mxi confidential copyright material february 11, 2010 1 sas clinical standards toolkit 2.1 tutorial...

MXI ConfidentialCopyright Material

February 11, 2010

1

SAS Clinical Standards Toolkit 2.1 Tutorial

Sy Truong, President of MXI

www.meta-x.comMXI ConfidentialCopyright Material

Agenda

• SAS 9.2 Update• SAS Clinical Standards Toolkit 2.1

Tutorial

www.meta-x.comMXI ConfidentialCopyright Material

SAS 9.2 Update

• SAS 9.2 Install• IQ/OQ • PQ • Citrix and SAS• Clinical Standard Toolkit

www.meta-x.comMXI ConfidentialCopyright Material

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

www.meta-x.comMXI ConfidentialCopyright Material

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.

www.meta-x.comMXI ConfidentialCopyright Material

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

www.meta-x.comMXI ConfidentialCopyright Material

• The Subdirectories and Files:– Table 1. Quick Start Tutorial Folder

Structure

www.meta-x.comMXI ConfidentialCopyright Material

• Default Directories and Installation:– Table 2. Installed Software and the

Associated Default Directory

www.meta-x.comMXI ConfidentialCopyright Material

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.

www.meta-x.comMXI ConfidentialCopyright Material

• Exercise 1A – Prepare Data– Copy the Data from the Sample Study

www.meta-x.comMXI ConfidentialCopyright Material

• Exercise 1B – Prepare Format Catalogs– Copy the Data from the Sample Study

www.meta-x.comMXI ConfidentialCopyright Material

• Exercise 1C – Prepare Metadata Files– Copy the SAS Standardized set of

Metadata

www.meta-x.comMXI ConfidentialCopyright Material

Exercise 2 – Step by Step

• Execute a CST SDTM validation against the data that was configured in Exercise 1.

www.meta-x.comMXI ConfidentialCopyright Material

• Exercise 2A – Create a SAS References data set– The SAS References data set must

contain a row that references itself.

www.meta-x.comMXI ConfidentialCopyright Material

• 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.

www.meta-x.comMXI ConfidentialCopyright Material

• Exercise 2C – Run Validation– Validate MyStudy data against CDISC SDTM

3.1.1.– Properties show how CST performs various

tasks.

www.meta-x.comMXI ConfidentialCopyright Material

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.

www.meta-x.comMXI ConfidentialCopyright Material

www.meta-x.comMXI ConfidentialCopyright Material

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/)