Contents
About
What's New in the SAS Clinical Standards Toolkit
Introduction to the SAS Clinical Standards Toolkit
What Is the SAS Clinical Standards Toolkit?
References
Framework
Overview
Global Standards Library
What Is a Standard?
Common Framework Metadata
Common Usage Scenarios for the Framework
Maintenance Usage Scenarios
Metadata File Descriptions
Overview
Standards
StandardSASReferences
Standardlookup
SASReferences
Properties
Messages
Results
Additional Metadata Files
Metadata Management
Overview
Transaction Log Data Set
Metadata Management Macros
Support Macros
Common Parameters
Copying a Data Set from One Library to Another Library
Adding Records to a Data Set
Updating a Column in a Data Set
Adding a Column to a Data Set
Modifying a Column Attribute in a Data Set
Deleting a Column in a Data Set
Deleting a Record in a Data Set
Deleting a Data Set
Registering a New Controlled Terminology Subset
Example Transaction Log Data Set
Supported Standards
SAS Representation of Standards
CDISC SDTM
CDISC ADaM 2.1
CDISC CRT-DDS 1.0
CDISC Define-XML 2.0
CDISC Analysis Results Metadata 1.0 for Define-XML 2.0
CDISC ODM
CDISC SEND 3.0
CDISC CDASH 1.1
CDISC Controlled Terminology
CDISC Dataset-XML 1.0
SASReferences File
Overview
Building a SASReferences File
How Is a SASReferences File Used?
Compliance Assessment Against a Reference Standard
Validation Framework Overview
Metadata Requirements
Cross-Standard Validation
Building a Validation Process
Running a Validation Process
Validation Checks by Standard
Special Topic: Validation Check Macros
Special Topic: How the SAS Clinical Standards Toolkit Interprets Validation Check Metadata
Special Topic: SAS Implementation of ISO 8601
Special Topic: Debugging a Validation Process
Special Topic: Validation Customization
Special Topic: Using Alternative Controlled Terminologies
Special Topic: Performance Considerations
Internal Validation
Overview
Supporting Macros
Validating a SASReferences Data Set
Sample Driver Programs
Validation Checks
XML-Based Standards
SAS Support of XML-Based Standards
Reading XML Files
Writing XML Files
Validation of XML-Based Standards
Special Topic: A Round-Trip Exercise Involving the CDISC SDTM and CDISC CRT-DDS Standards
Special Topic: Comparing the Metadata Defined in a Define-XML File with the Metadata from the SAS Version 5 XPORT Transport Files
Special Topic: Identifying Unsupported Elements and Attributes in a CDISC ODM File
Special Topic: Creating Study Source Metadata to Create a CDISC Define-XML 2.0 define.xml File
CDISC Dataset-XML
CDISC ADaM Data
Overview
SAS Representation of CDISC ADaM Metadata
ADaM Data Set Templates
Validation of ADaM Data Sets
Sample Reporting Methodology
Reporting
Sample Reports
Process Results Reporting
Validation Check Metadata Reporting
Global Macro Variables
Overview
Global Macro Variables and Their Associated Metadata
Additional Utility Macros
Overview
Generating PROC SQL Code to Create and Populate Data Sets
Generating PROC SQL Code to Create a Table from a SAS Data Set
Replacing Extended ASCII Characters in a SAS Data Set
Product
Release
SAS Clinical Standards Toolkit
Type
Usage and Reference
Copyright Date
September 2016
Last Updated
15Sep2016