Assumptions and Notes :: SAS(R) Clinical Standards Toolkit 1.5: Operational Qualification

General Assumptions

The second maintenance release for SAS 9.3 has been installed and is functioning correctly. It is not being tested.
The SAS Clinical Standards Toolkit 1.5 has been installed, including the sample study libraries.
The person running these tests is familiar with running SAS programs. This includes being able to submit SAS programs via the Program Editor, review the SAS log, and review the contents of SAS data sets.

File Path Separator

This document is used for both the UNIX and Microsoft Windows environments. The forward slash character ( / ) is used in file paths as the separator between path components, which works in both operating system environments.

SASINSTALL and SASROOT within This Document

SASINSTALL is used to denote the SAS installation directory. This is the directory into which all SAS products are installed.

The default value in SAS 9.3 on Microsoft Windows is C:/Program Files/SASHome.

The default value varies on UNIX computers. Please consult your system administrator.
SASROOT is used to denote the root directory for the SAS System installation.

The default value in SAS 9.3 is SASINSTALL/SASFoundation/9.3.
sample study library directory is used to denote the sample study libraries available with the SAS Clinical Standards Toolkit 1.5.

The default value for the SAS Clinical Standards Toolkit 1.5 on Microsoft Windows is C:/cstSampleLibrary.

Variables Referred to by the Tests

The tests refer to the following variables, which are defined relative to sample study library directory. When running the tests, substitute the variables with these associated paths:

CST_FRAMEWORK

sample study library directory/cdisc-sdtm-3.1.1–1.5/sascstdemodata
CST_SDTM

sample study library directory/cdisc-sdtm-3.1.2–1.5/sascstdemodata
CST_ODM_130

sample study library directory/cdisc-odm-1.3.0–1.5
CST_ODM

sample study library directory/cdisc-odm-1.3.1–1.5
CST_CRTDDS

sample study library directory/cdisc-crtdds-1.0–1.5

Generation of a PDF File

The last manual test (see Test 5: Report Check Metadata) generates a PDF file. On Microsoft Windows, when a PDF file is generated, the PDF should automatically appear in a browser window. On UNIX, if you have not set up the SAS configuration variable SAS.helpBrowser, you see this message:

The requested
                     information could not be displayed because the connection to the remote
                     browser server failed.

Click OK to continue.

Configure your UNIX SAS environment to support a browser that can display PDF files. Or, copy the PDF file to an environment where you can display it.