MXI ConfidentialCopyright Material
February 11, 2010
1
SAS Clinical Standards Toolkit 2.1 Tutorial
Sy Truong, President of MXI
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Agenda
• SAS 9.2 Update• SAS Clinical Standards Toolkit 2.1
Tutorial
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SAS 9.2 Update
• SAS 9.2 Install• IQ/OQ • PQ • Citrix and SAS• Clinical Standard Toolkit
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Getting Started Overview
• Introductory Tutorial on SAS® Clinical Standards Toolkit 1.2 (CST)
• Intended for basic steps for using CST
• Preparation of data and metadata
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Getting Started Tutorial Goal and Exercises
• How to use CST to validate your own data.• The tutorial consists of the following four
steps:– Install tutorial.– Exercise 1: Prepare the study data and
metadata.– Exercise 2: Walk through the steps needed to
setup CST to run a CDISC SDTM 3.1.1 Validation.
– Exercise 3: Consolidate and simplify the steps from Exercise 2 into a single program.
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Install Tutorial
• Install the directories and files by extract the following applicable file into the c:\ directory:– For SAS 9.2: cstQuickStartSDTMValidation.zip– For SAS 9.1.3:
cstQuickStartSDTMValidation913.zip• The extraction creates the following directory:
– For SAS 9.2: c:\cstQuickStart– For SAS 9.1.3: c:\cstQuickStart913
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• The Subdirectories and Files:– Table 1. Quick Start Tutorial Folder
Structure
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• Default Directories and Installation:– Table 2. Installed Software and the
Associated Default Directory
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Exercise 1 – Prepare Study Data and Metadata
• Data must be in CDISC SDTM 3.1.1-formatted SAS data sets.
• Prepare data by your own or use SAS® Clinical Data Integration.
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• Exercise 1A – Prepare Data– Copy the Data from the Sample Study
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• Exercise 1B – Prepare Format Catalogs– Copy the Data from the Sample Study
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• Exercise 1C – Prepare Metadata Files– Copy the SAS Standardized set of
Metadata
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Exercise 2 – Step by Step
• Execute a CST SDTM validation against the data that was configured in Exercise 1.
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• Exercise 2A – Create a SAS References data set– The SAS References data set must
contain a row that references itself.
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• Exercise 2B – Select the Validation Checks– Select the validation checks to run against
the MyStudy data.– The validation_master is not used directly by
the validation process itself.– Some rows in the validation_master have the
same validation check but different in other details.
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• Exercise 2C – Run Validation– Validate MyStudy data against CDISC SDTM
3.1.1.– Properties show how CST performs various
tasks.
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Exercise 3 – All in One
• Combine all of the steps from Exercise 2 into a single program.
• Update the data set by changing a few values in Exercise 2A.
• Demonstrates how to run all of the JANUS checks.
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Conclusion
• Provide Overview on Process of Using Clinical Standard Toolkit
• Validation of SDTM 3.1.1 but Can Also Applied to CRT-DDS (DEFINE.XML)
• Additional Information on User Guide in Web Portal (http://meta-x.com/cetero/)