Contents
About
Title Page
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
Supported Standards
SAS Representation of Standards
CDISC SDTM
CDISC ADaM 2.1
CDISC CRT-DDS 1.0
CDISC ODM 1.3.0
CDISC Terminology
SASReferences File
Overview
Building a SASReferences File
How Is a SASReferences File Used?
Validation
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
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: A Round Trip Exercise Involving the CDISC CRT-DDS Standard: Importing and Exporting the define.xml File
Special Topic: Identifying Unsupported Elements and Attributes in a CDISC ODM File
Working with 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
CST-Framework initialize.properties
CDISC ADaM 2.1 initialize.properties
CDISC ADaM 2.1 validation.properties
CDISC ADaM 2.1 report.properties
CDISC CRTDDS 1.0 initialize.properties
CDISC CRTDDS 1.0 validation.properties
CDISC ODM 1.3.0 initialize.properties
CDISC ODM 1.3.0 validation.properties
CDISC SDTM (3.1.1 and 3.1.2) initialize.properties
CDISC SDTM (3.1.1 and 3.1.2) validation.properties
General Purpose (not set in properties files)
ResultIDs and Associated Message Text
Macro Application Programming Interface
Module ADaM V2.1 (Run Time)
Module CRT-DDS V1.0 (Run Time)
Module Framework
Module SDTM V3.1.1 (Run Time)
Module SDTM V3.1.2 (Run Time)
Module ODM V1.3.0 (Run Time)
CDISC SDTM Validation Checks
Validation Checks (with SDTM V3.1.1)
Validation Checks (with SDTM V3.1.2)
Validation Checks
Validation Checks
Validation Checks
ODM 1.3.0 SAS Data Sets
Conventions Used in the Tables
ODM SAS Data Set
Study SAS Data Set
MeasurementUnits SAS Data Set
MUTranslatedText SAS Data Set
MetaDataVersion SAS Data Set
ProtocolEventRefs SAS Data Set
ProtocolTranslatedText SAS Data Set
StudyEventDefs SAS Data Set
StudyEventDefTranslatedText SAS Data Set
StudyEventFormRefs SAS Data Set
FormDefs SAS Data Set
FormDefTranslatedText SAS Data Set
FormDefItemGroupRefs SAS Data Set
FormDefArchLayouts SAS Data Set
ItemGroupDefs SAS Data Set
ItemGroupDefTranslatedText SAS Data Set
ItemGroupDefItemRefs SAS Data Set
ItemGroupAliases SAS Data Set
ItemDefs SAS Data Set
ItemDefTranslatedText SAS Data Set
ItemQuestionTranslatedText SAS Data Set
ItemQuestionExternal SAS Data Set
ItemMURefs SAS Data Set
ItemRangeChecks SAS Data Set
ItemRangeCheckValues SAS Data Set
RCErrorTranslatedText SAS Data Set
ItemRCFormalExpression SAS Data Set
ItemRole SAS Data Set
ItemAliasesSAS Data Set
CodeLists SAS Data Set
ExternalCodeLists SAS Data Set
EnumeratedItems SAS Data Set
CodeListItems SAS Data Set
CLItemDecodeTranslatedText SAS Data Set
ImputationMethods SAS Data Set
Presentation SAS Data Set
MethodDefs SAS Data Set
MethodDefTranslatedText SAS Data Set
MethodDefFormalExpression SAS Data Set
ConditionDefs SAS Data Set
ConditionDefTranslatedText SAS Data Set
ConditionDefFormalExpression SAS Data Set
ClinicalData SAS Data Set
SubjectDataSAS Data Set
StudyEventData SAS Data Set
FormData SAS Data Set
ItemGroupData SAS Data Set
ItemData SAS Data Set
ReferenceData SAS Data Set
AdminData SAS Data Set
User SAS Data Set
UserAddress SAS Data Set
UserAddressStreetName SAS Data Set
UserEmail SAS Data Set
UserFax SAS Data Set
UserPhone SAS Data Set
UserLocationRef SAS Data Set
Location SAS Data Set
LocationVersion SAS Data Set
SignatureDef SAS Data Set
AuditRecord SAS Data Set
Signature SAS Data Set
Annotation SAS Data Set
AnnotationFlag SAS Data Set
Association SAS Data Set
KeySet SAS Data Set
CRT-DDS 1.0 SAS Data Sets
Conventions Used in the Tables
DefineDocument SAS Data Set
Study SAS Data Set
MeasurementUnits SAS Data Set
MUTranslatedText SAS Data Set
MetaDataVersion SAS Data Set
AnnotatedCRFs SAS Data Set
SupplementalDocs SAS Data Set
MDVLeaf SAS Data Set
MDVLeafTitles SAS Data Set
ComputationMethods SAS Data Set
ValueLists SAS Data Set
ValueListItemRefs SAS Data Set
ProtocolEventRefs SAS Data Set
StudyEventDefs SAS Data Set
StudyEventFormRefs SAS Data Set
FormDefs SAS Data Set
FormDefItemGroupRefs SAS Data Set
FormDefArchLayouts SAS Data Set
ItemGroupDefs SAS Data Set
ItemGroupDefItemRefs SAS Data Set
ItemGroupAliases SAS Data Set
ItemGroupLeaf SAS Data Set
ItemGroupLeafTitles SAS Data Set
ItemDefs SAS Data Set
ItemQuestionTranslatedText SAS Data Set
ItemQuestionExternal SAS Data Set
ItemMURefs SAS Data Set
ItemRangeChecks SAS Data Set
ItemRangeCheckValues SAS Data Set
RCErrorTranslatedText SAS Data Set
ItemRole SAS Data Set
ItemAliases SAS Data Set
ItemValueListRefs SAS Data Set
CodeLists SAS Data Set
ExternalCodeLists SAS Data Set
CodeListItems SAS Data Set
CLItemDecodeTranslatedText SAS Data Set
ImputationMethods SAS Data Set
Presentation SAS Data Set
Product
Release
SAS Clinical Standards Toolkit
Type
Usage and Reference
Last Updated
01Nov2011