1. MXI Confidential Copyright Material February 11, 2010 1 SAS Clinical Standards Toolkit 2.1 Tutorial Sy Truong, President of MXI

2. www.meta-x.comMXI Confidential Copyright Material Agenda SAS 9.2 Update SAS Clinical Standards Toolkit 2.1 Tutorial

3. www.meta-x.comMXI Confidential Copyright Material SAS 9.2 Update SAS 9.2 Install IQ/OQ PQ Citrix and SAS Clinical Standard Toolkit

4. www.meta-x.comMXI Confidential Copyright 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

5. www.meta-x.comMXI Confidential Copyright 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.

6. www.meta-x.comMXI Confidential Copyright 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

7. www.meta-x.comMXI Confidential Copyright Material The Subdirectories and Files: –Table 1. Quick Start Tutorial Folder Structure

8. www.meta-x.comMXI Confidential Copyright Material Default Directories and Installation: –Table 2. Installed Software and the Associated Default Directory

9. www.meta-x.comMXI Confidential Copyright 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.

10. www.meta-x.comMXI Confidential Copyright Material Exercise 1A – Prepare Data –Copy the Data from the Sample Study

11. www.meta-x.comMXI Confidential Copyright Material Exercise 1B – Prepare Format Catalogs –Copy the Data from the Sample Study

12. www.meta-x.comMXI Confidential Copyright Material Exercise 1C – Prepare Metadata Files –Copy the SAS Standardized set of Metadata

13. www.meta-x.comMXI Confidential Copyright Material Exercise 2 – Step by Step Execute a CST SDTM validation against the data that was configured in Exercise 1.

14. www.meta-x.comMXI Confidential Copyright Material Exercise 2A – Create a SAS References data set –The SAS References data set must contain a row that references itself.

15. www.meta-x.comMXI Confidential Copyright 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.

16. www.meta-x.comMXI Confidential Copyright Material Exercise 2C – Run Validation –Validate MyStudy data against CDISC SDTM 3.1.1. –Properties show how CST performs various tasks.

17. www.meta-x.comMXI Confidential Copyright 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.

18. www.meta-x.comMXI Confidential Copyright Material

19. www.meta-x.comMXI Confidential Copyright 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/)Web Portal