SAS Clinical Standards Toolkit 1.4 Getting Started

SAS Clinical Standards Toolkit 1.4 Getting Started
SAS Clinical Standards
Toolkit 1.4
®
Getting Started
SAS® Documentation
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SAS ® Clinical Standards Toolkit 1.4: Getting Started
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Contents
About This Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
Recommended Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Chapter 1 • Introduction to the SAS Clinical Standards Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Key SAS Clinical Standards Toolkit Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The SAS Clinical Standards Toolkit File Roadmap . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Key SAS Clinical Standards Toolkit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Using the SAS Clinical Standards Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Chapter 2 • Sample Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Validating the CDISC ADaM Data Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Creating a define.xml File from CDISC SDTM 3.1.2 Source Data . . . . . . . . . . . . . . . . . 9
Importing and Validating a CDISC ODM XML File . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Chapter 3 • Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Global Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Process Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Creating and Modifying Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Validation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Macros . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
iv Contents
v
About This Book
Audience
The SAS Clinical Standards Toolkit and this book are designed for SAS programmers in
the clinical research industry. Programmers must have a good understanding of the SAS
macro language and must also be knowledgeable of evolving industry data standards,
such as the Clinical Data Interchange Standards Consortium (CDISC).
Requirements
This book does not attempt to provide instruction to install the SAS Clinical Standards
Toolkit. It is assumed that the SAS Clinical Standards Toolkit has been successfully
installed by a SAS Administrator and that the installation has been verified to have been
installed correctly and to be properly functioning.
vi About This Book
vii
Recommended Reading
Here is the recommended reading list:
•
SAS Clinical Standards Toolkit 1.4: User's Guide
This book provides more comprehensive information about the SAS Clinical
Standards Toolkit.
•
SAS Clinical Standards Toolkit 1.4: Installation Qualification
For a complete list of SAS publications, go to support.sas.com/bookstore. If you have
questions about which titles you need, please contact a SAS Publishing Sales
Representative:
SAS Publishing Sales
SAS Campus Drive
Cary, NC 27513-2414
Phone: 1-800-727-3228
Fax: 1-919-677-8166
E-mail: [email protected]
Web address: support.sas.com/bookstore
viii Recommended Reading
1
Chapter 1
Introduction to the SAS Clinical
Standards Toolkit
Key SAS Clinical Standards Toolkit Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
The SAS Clinical Standards Toolkit File Roadmap . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Key SAS Clinical Standards Toolkit Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Using the SAS Clinical Standards Toolkit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Key SAS Clinical Standards Toolkit Functionality
This book provides a brief introduction to the SAS Clinical Standards Toolkit. The SAS
Clinical Standards Toolkit serves two primary purposes:
•
Provide SAS implementations, based in SAS, of evolving clinical data standards.
•
Provide a framework that exploits these standards to meet common clinical research
analysis and submission requirements.
Through the Clinical Standards Toolkit 1.4 release, the SAS Clinical Standards Toolkit
supports only standards developed by the Clinical Data Interchange Standards
Consortium (CDISC). However, there is nothing in the product design that limits support
of other standards, and it is anticipated that both current users and future SAS Clinical
Standards Toolkit releases will support non-CDISC clinically-related standards.
The SAS Clinical Standards Toolkit is an open-source solution. Most of the code is
either Base SAS or SAS macro code; for XML-based standards some JAVA and XSLT
code is used. The SAS Clinical Standards Toolkit is a SAS solution for SAS users.
Given that study design, data collection, and analysis and submission requirements of
each research protocol are unique, and that the SAS Clinical Standards Toolkit provides
libraries of open-source SAS macros and code, user customization is expected and
encouraged.
The SAS Clinical Standards Toolkit File Roadmap
The SAS Clinical Standards Toolkit files can be aggregated into three primary groups:
•
the SAS Clinical Standards Toolkit Global Library
•
SAS program files (!sasroot)
2
Chapter 1
• Introduction to the SAS Clinical Standards Toolkit
•
Clinical study files
The primary function of the SAS Clinical Standards Toolkit Global Library is to provide
the metadata that defines each supported Clinical Standards Toolkit standard. This
location is specified during product installation and can be subsequently moved to
another location. By default, on Microsoft Windows, this location is set to
c:\cstGlobalLibrary.
Here are the top-level subfolders:
Figure 1.1 Global Library Top Folder Hierarchy
The metadata folder contains key metadata about all supported standards and can be
updated with each new product release. The metadata folder can also be updated each
time you elect to register a new standard or version of a standard. The schema-repository
and xsl-repository folders support XML-based standards (such as CDISC-ODM and
CDISC-CRTDDS). The standards folder contains a subfolder hierarchy for each
supported standard.
This folder hierarchy illustrates the types of metadata supporting the CDISC SDTM
3.1.2 standard:
Figure 1.2
Global Library Folder Hierarchy, CDISC SDTM 3.1.2
The control folder contains data sets that provide general metadata about the standard.
The macros folder contains standard-specific SAS macros that are included in the SAS
autocall path when working with that standard. The messages folder contains standardspecific messages used in reporting or process results. The metadata folder contains the
“gold-standard” definition of the standard as interpreted and implemented by who
registered the standard. The programs folder contains programs and property files
supporting general use of the standard. The validation folder and the control folder
contain validation check metadata for those standards supporting validation of standard
domains or data sets.
Installation of the SAS Clinical Standards Toolkit places files in the !sasroot tree for
both the common SAS Clinical Standards Toolkit framework files and for each
supported standard. The generic (cross-standard or standard-independent) framework
SAS macros are installed to !sasroot/cstframework/sasmacros (Microsoft
Windows). The SAS config file has been altered when the SAS Clinical Standards
Toolkit was installed to include this folder, by default, in the SASautos path, meaning
Key SAS Clinical Standards Toolkit Components
3
that the framework macros are available to you whenever and however you start SAS
referencing the default config file.
Within each standard subfolder hierarchy, there is a sample folder and a standards folder.
The standards folder is equivalent to the files included in the Global Library and
discussed previously. The sample folder hierarchy contains the set of files that represent
a sample implementation of the specific standard, sample study data sets, and sample
programs and results that illustrate the SAS Clinical Standards Toolkit functionality.
Here is the CDSIC ADaM 2.1 sample folder hierarchy:
Figure 1.3 !sasroot Folder Hierarchy for CDISC ADaM
This standard-specific folder hierarchy might be different for different standards. For
example, the CDISC ADaM analysis folder and subfolders are unique to ADaM.
The !sasroot location of these files merely provides a location for the sample SAS
implementation. Your study files might be located anywhere reachable by SAS and need
not conform to the folder naming convention illustrated here.
Key SAS Clinical Standards Toolkit Components
Framework and standard-specific SAS macros, as described above, provide the
foundation for the SAS Clinical Standards Toolkit functionality. Three other SAS
Clinical Standards Toolkit components are also noteworthy:
•
driver modules
•
properties
•
SASReferences data set
The SAS Clinical Standards Toolkit provides a set of driver modules (non-macro SAS
code) that illustrate all of the basic Toolkit functions using sample data supplied by SAS.
These drivers can serve as templates for the Toolkit processes you want to develop.
4
Chapter 1
• Introduction to the SAS Clinical Standards Toolkit
These drivers might be submitted as batch or interactive processes. They can be found in
the programs subfolder for each standard (for the relative location of this folder, see
Figure 1.3 on page 3). For a more complete description of what these drivers do, see
“Using the SAS Clinical Standards Toolkit” on page 5.
The SAS Clinical Standards Toolkit also provides a series of framework and standardspecific properties files (such as initialization, validation, and report properties files).
You can use these files to both define global macro variables and to set their default
values. These typically can be found in the same folders as the driver modules. Use of
these property files is optional but recommended, and you can add your own global
macro variables as needed.
Perhaps the single most important file used by the SAS Clinical Standards Toolkit is the
SASReferences data set. The SASReferences data set captures all the input and output
file library and file references associated with any given process. Here is a sample:
Figure 1.4
Sample SASReferences Data Set (CDISC SDTM 3.1.2 Validation Process)
Here are some general observations about the sample SASReferences data set shown
above:
•
The type and subtype values are used by the SAS Clinical Standards Toolkit code to
find the fileref or libref associated with a particular input or output file type.
•
The SASref can be any user-defined value.
•
An empty path tells the SAS Clinical Standards Toolkit to look for the default value
from the standard-specific metadata in the Global Library (usually a Global Library
location).
A complete discussion of the SASReferences data set is provided in Chapter 5,
“SASReferences File,” of the SAS Clinical Standards Toolkit 1.4: User's Guide. The
SAS Clinical Standards Toolkit defines a standard SASReferences data set for each
supported standard (found in <global library>/standards/<standard>/
control).
Using the SAS Clinical Standards Toolkit
5
Using the SAS Clinical Standards Toolkit
The SAS Clinical Standards Toolkit Global Library contains the SAS metadata
definition of all supported standards. This metadata definition, defined primarily as the
reference_tables and reference_columns data sets, can be used as defined. The metadata
definition also can be modified or used as a template to build your own SAS
representation of the CDISC standards supplied by SAS or your own customized
standard.
Sample driver modules are provided with each supported standard. These modules can
be copied and modified to reflect your own data and metadata sources and the target
location for any SAS process output. These drivers all follow the same general process
workflow:
•
Set any process global macro variable values.
•
Define a root path for input and output files (unnecessary if you do not use relative
paths and you specify explicit paths).
•
Create or reference a SASReferences data set that defines all input/output files.
•
Call the cstutil_processsetup() macro that confirms a valid SASReferences structure,
allocates any SAS librefs and filerefs, set the process-specific macro autocall and
format search paths.
•
Call the primary macro of interest (such as validation or define creation macro).
•
(Optional) Perform any session cleanup.
For a more complete description of what a driver module does, see “Running a
Validation Process” in Chapter 6, “Validation,” of the SAS Clinical Standards Toolkit
1.4: User's Guide.
6
Chapter 1
• Introduction to the SAS Clinical Standards Toolkit
7
Chapter 2
Sample Scenarios
Validating the CDISC ADaM Data Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Assumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Location of ADaM-Specific Driver Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Step 1: Derive Metadata About Your Source Data . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Step 2: Build Your Own Driver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Step 3: Submit the Modified Driver Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Creating a define.xml File from CDISC SDTM 3.1.2 Source Data . . . . . . . . . . . . . . 9
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Assumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Location of the CRTDDS-Specific Driver Modules . . . . . . . . . . . . . . . . . . . . . . . . . 9
Step 1: Extract Available SDTM Metadata into CRTDDS Metadata Files . . . . . . . . 9
Step 2: (Optional) Populate the Remaining CRTDDS Data Sets . . . . . . . . . . . . . . . . 9
Step 3: Create the define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Step 4: Validate the Generated define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Importing and Validating a CDISC ODM XML File . . . . . . . . . . . . . . . . . . . . . . . . 11
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Assumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Location of the ODM-Specific Driver Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Step 1: Validate the ODM XML File against the ODM 1.3.0 XML Schema . . . . . 11
Step 2: Import the ODM XML File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Step 3: Validate the SAS Representation of the ODM XML File . . . . . . . . . . . . . . 13
Validating the CDISC ADaM Data Sets
Assumption
You have a library of CDISC ADaM SAS data sets (for purposes of this example,
derived from a library of CDISC SDTM 3.1.2 domains). Derivation of ADaM analysis
files from SDTM domains is not a supported function in the SAS Clinical Standards
Toolkit. Products such as SAS Clinical Data Integration can be used to create such
mapping processes and transformation processes.
Location of ADaM-Specific Driver Modules
The ADaM-specific driver modules are located here:
8
Chapter 2
•
Sample Scenarios
!sasroot/../../SASClinicalStandardsToolkitADaM21/1.4/sample/
cdisc-adam-2.1/sascstdemodata/programs
Step 1: Derive Metadata About Your Source Data
Before you can validate your ADaM data sets, you must derive a set of metadata that
describes your library of analysis data sets. In the SAS Clinical Standards Toolkit, the
metadata that describes your study data sets and columns is generally referred to as
“source metadata.” To help derive this metadata, the SAS Clinical Standards Toolkit
provides a sample driver module (create_sourcemetadata.sas) that calls the SAS macro
adamutil_createsrcmetafromsaslib.sas found in the <global library>/
standards/cdisc-adam-2.1-1.4/macros folder. This macro uses Base SAS
metadata (proc contents output) and reference metadata (supplied by SAS) describing
the CDISC ADaM standard to initialize the source metadata. You might find it necessary
to augment or modify this approach based on other metadata you have available or other
processes that you adopt.
Step 2: Build Your Own Driver Module
The sample driver that can be run to demonstrate the ADaM validation process is
validate_data.sas. Use this driver as a sample to build your own driver module,
specifying the locations of source data and metadata. Take note of the SASReferences
data set created in the validate_data driver. It references both SDTM and ADaM data
and metadata as well as ADaM controlled terminology. Reference to the SDTM
metadata supports comparison of ADaM column metadata with SDTM column metadata
for those columns derived directly from SDTM. (See “Assumption” on page 7.)
Step 3: Submit the Modified Driver Module
The SAS Clinical Standards Toolkit validation processes generally create two types of
output data sets: validation results and validation metrics. The names and locations of
these SAS data sets depend on your SASReferences specifications for results
management.
Here is a display that illustrates a sample Results data set produced by the validation
process:
Figure 2.1
Partial Sample Results Data Set (CDISC ADaM 2.1 Validation Process)
Creating a define.xml File from CDISC SDTM 3.1.2 Source Data
9
The validation results shown above are representative of the range of validation results
one might see, from no reported errors (such as ADAM0001) to multiple errors detected
(such as ADAM0053) to an inability to run a specific check because of a lack of data or
metadata (such as ADAM0102). The validation metrics output data set attempts to
summarize the validation results and provide a denominator for each check.
For a more thorough discussion of how validation is performed, see Chapter 6,
“Validation,” of the SAS Clinical Standards Toolkit 1.4: User's Guide.
Creating a define.xml File from CDISC SDTM 3.1.2
Source Data
Overview
The SAS Clinical Standards Toolkit supports the currently published CDISC CRTDDS
1.0 (define.xml) submission standard, which supports representation of the CDISC
SDTM 3.1.1/3.1.2 tabulation data sets in metadata form. (Future releases are expected to
support updates to the CRTDDS standard that support representation of CDISC ADaM
analysis data sets.)
Assumption
You have a library of CDISC SDTM SAS data sets (which are not read by this process)
from which a set of metadata (in the form of source_study, source_tables, and
source_columns data sets) has been created. This metadata must contain the expected,
correctly typed columns created for the sample study supplied by SAS.
Location of the CRTDDS-Specific Driver Modules
!sasroot/../../SASClinicalStandardsToolkitCRTDDS10/1.4/sample/
cdisc-crtdds-1.0/programs
Step 1: Extract Available SDTM Metadata into CRTDDS Metadata
Files
The initial task is to extract available SDTM metadata into CRTDDS metadata files. The
SAS representation of CRTDDS involves 39 data sets, but only 12 of these derive
directly from SDTM. The sample driver create_crtdds_from_sdtm.sas, modified to point
to your specific SDTM study, should be submitted to extract the SDTM metadata. This
process builds all 39 data sets but populates only 12 (depending on your study).
Note: The key input (source) files are the SDTM metadata files (source_study,
source_tables, and source_columns), not the SDTM domain data sets.
Step 2: (Optional) Populate the Remaining CRTDDS Data Sets
None of the remaining 39 data sets must be populated to create a viable define.xml file
using the SAS Clinical Standards Toolkit. However, Value Level metadata and
annotated CRF page references are needed to make the define.xml useful for review and
10
Chapter 2
•
Sample Scenarios
analysis. The next step is to populate the remaining CRTDDS data sets using your own
metadata sources and methods.
For more discussion of this step, see FAQ “How Do I Add Supplemental Data (Not
Directly Derivable from Other Standards Such as CDISC SDTM) Used to Create a
define.xml File?” on page 20. Also, for a discussion of the data sets most critical for
successful derivation of the define.xml file, see “Special Topic: A Round Trip Exercise
Involving the CDISC CRT-DDS Standard: Importing and Exporting the define.xml File”
in Chapter 7 of the SAS Clinical Standards Toolkit 1.4: User's Guide.
Note: If you do not have additional metadata, you can skip this step.
Step 3: Create the define.xml File
At this point, all available content for the define.xml file has been captured in the SAS
representation (39 data sets) of the CDISC CRTDDS standard. The SAS Clinical
Standards Toolkit provides a sample driver module, create_crtdds_define.sas. This
module builds and validates the define.xml file. Now, submit the
create_crtdds_define.sas driver.
Within this driver, the call to the primary task macro (located in
<global library>/standards/cdisc-crtdds-1.0-1.4/macros):
%crtdds_write(_cstCreateDisplayStyleSheet=1);
requests that the default style sheet supplied by SAS (source: CDISC) be copied to the
folder location containing the generated define.xml file.
Here is a portion of the define.xml file, as rendered by this default style sheet.
Hyperlinks among tables, columns, codelists, and other file elements are provided.
Figure 2.2
Partial Sample define.xml File (as Rendered by the Default Style Sheet)
Step 4: Validate the Generated define.xml File
The final step is to validate the generated define.xml file. As discussed in Chapter 7,
“XML-Based Standards”, of the SAS Clinical Standards Toolkit 1.4: User's Guide, the
SAS Clinical Standards Toolkit offers two complementary validation methodologies.
•
The first methodology relies on the definition of a master set of validation checks as
described in the previous example. This method uses SAS files and SAS code to
validate the SAS representation of the standard. Example checks include the
assessment of foreign key relationships across data sets and value conformance to a
set of expected values.
•
The second methodology involves verification that the XML file is valid structurally
and syntactically according to the XML schema.
The final task in the sample create_crtdds_define.sas driver is to call the
crtdds_xmlvalidate() macro to perform the schema validation.
Importing and Validating a CDISC ODM XML File
11
Here is part of the Results data set:
Figure 2.3 Partial Sample Results Data Set (CDISC CRTDDS 1.0 Create Process)
This Results data set provides process information and the location of the generated
define.xml file. The Results data set confirms that no problems were found with the file
following validation of the file. Note that the SAS validation of file content was not run
in this example.
Importing and Validating a CDISC ODM XML File
Overview
The SAS Clinical Standards Toolkit supports the currently published CDISC ODM 1.3.0
standard, which facilitates the archival and interchange of the metadata and data for
clinical research. The SAS Clinical Standards Toolkit can import an ODM XML file into
a SAS data set representation of the ODM 1.3.0 standard.
Assumption
You have an ODM XML file (which is not created by this process) from which a SAS
representation (in the form of 66 SAS data sets) has to be created.
Location of the ODM-Specific Driver Modules
!sasroot/../../SASClinicalStandardsToolkitODM130/1.4/sample/
cdisc-odm-1.3.0/programs
Step 1: Validate the ODM XML File against the ODM 1.3.0 XML
Schema
The initial task is to validate the ODM XML file against the ODM 1.3.0 XML schema.
This involves verification that the ODM XML file is valid structurally and syntactically
according to the XML schema. The sample driver create_sasodm_fromxml.sas, modified
to point to your specific ODM XML file, contains a call to the odm_xmlvalidate macro
to perform this schema validation task.
12
Chapter 2
•
Sample Scenarios
Here is part of the Results data set:
Figure 2.4 Partial Sample Results Data Set (CDISC ODM 1.3.0 Schema Validation Process)
This Results data set provides process information, the location of the ODM XML file,
and confirms that the ODM XML file validated successfully.
Here is a Results data set that shows schema validation issues with an ODM XML file:
Figure 2.5
Partial Sample Results Data Set (CDISC ODM 1.3.0 Schema Validation Process) – Invalid ODM XML File
Running the odm_xmlvalidate macro is not required to be able to import an ODM XML
file. However, importing an invalid ODM XML file can result in an incomplete import,
because the odm_read macro ignores elements and attributes in the ODM XML file that
are not defined by the XML schema.
Step 2: Import the ODM XML File
The next step is to import the ODM XML file by calling the odm_read macro, which
results in 66 SAS data sets describing the CDISC ODM 1.3.0 data model. The odm_read
macro is called by the sample driver create_sasodm_fromxml.sas.
Here is the Results data set. It provides process information and the location of the
imported ODM XML file. The Results data set also confirms that no problems were
Importing and Validating a CDISC ODM XML File
13
found with the import. And, the Results data set shows that format catalogs and data sets
have been created.
Figure 2.6 Partial Sample Results Data Set (CDISC ODM 1.3.0 Read Process)
Step 3: Validate the SAS Representation of the ODM XML File
The final step in importing an ODM XML file is to validate the SAS representation of
the ODM XML standard. In step 1, we had already validated the ODM XML file against
the XML schema. The validation of the SAS representation of the ODM XML standard
goes further than XML schema validation.
An example of a check that is part of the validation of SAS representation is the
assessment of foreign key relationships across data sets. The SAS Clinical Standards
Toolkit provides a sample driver program, validate_odm_data.sas, which validates the
SAS representation of an ODM XML file.
Submit the modified driver module. The SAS Clinical Standards Toolkit validation
processes generally create two output files: validation results and validation metrics. The
names and locations of these SAS data sets depend on your SASReferences
specifications for results management.
Here is an example of a Results data set produced by the validation process:
Figure 2.7 Partial Sample Results Data Set (CDISC ODM 1.3.0 Validation Process)
In this example there are several issues in the foreign key relations across data sets.
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Sample Scenarios
15
Chapter 3
Frequently Asked Questions
Global Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Does It Matter Where the Global Library is Located? . . . . . . . . . . . . . . . . . . . . . . . 16
How Do I Change the Location of the Global Library? . . . . . . . . . . . . . . . . . . . . . . 16
Process Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
How Do I See Process Results? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
How Do I Customize a Registered Standard? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
How Do I Register a New Standard (or a New Version for an
Existing Standard)? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Does SAS Offer Updates for Previously Released Standards? . . . . . . . . . . . . . . . . 17
Creating and Modifying Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Should I Modify SAS Clinical Standards Toolkit Files
Supplied by SAS If I Want to Test Changes or Make
Permanent Changes to Any of Those Files? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
How Do I Modify a Sample Driver Program to Point to My Own Study Data? . . . 18
How Do I Create the Required Study Metadata? . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Can I Modify the Check Metadata Columns tableScope and
columnScope to Match My Study? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Can I Add My Own New Validation Checks for SDTM or ADaM? . . . . . . . . . . . . 19
How Do I Use My Own Controlled Terminology? . . . . . . . . . . . . . . . . . . . . . . . . . 19
How Do I Point to My Company’s Version of MedDRA? . . . . . . . . . . . . . . . . . . . 19
How Do I Use My Own Style Sheet with a SAS Clinical
Standards Toolkit-Generated define.xml File? . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Can I Associate a Style Sheet with an ODM XML File
Generated by the SAS Clinical Standards Toolkit? . . . . . . . . . . . . . . . . . . . . . . . 20
How Do I Add Supplemental Data (Not Directly Derivable
from Other Standards Such as CDISC SDTM) Used to
Create a define.xml File? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
How Do I Create the Data Sets That Are Used to Create an ODM XML File? . . . . 21
How Do I Modify the autocall Path to Point to My Own Macros? . . . . . . . . . . . . . 21
Do I Have to Create and Use a SASReferences Data Set for
Any SAS Clinical Standards Toolkit Process That I Run? . . . . . . . . . . . . . . . . . . 21
Do I Need to Use Properties Files to Define My Own Global Macro Variables? . . 22
Validation Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Do I Have to Run All of the SAS Validation Checks for SDTM? . . . . . . . . . . . . . . 22
Can I Run a Validation Process in the SAS Clinical Standards
Toolkit on Multiple Studies Simultaneously? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
If I Disagree with or Choose to Modify the Codelogic of a
Specific Validation Check, What Needs to Be Done? . . . . . . . . . . . . . . . . . . . . . 23
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Frequently Asked Questions
Macros . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Is There Any Debugging Help for SAS Macro Errors? . . . . . . . . . . . . . . . . . . . . . . 23
Where Do the Framework and Standard-Specific Macros Reside? . . . . . . . . . . . . . 23
Miscellaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
How Do I Report Problems, Ask Questions, or Get More
Information about How to Use the SAS Clinical Standards Toolkit? . . . . . . . . . . 24
Can the SAS Clinical Standards Toolkit 1.4 Be Used with
Any Release of SAS Besides SAS 9.3? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
How Is Availability of a New SAS Clinical Standards Toolkit
Release Publicized? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Does a New Version of the SAS Clinical Standards Toolkit
Automatically Overwrite Files Installed with a Previous Version? . . . . . . . . . . . 24
Global Library
Does It Matter Where the Global Library is Located?
No. On Microsoft Windows systems, the default location for the Global Library is
c:/cstGlobalLibrary. This location is assumed (and referenced as <global
library>) throughout this document. <global library> can point to any location that is
accessible by SAS.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: For a summary of the
cstGlobalLibrary, see “Global Standards Library” in Chapter 2, “Framework.”
How Do I Change the Location of the Global Library?
The value of the variable cstGlobalLibrary is set during installation of the SAS Clinical
Standards Toolkit. If you want to change the location after installation, you must modify
the framework autocall utility macro cstutil_setcstgroot to point to the new location that
you have chosen.
Note: The SAS Clinical Standards Toolkit recognizes and uses only one Global Library
at a time.
Process Results
How Do I See Process Results?
The default location for the results of a SAS Clinical Standards Toolkit process is set by
the _cstResultsDS property in the framework initialize.properties file. By default, this is
set to work._cstresults. Process results can be persisted, if the SASReferences data set
has a type=results record.
Note: All SAS Clinical Standards Toolkit process Results data sets have the same
structure and all columns have the same meaning.
Standards
17
Standards
How Do I Customize a Registered Standard?
The definition of each standard (and version of each standard) is done in the Global
Library. A best practice recommendation is that you do not (permanently) modify the
Global Library files, but instead modify copies of the files.
The files and metadata that constitute a standard vary from standard to standard. Use the
files that define each standard, located in
<global library>/standards/<standard>, as templates, adding your
customizations. You can rename or otherwise introduce your own subfolders and files
that constitute each standard. If you want to create your own version of an existing
registered standard, review the information in the next question.
How Do I Register a New Standard (or a New Version for an Existing
Standard)?
Use the SAS Clinical Standards Toolkit framework utility macro cst_registerstandard.sas
to register a new standard. A new subfolder hierarchy is added to the
<global library>/standards/ location, and the
<global library>/metadata/standards.sas7bdat data set is updated with
metadata about the new standard. This metadata is provided in the form of two data sets,
standards, and StandardSASReferences. These data sets are passed to the SAS Clinical
Standards Toolkit as parameters in the call to the cst_registerstandard macro.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Maintenance Usage
Scenarios” in Chapter 2, “Framework.”
Does SAS Offer Updates for Previously Released Standards?
New production releases of the SAS Clinical Standards Toolkit routinely provide
updates to previously released standards. For information about how these updates are
provided, see “Does a New Version of the SAS Clinical Standards Toolkit
Automatically Overwrite Files Installed with a Previous Version?” on page 24.
SAS also makes available a SAS support knowledge base focus area (http://
support.sas.com/rnd/base/cdisc/cst/index.html) to communicate
product information, references, and updates. Preproduction files are also available for
download.
The SAS Clinical Standards Toolkit development team also supports the early adopter
phase and works with development partners on future product releases.
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Frequently Asked Questions
Creating and Modifying Files
Should I Modify SAS Clinical Standards Toolkit Files Supplied by
SAS If I Want to Test Changes or Make Permanent Changes to Any
of Those Files?
A best practice recommendation is that you do not (permanently) modify framework
autocall macros or Global Library files, but instead modify copies of the files. This
allows seamless updates to those files supplied by SAS without concern about
overwriting or losing your changes.
Note: The SAS Clinical Standards Toolkit provides an internal backup of standardspecific Global Library files supplied by SAS in the !sasroot standard-specific
sample subfolders.
How Do I Modify a Sample Driver Program to Point to My Own Study
Data?
Each sample driver module sets a &studyRootPath macro variable to point to the root
path of the sample study SAS supplies for each standard. This macro enables you to
point to your own study root path by resetting the value of this macro variable. You
might instead prefer to use explicit paths in your SASReferences data set and not use
&studyRootPath at all.
The sample drivers assume a study folder hierarchy like that of the sample study, but this
hierarchy is not required. If you have another organization for your study, you might
need to make other changes to the paths specified in your driver module.
How Do I Create the Required Study Metadata?
Each supported standard might define study metadata differently. The SAS
representation of the 32 standard CDISC SDTM 3.1.2 domains differs from the SAS
representation of the three types of tables supported in CDISC ADaM 2.1.
Most users have metadata about their studies in some form and file format other than
that used by the SAS Clinical Standards Toolkit. You have to convert or map some of
that metadata into the source_study, source_tables, and source_columns format specified
in the sample study metadata folder (such as !sasroot/../../
SASClinicalStandardsToolkitADaM21/1.4/sample/cdisc-adam-2.1/
sascstdemodata/metadata). Some standards provide sample code that supports
this task. For CDISC ADaM, look at the create_sourcemetadata.sas sample driver
module as an example.
Note: The structure of the source metadata corresponds to the reference metadata for
each standard as defined in the Global Library (such as <global library>/
standards/cdisc-adam-2.1-1.4/metadata reference_tables and
reference_columns data sets).
Creating and Modifying Files
19
Can I Modify the Check Metadata Columns tableScope and
columnScope to Match My Study?
Yes. The initial values are based on the sample data associated with each standard. Your
study data almost certainly differs. For CDISC SDTM and CDISC ADaM, your domains
and analysis data sets reflect your study protocol. Some checks might not apply to some
of your domains because your implementation of that domain might deviate from other
domains from the same class (such as Findings).
Be aware that tableScope and columnScope wildcarding is a convenience, and you can
instead explicitly reference a specific table or column in any check invocation.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Validation Check
Metadata: Validation Master” in Chapter 6, “Validation.”
Can I Add My Own New Validation Checks for SDTM or ADaM?
Yes. You can add checks to any SAS Clinical Standards Toolkit standard that supports
validation. Each check is defined as a set of metadata (in the validation_master data set
found in the <global library>/standards/<standard>/validation/
control folder) and a message to be used when an error is detected (in the messages
data set found in the <global library>/standards/<standard>/messages
folder).
For each new check, you must create the check metadata to conform to the
validation_master template and an associated message to conform to the messages data
set metadata structure.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: For more information
about check metadata and the available SAS Clinical Standards Toolkit validation check
macros, see Chapter 6, “Validation.”
How Do I Use My Own Controlled Terminology?
The SAS Clinical Standards Toolkit permits the use of any set of controlled terminology
or any coding dictionaries. Generally, controlled terminology is defined to the SAS
Clinical Standards Toolkit as SAS format catalogs; coding dictionaries as SAS data sets.
Either format is valid.
The SASReferences data set is used to document these format catalogs and coding
dictionaries, and to facilitate run-time references to these reference input sources. In the
SAS Clinical Standards Toolkit sample drivers, a SASReferences type=fmtsearch record
points to each SAS format catalog (and allows specification of a reference order for likenamed formats), and a type=referencecterm record points to each specific coding
dictionary to be referenced. The format search path is set with the call to the
cstutil_processsetup macro.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: For more information
about using controlled terminology in validation processes, see “Special Topic: Using
Alternative Controlled Terminologies” in Chapter 6, “Validation.”
How Do I Point to My Company’s Version of MedDRA?
The sample SDTM SASReferences data set offers an example of referencing the
MedDRA dictionary. The type=referencecterm record points to a folder (which can be
anywhere) that can contain a MedDRA data set (using any name).
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Frequently Asked Questions
The SDTM validation check (SDTM0451) supplied by SAS that compares AEDECOD
to MedDRA preferred terms expects that the MedDRA data set contains the column
PT_NAME. If your data set uses other column names, see “If I Disagree with or Choose
to Modify the Codelogic of a Specific Validation Check, What Needs to Be Done?” on
page 23.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Building a Validation
Process” in Chapter 6, “Validation.”
How Do I Use My Own Style Sheet with a SAS Clinical Standards
Toolkit-Generated define.xml File?
The SAS Clinical Standards Toolkit uses the macro crtdds_write to create a define.xml
file. This macro has the optional parameter _cstCreateDisplayStyleSheet that determines
two things:
•
whether the macro creates a style sheet in the same folder as the output define.xml
file
•
whether the macro creates a reference to that style sheet in the define.xml file
If you set this macro parameter to 1, the macro looks in the supplied SASreferences file
for a record with a type/subtype of referencexml/stylesheet and uses that file.
By default, the crtdds_write macro creates a style sheet reference in the define.xml file
and copies a style sheet in the same folder as the define.xml file. This default style sheet,
define1-0-0.xsl, is copied from the <global library>/standards/cdisccrtdds-1.0/stylesheet folder and is identical to the style sheet that was originally
made available by CDISC as part of the first release of the define.xml file.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Writing XML Files”
in Chapter 7, “XML-Based Standards.”
Can I Associate a Style Sheet with an ODM XML File Generated by
the SAS Clinical Standards Toolkit?
Although it is not common to associate a style sheet with an ODM XML file, the SAS
Clinical Standards Toolkit allows this. To do this, you must call the macro odm_write
with macro parameter cstCreateDisplayStyleSheet=1 and also add a record to the
SASreferences file with type/subtype of referencexml/stylesheet pointing to the
style sheet to be used.
Note: SAS does not supply a default style sheet for ODM.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Module ODM V1.3.0
(Run Time)” in Appendix 3, “Macro Application Programming Interface.”
How Do I Add Supplemental Data (Not Directly Derivable from Other
Standards Such as CDISC SDTM) Used to Create a define.xml File?
When the SAS Clinical Standards Toolkit creates a define.xml file, it converts the
information from a SAS data set representation of the CRT-DDS model into XML. For
CDISC CRT-DDS 1.0, this means that 39 data sets (such as ItemDefs) are the source for
creating the define.xml element and attribute structure. The content of these 39 data sets
can be derived in part from other standards (such as CDISC SDTM).
You can directly maintain these 39 data sets so that you can add additional data that
needs to be part of the define.xml. To be able to maintain these 39 data sets, you must be
Creating and Modifying Files
21
familiar with the structure of these data sets and the relationships among these data sets.
For example, to add Value Level Metadata to the define.xml, add rows to four data sets:
itemdefs, valuelists, valuelistitemrefs, and itemvaluelistrefs.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See Appendix 9, “CRTDDS 1.0 SAS Data Sets,” and “Writing XML Files” in Chapter 7, “XML-Based
Standards.”
How Do I Create the Data Sets That Are Used to Create an ODM XML
File?
When the SAS Clinical Standards Toolkit creates an ODM XML file, it converts the
information from a SAS data set representation of the ODM model into XML. For
CDISC ODM 1.3.0, this means that 66 data sets (such as ItemDefs) are the source for
creating the ODM XML element and attribute structure.
You can directly maintain these 66 data sets so that you can add data that needs to be
part of the ODM XML file. To be able to maintain these 66 data sets, you must be
familiar with the structure of these data sets and the relationships among these data sets.
Normally, you would not use SAS to create an ODM XML file, because it is assumed
that there is a workflow in which a data collection and management system exports
metadata definitions and data content in the form of a transactional or snapshot ODM
XML file. When SAS is used to create an ODM XML file, the initial SAS representation
of the ODM model can be created by using one of the following methods:
•
Call %cst_createTablesForDataStandard(_cstStandard=CDISC-ODM,
_cstStandardVersion=1.3.0, _cstOutputLibrary=work); to build zero-observation
SAS data sets.
•
Call the %odm_read macro to import an ODM XML file that can serve as a template
for the creation of the SAS representation of the ODM XML data model.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Writing XML Files”
in Chapter 7, “XML-Based Standards.”
How Do I Modify the autocall Path to Point to My Own Macros?
The SAS Clinical Standards Toolkit autocall path is set by default to SASAUTOS, which
includes the SAS Clinical Standards Toolkit framework macros found (on Microsoft
Windows) in !sasroot\cstframework\sasmacro.
A macro library is defined for each standard in the Global Library. (See “Where Do the
Framework and Standard-Specific Macros Reside?” on page 23.) In the
SASReferences data set, one or more records with type=autocall can be used to reset the
SAS autocall path, where the order column specifies the order each macro library is to
be referenced. You can use the same strategy to reference any user-defined macro
libraries, even if those libraries are not associated with a specific standard.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See Chapter 5,
“SASReferences File.”
Do I Have to Create and Use a SASReferences Data Set for Any SAS
Clinical Standards Toolkit Process That I Run?
No. However, the SAS Clinical Standards Toolkit has adopted this method to define and
document the input and output file and library references, to build the macro autocall,
and to format search paths for each SAS Clinical Standards Toolkit process. Although
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Chapter 3
•
Frequently Asked Questions
you can perform all library and file allocations and set SAS system options yourself, it is
highly recommended that you use the SASReferences approach.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See Chapter 5,
“SASReferences File.”
Do I Need to Use Properties Files to Define My Own Global Macro
Variables?
No. However, doing so standardizes your approach to creating and documenting global
macro variables.
Within the SAS Clinical Standards Toolkit, either of these two methods is always used
to process properties files:
•
adding a type=properties record to the SASReferences data set, which is then
processed in the routine call to cstutil_processsetup()
•
directly calling cst_setproperties()
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Properties” in
Chapter 3, “Metadata File Descriptions.”
Validation Process
Do I Have to Run All of the SAS Validation Checks for SDTM?
No. The SAS Clinical Standards Toolkit offers the full set of CDISC SDTM 3.1.2
validation checks in the Global Library data set called validation_master found in the
<global library>/standards/cdisc-sdtm-3.1.2-1.4/validation/
control folder.
This set of checks represents an amalgamation of WebSDM, OpenCDISC, and SAS
checks. Some checks assess structural (metadata) compliance, and other checks evaluate
specific data sets, columns, and data values at the “cell” level.
For any given validation process, the SAS Clinical Standards Toolkit expects that you
have defined and referenced (in SASReferences, with type/subtype set to control/
validation) a run-time set of checks that might be some subset of the
validation_master checks. You have the option of both creating this subset and ordering
the checks to be run.
The run-time set of checks might well change over time. For example, once the metadata
structure of the domains is confirmed, those checks need not be run again.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Building a Validation
Process” in Chapter 6, “Validation.”
Can I Run a Validation Process in the SAS Clinical Standards
Toolkit on Multiple Studies Simultaneously?
Yes. The SAS Clinical Standards Toolkit offers several distinct methodologies that
support validating multiple studies. However, these methodologies depend on your data
accrual processes and workflow. It is important that you maintain relationships between
the source study data and the metadata that the SAS Clinical Standards Toolkit requires.
Each column in each data set in each study must be uniquely identifiable.
Macros
23
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Case Study 7:
Validation of Multiple Studies” in Chapter 6, “Validation.”
If I Disagree with or Choose to Modify the Codelogic of a Specific
Validation Check, What Needs to Be Done?
Create your own copy of the standard-specific validation_master data set (which might
be the run-time validation_control data set). Then, make the changes to the copy’s
validation check metadata, including codelogic.
If you believe that the codelogic supplied by SAS is in error and you want SAS to
correct the error, report the problem through normal Technical Support channels.
Approved updates become available with a subsequent hot fix or release of the SAS
Clinical Standards Toolkit.
Macros
Is There Any Debugging Help for SAS Macro Errors?
Debugging errors in SAS macros can be difficult. The SAS Clinical Standards Toolkit
defines the global macro variable_cstDebug to enable these SAS system options: mprint,
mlogic, symbolgen, and mautolocdisplay.
Use these options to significantly increase the number of lines written to the SAS log.
By default, _cstDebug is set to 0, and these options are not enabled.
Common errors might be discussed in various parts of the SAS Clinical Standards
Toolkit 1.4: User's Guide. SAS also maintains a knowledge base that includes productspecific notes regarding installation, problems, and usage. (See “How Do I Report
Problems, Ask Questions, or Get More Information about How to Use the SAS Clinical
Standards Toolkit?” on page 24.)
Other users might have reported or addressed problems on the SAS and Clinical Trials
Community forum (http://communities.sas.com/community/
sas_and_clinical_trials).
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Common Errors and
Solutions” in Chapter 5, “SASReferences File.”
Where Do the Framework and Standard-Specific Macros Reside?
The SAS Clinical Standards Toolkit framework macros can be found here:
•
Microsoft Windows
!sasroot\cstframework\sasmacro, where !sasroot is C:\Program Files
\SASHome\SASFoundation\9.3
•
UNIX
!sasroot/sasautos, where !sasroot is /usr/local/SASHome/
SASFoundation/9.3/
Standard-specific macros can be found in <global library>/standards/
<standard>/macros.
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Frequently Asked Questions
Miscellaneous
How Do I Report Problems, Ask Questions, or Get More Information
about How to Use the SAS Clinical Standards Toolkit?
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See Chapter 1,
“References.”
Can the SAS Clinical Standards Toolkit 1.4 Be Used with Any
Release of SAS Besides SAS 9.3?
The SAS Clinical Standards Toolkit 1.4 release is validated only on SAS 9.3, running on
these platforms:
•
Windows 32
•
Windows for x64
•
Linux for x64
•
Solaris SPARC
•
Solaris AMD
•
HP-UX Itanium
In general, the code base for the SAS Clinical Standards Toolkit is designed to be
backwardly compatible with prior releases of Base SAS, with only limited use of new
features introduced with recent SAS releases. The open-source nature of the product
allows user updates to all product components. “Off-label” use of the product is at the
discretion of the user.
How Is Availability of a New SAS Clinical Standards Toolkit Release
Publicized?
Releases of the SAS Clinical Standards Toolkit occur periodically. Please have your site
representative contact your unit’s SAS account manager for updates on the release
schedule.
Availability of product updates is typically announced on the SAS and Clinical Trials
Community forum (http://communities.sas.com/community/
sas_and_clinical_trials). You can use e-mail notifications and RSS feeds to
ensure that you do not miss any announcements.
The SAS Clinical Standards Toolkit development team members also report on product
updates and availability at industry-specific user conferences such as PharmaSUG and
PhUSE.
Does a New Version of the SAS Clinical Standards Toolkit
Automatically Overwrite Files Installed with a Previous Version?
No. SAS has a strategy of adding the release number to folder names for both
the !sasroot files and the Global Library files. For example:
Miscellaneous
•
25
SAS Clinical Standards Toolkit 1.3
!sasroot/../../SASClinicalStandardsToolkitSDTM312/1.3/sample
<global library>/standards/cdisc-sdtm-3.1.2-1.3
•
SAS Clinical Standards Toolkit 1.4
!sasroot/../../SASClinicalStandardsToolkitSDTM312/1.4/sample
<global library>/standards/cdisc-sdtm-3.1.2-1.4
In addition, SAS does not automatically reset the default version of any previously
installed version of a standard to the current version. Instead, you must make the
decision to upgrade to the current version.
SAS Clinical Standards Toolkit 1.4: User's Guide Reference: See “Unregistering an Old
Version of a Standard, and Then Registering a New Version of a Standard” in Chapter 2,
“Framework.”
26
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•
Frequently Asked Questions
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