Managing Data Standard Compliance Checks

Overview

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 with which he or she is working. Using these checks, you can validate a clinical domain to determine whether it complies with the data standard. Validation is performed by running a job that contains the CDISC-SDTM 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.

Problem

You want to manage the compliance checks for your data standard.

Solution

If you have administrator permission, then SAS Clinical Data Integration enables you to:
Note: You must have the appropriate permissions to view the Clinical Administration tree. For more information, see Adding Users to the Clinical Administrators Group.

Tasks

View Compliance Checks

To view compliance checks, complete the following steps:
  1. In the Clinical Administration tree, expand Data Standards. Right-click on the data standard that contains the compliance checks that you want to view. Select Manage Compliance Checks. The Manage Compliance Checks wizard opens.
    Note: If the data standard does not support compliance checking, or it does not have a compliance check installed, then a message is displayed.
  2. By default, the Available checks table displays details for each compliance check. To view only the Check ID and Description columns, clear the Show details check box.
    Note: You can sort the table by clicking on any column heading.

Create a Customized Compliance Check

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. For more information about compliance or validation, see the SAS Clinical Standards Toolkit: User's Guide.
The syntax for the following settings is determined by SAS Clinical Standards Toolkit:
  • Domain and domain column specifications
  • Code source
  • Terminology lookup and reporting
SAS Clinical Standards Toolkit is invoked by the SAS code that is generated from a compliance transformation using a check. For more information about the SAS Clinical Standards Toolkit, see SAS Clinical Standards Toolkit: User's Guide.
Note: You must have the appropriate permissions to view the Clinical Administration tree. For more information, see Adding Users to the Clinical Administrators Group.
To create a customized compliance check, complete the following steps:
  1. In the Manage Compliance Checks wizard, right-click on a compliance check. Select Customize. The Customize Compliance Check wizard opens. The Check Properties page appears. Most fields on this page default to the values that are used in the selected compliance check.
  2. On the Check Properties page, edit the values required for your customization.
    1. In the Check ID field, enter an ID that contains at least one non-whitespace character, but no more than 8 characters. All characters except single and double quotation marks are permitted. The ID must be unique among all check IDs for any compliance check belonging to that data standard.
    2. In the Check Type list, select or enter a check type that contains at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted.
    3. In the Severity list, select or enter a severity that contains at least one non-whitespace character, but no more than 40 characters. All characters except single and double quotation marks are permitted.
    4. In the Description field, enter a description that contains at least one non-whitespace character, but no more than 500 characters. All characters are permitted, but you cannot use single and double quotation marks together in the description. You can use only single quotation marks or only double quotation marks.
    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.
  3. Click Next. The Domains page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  4. Edit the values required for your customization.
    Note: To enable the Domain Specification field for editing, and disable the Domains Referenced table, select the Direct Edit (Advanced) check box.
    1. In the Domains Referenced table, you can edit a row to adjust the values for the domain.
      Note: The Domains Referenced table might not be displayed depending on the type of compliance check that you have selected.
    2. In the Domain Specification field, edit the full domain specification string that is passed to SAS Clinical Standards Toolkit.
      Note: If the domain specification string is not valid, then the Next and Finish buttons are dimmed. A domain specification string might not be valid in the following situations:
      • Brackets are mismatched.
      • Characters are not letters (A, B, C, . . . , Z), digits (0 to 9), or underscores.
      • Special characters, except for the underscore, are included.
      • The _ALL_ syntax specifier is included.
      • The length exceeds 200 characters.
  5. Click Next. The Domain Columns page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  6. Edit the values required for your customization.
    Note: To enable the Column Specification field for editing, and disable the Columns Referenced table, select the Direct Edit (Advanced) check box.
    1. In the Columns Referenced table, you can edit a row to adjust the values for the column.
      Note: The Columns Referenced table is displayed only when the column specification includes one or more column IDs or column specifiers.
    2. In the Column Specification field, edit the full column specification string that is passed to the SAS Clinical Standards Toolkit.
      Note: If the column specification string is not valid, then the Next and Finish buttons are dimmed. A column specification string might not be valid in the following situations:
      • Brackets are mismatched.
      • Characters are not letters (A, B, C, . . . , Z), digits (0 to 9), or underscores.
      • Special characters, except for the underscore, are included.
      • The _ALL_ syntax specifier is included.
      • The length exceeds 200 characters.
  7. Click Next. The Check Code page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  8. Edit the values required for your customization.
    Note: To enable the Code Source list for editing, and disable the Code field, select the Direct Edit (Advanced) check box.
    1. In the Code Source list, you can select a macro provided by the SAS Clinical Standards Toolkit. The value must contain at least one non-whitespace character, but no more than 32 characters. All characters except single and double quotation marks are permitted. This step is required.
      Note:
      • The Code Source list is displayed only when the column specification includes one or more column IDs or column specifiers.
      • For more information about selecting a macro, see the SAS Clinical Standards Toolkit: User's Guide.
    2. In the Code field, edit the code string that is passed to the SAS Clinical Standards Toolkit. SAS Clinical Data Integration does not validate the syntax in this code string. However, it does validate for the following criteria:
      • The code string contains no more than 2000 characters.
      • All characters are permitted, but you cannot use single and double quotation marks together in the description. You can use only single quotation marks or only double quotation marks.
      Note: Any code that you enter must be consistent with the selected code source. You must enter valid SAS code.
  9. Click Next. If the compliance check includes a terminology lookup, then the Controlled Terminology Lookup page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  10. If a terminology lookup is included in the compliance check, then edit the values required for your customization.
    Note: To enable the Lookup Type and Lookup Source lists for editing, select the Direct Edit (Advanced) check box.
    1. In the Lookup Type list, you can select or enter the type of terminology lookup. SAS Clinical Data Integration does not validate whether the type exists. The value must contain at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted. This step is required.
    2. In the Lookup Source list, you can select or enter the source of the terminology lookup. SAS Clinical Data Integration does not validate whether the source exists. The value must contain at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted. This step is required.
  11. Click Next. The Reporting Options page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  12. Edit the values required for your customization.
    Note: To enable the Error Message field for editing, select the Direct Edit (Advanced) check box.
    1. Select the Report All Violations check box to specify that all violations for the compliance check should be reported every time the validation is run. If you clear this check box, then only the first violation is reported.
    2. In the Error Message field, specify the text to write to the data set when a violation is detected. You can use substitution variables in this field. The text must contain at least one non-whitespace character, but no more than 500 characters. All characters except single and double quotation marks are permitted.
  13. Click Finish.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.

Edit an Existing Compliance Check

You only can edit compliance checks that have a Draft status. To set the status of a compliance check to Draft, right-click on the compliance check, and select Make Draft. To edit an existing compliance check, complete the following steps:
  1. In the Manage Compliance Checks wizard, right-click on a compliance check. Select Edit.
    The Edit Compliance Check wizard opens. The Check Properties page appears. Most fields on this page default to the values that are used in the selected compliance check.
  2. On the Check Properties page, edit the values required for your customization.
    1. In the Check Type list, select or enter a check type that contains at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted.
    2. In the Severity list, select or enter a severity that contains at least one non-whitespace character, but no more than 40 characters. All characters except single and double quotation marks are permitted.
    3. In the Description field, enter a description that contains at least one non-whitespace character, but no more than 500 characters. All characters are permitted, but you cannot use single and double quotation marks together in the description. You can use only single quotation marks or only double quotation marks.
    4. In the Initial Status list, the default is always Draft.
  3. Click Next. The Domains page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  4. Edit the values required for your customization.
    Note: To enable the Domain Specification field for editing, and disable the Domains Referenced table, select the Direct Edit (Advanced) check box.
    1. In the Domains Referenced table, you can edit a row to adjust the values for the domain.
      Note: The Domains Referenced table is displayed only when the domain specification for the compliance check that you are editing includes one or more domain IDs or domain specifiers.
    2. In the Domain Specification field, edit the full domain specification string that is passed to the SAS Clinical Standards Toolkit.
      Note: If the domain specification string is not valid, then the Next and Finish buttons are dimmed. A domain specification string might not be valid in the following situations:
      • Brackets are mismatched.
      • Characters are not alphanumeric.
      • The following specifiers are included: +, -,*, _ALL_, :.
      • The length exceeds 200 characters.
  5. Click Next. The Domain Columns page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  6. Edit the values required for your customization.
    Note: To enable the Column Specification field for editing, and disable the Columns Referenced table, select the Direct Edit (Advanced) check box.
    1. In the Columns Referenced table, you can edit a row to adjust the values for the column.
      Note: The Columns Referenced table is displayed only when the column specification for the compliance check that you are editing includes one or more column IDs or column specifiers.
    2. In the Column Specification field, edit the full column specification string that is passed to the SAS Clinical Standards Toolkit.
      Note: If the column specification string is not valid, then the Next and Finish buttons are dimmed. A column specification string might not be valid in the following situations:
      • Brackets are mismatched.
      • Characters are not alphanumeric.
      • The following specifiers are included: +, -,*, _ALL_, :.
      • The length exceeds 200 characters.
  7. Click Next. The Check Code page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  8. Edit the values required for your customization.
    Note: To enable the Code Source list and the Code field for editing, select the Direct Edit (Advanced) check box.
    1. In the Code Source list, you can select a macro provided by the SAS Clinical Standards Toolkit. The value must contain at least one non-whitespace character, but no more than 32 characters. All characters except single and double quotation marks are permitted. This step is required.
      Note: The Code Source list is displayed only when the column specification includes one or more column IDs or column specifiers.
    2. In the Code field, edit the code string that is passed to the SAS Clinical Standards Toolkit. SAS Clinical Data Integration does not validate the syntax in this code string. However, it does validate for the following criteria:
      • The code string contains no more than 2000 characters.
      • All characters are permitted, but you cannot use single and double quotation marks together in the description. You can use only single quotation marks or only double quotation marks.
      Note: Any code that you enter must be consistent with the selected code source. You must enter valid SAS code.
  9. Click Next. If the compliance check includes a terminology lookup, then the Controlled Terminology Lookup page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  10. If a terminology lookup is included, then edit the values required for your customization.
    Note: To enable the Lookup Type and Lookup Source lists for editing, select the Direct Edit (Advanced) check box.
    1. In the Lookup Type list, you can select or enter the type of terminology lookup. SAS Clinical Data Integration does not validate whether the type exists. The value must contain at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted. This step is required.
    2. In the Lookup Source list, you can select or enter the source of the terminology lookup. SAS Clinical Data Integration does not validate whether the source exists. The value must contain at least one non-whitespace character, but no more than 20 characters. All characters except single and double quotation marks are permitted. This step is required.
  11. Click Next. The Reporting Options page appears.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.
  12. Edit the values required for your customization.
    Note: To enable the Error Message field for editing, select the Direct Edit (Advanced) check box.
    1. Select the Report All Violations check box to specify that all violations for the compliance check should be reported every time the validation is run. If you clear this check box, then only the first violation is reported.
    2. In the Error Message field, specify the text to write to the data set when a violation is detected. You can use substitution variables in this field. The text must contain at least one non-whitespace character, but no more than 500 characters. All characters except single and double quotation marks are permitted.
  13. Click Finish.
    Note: If the Next and Finish buttons are dimmed, then one or more of the values on this page are not valid. Review the criteria for each value, and make any applicable corrections.

Change the Compliance Check Status

To change the status of a compliance check, complete the following steps:
  1. To change the status of a compliance check to Draft, right-click on the compliance check, and select Make Draft.
    Note:
    • A compliance check must have a Draft status for you to edit it.
    • You can select one or more compliance checks. To select a range of compliance checks, click on the first compliance check in the range. While holding down the SHIFT key, click on the last compliance check in the range. To select multiple compliance checks individually, click on the first compliance check. While holding down the CTRL key, click on other compliance checks.
  2. To change the status of a compliance check to Active, right-click on the compliance check, and select Make Active.
    Note: You can select one or more compliance checks.

Delete a Compliance Check

To delete a compliance check, right-click on the compliance check, and select Delete. A confirmation message is displayed. Click Yes to delete the compliance check from the table as well as from persistent storage for the data standard.
Note: You can select one or more compliance checks.
Copyright © SAS Institute Inc. All rights reserved.