1. Communicating with Standards Keeping it Simple Pamela Ryley Vertex Pharmaceuticals, Inc. September 29, 2006

2. Pamela Ryley 29 Sept 2006 Implementing CDISC Why? What Point in Study to apply CDISC Preparation for submission Database extraction Data collection / Database creation STDM – Okay What about the rest of CDISC? Trial Design, ADaM, LAB Model

3. Pamela Ryley 29 Sept 2006 Concurrent Changes New Electronic Data Capture system New Electronic Reporting and Repository system New Standards - CDISC Opportunity to determine where to implement CDISC Push CDISC strategy back to data collection – data collection items being redefined anyway.

4. Pamela Ryley 29 Sept 2006 Implementing STDM in Data Collection Identifying and implementing the use of one to one matches Implementing logical naming and structure where one to one matches not possible. Identifying limitations of chosen EDC database and preparing for those.

5. Pamela Ryley 29 Sept 2006 Implementing STDM in Data Collection Collection variables to reporting variables eCRF Data Controlled terminology Electronically loaded data Efficiency and Reduced Cost

6. Pamela Ryley 29 Sept 2006 Implementing STDM in Data Collection Close collaboration between Data Management, Statisticians and Statistical Programming to streamline processing from data capture to reporting. Education and acceptance of other groups. Recognition of need and willingness to replace earlier standards

7. Pamela Ryley 29 Sept 2006 Challenges of Implementing STDM in Data Collection Items without a one to one correlation Variables that require transposition Items collected for operational use Greater detail than required by CDISC Submissions to other agencies Exploratory use or Publication Items of Operational Value

8. Pamela Ryley 29 Sept 2006 Extending the Implementation Legacy data Mapping Variables One to many Many to One Controlled Terminology Add Trial Design Datasets

9. Pamela Ryley 29 Sept 2006 Extending the Implementation Increases ability to easily combine data across protocols early in compound development. Creation of updated set of standard programs that take advantage of features in SAS version 9.

10. Pamela Ryley 29 Sept 2006 Confirming Structure General Conformance SAS v9 Proc CDISC Web SDM Combining data across protocols Combining legacy and current data Data as required Structure & Content

11. Pamela Ryley 29 Sept 2006 Programming Benefits of Pushing CDISC standards to data collection Minimize preparation of submission datasets Time Resources used for more valuable endeavors Consistency & Transparency

12. Pamela Ryley 29 Sept 2006 Risks of Implementing CDISC in Data Capture Changes to CDISC New domains Modifications to Draft Domains Modifications to controlled terminology Broader Limitations SAS V5 Transport files xml files 8 character limitations on numerous variables Changes to Trial Design, ADaM, LAB Model

13. Pamela Ryley 29 Sept 2006 Challenges Trial Design Datasets Reserved domains Determining when to use supplemental qualifiers versus creating new domains Complex Design of Protocols – difficult to fit into CDISC standards No single source for answers to questions. We do have user groups

14. Pamela Ryley 29 Sept 2006 Thank You!