements

A value for the domain specification string and column specification string must meet the following requirements:

Brackets must be matched.
Valid characters are letters (A-Z and a-z), digits (0 to 9), or the underscore (_).
The _ALL_ syntax specifier cannot be used.
The maximum length is 200 characters.

Check ID Value Requirements

A value for a check ID must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length is eight characters.
The value must be unique among all check IDs for any compliance check belonging to that data standard.

Check Type Value Requirements

A value for the check type must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length is 20 characters.

Severity Value Requirements

A value for the severity must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length is 40 characters.

Error Message Value Requirements

A value for the error message must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length is 500 characters.

Description Value Requirements

A value for the description must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters are valid. However, single and double quotation marks cannot be used together in the description. Use only single quotation marks or only double quotation marks.
The maximum length is 500 characters.

Code Source Value Requirements

A value for the code source must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length is 32 characters.

Code Value Requirements

A value for the code must meet the following requirements:

All characters are valid. However, single and double quotation marks cannot be used together in the description. Use only single quotation marks or only double quotation marks.
The maximum length is 2000 characters.

Lookup Type and Lookup Source Value Requirements

A value for the lookup type and lookup source must meet the following requirements:

The value must contain at least one non-whitespace character.
All characters, except single and double quotation marks, are valid.
The maximum length for a lookup type is 20 characters.
The maximum length for a lookup source is 32 characters.

View Compliance Checks

To view compliance checks, perform the following steps:

In the Clinical Administration tree, expand Data Standards.
Select a data standard, right-click, and then select Manage Compliance Checks.

The Manage Compliance Checks wizard appears.

Note: If the data standard does not support compliance checking, or it does not have a compliance check installed, then a message appears.
To view only the Check ID and Description columns, clear the Show details check box.

By default, the Available checks table displays details for each compliance check.

Note: You can sort the table by clicking on any column heading.
Click Close.

Create or Edit a Compliance Check

Start the Wizard

For conceptual information, see Creating a Compliance Check.

Note: If the Next and Finish buttons are dimmed on a page in the wizard, one or more of the values on the page are not valid, or a required value is missing. Review the requirements for each value, and make corrections as needed.

To start to create or edit a compliance check, perform the following steps:

View the compliance checks.

For more information, see View Compliance Checks.
To create a compliance check, right-click a compliance check, and then select Customize.

The Customize Compliance Check wizard appears.
To edit a compliance check, perform the following steps:
1. Right-click a compliance check, and then select Make Draft.
  
  To edit a compliance check, it must have a status of Draft.
2. Right-click the compliance check, and then select Edit.
  
  The Edit Compliance Check wizard appears.

Specify the Check Properties Values

To specify the check properties values, perform the following steps:

On the Check Properties page, edit the values by performing the following steps:
1. If you are creating a compliance check, enter a check ID.
  
  The value must meet the requirements; see Check ID Value Requirements.
2. Select or enter a check type.
  
  The value must meet the requirements; see Check Type Value Requirements.
3. Select or enter a severity.
  
  The value must meet the requirements; see Severity Value Requirements.
4. Enter a description.
  
  The value must meet the requirements; see Description Value Requirements.
5. In the Initial Status list, the default is always Draft.
  
  Note: After you test this check using the compliance transformation, you can set the status to Active.
Click Next.

The Domains page appears.

Specify the Domains

(Optional) To specify the domains, perform the following steps:

To enable the Domain Specification field for editing, and disable the Domains Referenced table, select the Direct Edit (Advanced) check box.
(Optional) In the Domains Referenced table, edit a row to adjust the values for the domain.
Note:
- When creating a compliance check, the Domains Referenced table might not be displayed. The table’s appearance depends on the type of compliance check that you have selected.
- When editing a compliance check, the Domains Referenced table appears only when the domain specification for the compliance check includes one or more domain IDs or domain specifiers.
In the Domain Specification field, enter the full domain specification string that is passed to SAS Clinical Standards Toolkit.

The value must meet the requirements; see Domain Specification String and Column Specification String Values Requirements.
Click Next.

The Domain Columns page appears.

Specify the Domain Columns

(Optional) To specify the domain columns, perform the following steps:

To enable the Column Specification field for editing, and to disable the Columns Referenced table, select the Direct Edit (Advanced) check box.
(Optional) In the Columns Referenced table, edit a row to adjust the values for the column.

Note: The Columns Referenced table appears only when the column specification includes one or more column IDs or column specifiers.
In the Column Specification field, enter the full column specification string that is passed to the SAS Clinical Standards Toolkit.

The value must meet the requirements; see Domain Specification String and Column Specification String Values Requirements.
Click Next.

The Check Code page appears.

Specify the Check Code Values

(Optional) To specify the check code values, perform the following steps:

To enable the Code Source drop-down list and the Code field for editing, select the Direct Edit (Advanced) check box.
(Required) In the Code Source list, select or enter a macro provided by the SAS Clinical Standards Toolkit.
Note:
- The Code Source list appears only when the column specification includes one or more column IDs or column specifiers.
- For more information about the macros, see the SAS Clinical Standards Toolkit: User's Guide.
In the Code field, enter the code to pass to the SAS Clinical Standards Toolkit.

SAS Clinical Data Integration does not validate the syntax in the code. However, it does validate that the value requirements are met. For more information, see Code Value Requirements.

Note: All code must be consistent with the selected code source. And, the code must be valid SAS code.
Click Next.

If a terminology lookup is included in the compliance check, the Controlled Terminology Lookup page appears. Otherwise, the Reporting Options page appears.

Specify the Controlled Terminology Lookup Values

(Optional) If a terminology lookup is included in the compliance check, specify the values by performing the following steps:

To enable the Lookup Type and Lookup Source drop-down lists for editing, select the Direct Edit (Advanced) check box.
(Required) In the Lookup Type list, select or enter the type of terminology lookup.

Note: SAS Clinical Data Integration does not validate whether the type exists.
(Required) In the Lookup Source list, you can select or enter the source of the terminology lookup.

Note: SAS Clinical Data Integration does not validate whether the source exists.
Click Next.

The Reporting Options page appears.

Specify the Reporting Options Values

(Optional) To specify the reporting options, perform the following steps:

To enable the Error Message field, select the Direct Edit (Advanced) check box.
To specify that all violations for the compliance check are reported every time the validation is run, select the Report All Violations check box.

If you clear this check box, only the first violation is reported.
In the Error Message field, enter the text to write to the data set when a violation is detected.

You can use substitution variables in this field.
Click Finish.

Change the Compliance Check Status

To change the status of a compliance check, perform the following steps:

View the compliance checks.

For more information, see View Compliance Checks.
Select one or more compliance checks, right-click, and then select either Make Draft or Make Active.

Delete a Compliance Check

To delete a compliance check, perform the following steps:

View the compliance checks.

For more information, see View Compliance Checks.
Select one or more compliance checks, right-click the compliance check, and then select Delete.

The compliance check is deleted from the table and from persistent storage for the data standard.

Managing Data Standard Compliance Checks

Overview: Managing Data Standard Compliance Checks

See Also