Documents

• Sample Chapter
  • 1 Introduction to the Drug Development Process (very rough draft)
  • 2 Different Paths to Clinical SAS Programming (updated English edits)
  • 3 A Day in a Life of a Clinical Analyst (updated English/Grammar edits)
  • 4 Getting Acquainted with Software
  • 5 Data Management vs. Data Analysis (updated English/Grammar edits)
  • 6 Visual Guide to Clinical Programming
  • 7 What is the Big Deal with CDISC and Data Standards
  • 8 Mindset and Career Considerations
  • 9 Validation and Regulatory Requirements
• Administrative Documents
  • Status Spreadsheet
  • Author Questionaire
  • http://sasbioanalyst.blogspot.com/ 
  • Example Book Covers
  • Lulu.com Shipping Cost: One, Five, Ten, One Hundred
• CDISC Implementation Paper Index

1. Author Index - This index is used to manage communications with contributing authors
2. Lesson Learned from Implementation
   1. Mapping CDISC Metadata Attributes: Using Data _Null_ and Proc Datasets in SAS
      Rita Tsang: Rita.Tsang@averionintl.com 
   2. Implementing CDISC When You Already Have Standards: A Case Study
      Sandra Minjoe: sminjoe@gene.com
   3. The Second CDISC Pilot Project A Metastandard for Integrating Databases
      Greg Steffens: steffensgc@lilly.com
      Ian Fleming: fleming.ian@gene.com
   4. Backpacking Your Way Through CDISC: A Budget-Minded Guide to Basic Concepts and Implementation
      Rachel Brown, MS: RachelBrown@westat.com
      Jennifer Fulton, MS: JenniferFulton@westat.com
   5. CDISC: Pains and Pitfalls to Dataset Creation
      Janet Stuelpner: janet@lefthandcomputing.com
      Steven Michaelson: smichaelson@simulstat.com
   6. Metadata Application on Clinical Trial Data in Drug Development
      Julia Zhang: julia_z_zhang@gsk.com
      David Chen: david_chen-1@gsk.com
      Tor-Lai Wong: tor-lai_2_wong@gsk.com
   7. The Design and Use of Metadata ? Part Fine Art, Part Black Art
      Frank DiIorio: Frank@CodeCraftersInc.com
      Jeff Abolafia: JAbolafi@RhoWorld.com
   8. Managing the Change and Growth of a Metadata-based System
      Jeff Abolafia: Jeff_Abolafia@RhoWorld.com
      Frank DiIorio: frank@CodeCraftersInc.com
   9. StARScope: A Web-Based SAS(r) Prototype for Clinical Data Visualization
      Fang Dong, PhD: fang.dong@Pfizer.com
         
3. Methodologies
   1. Practical Methods for Creating CDISC SDTM Data Sets from Existing Data
      Robert Graebner: bob.graebner@quintiles.com
                                   mgraebner@kc.rr.com
   2. XML in the DATA Step
      Michael Palmer: mcpalmer@zbi.net
   3. Standard Management-Approved Report Templates: The SMART System
      Gary Stevens: gary.stevens@biogenidec.com
   4. The Electronic Project: Effectively Using Metadata throughout the Project Life Cycle
      Frank DiIorio: Frank@CodeCraftersInc.com
      Jeff Abolafia: JAbolafi@RhoWorld.com
   5. A Table-Driven Solution for Clinical Data Submission
      Dr. Jim Sattler: jsattler@saberconsult.com
   6. XML for SAS® Programmers
      Frederick Pratter: fpratter@eou.edu
   7. Data Management in Analyzing Clinic Trial Data - Metadata Application
      Julia Zhang: julia.z.zhang@gsk.com
      David Chen: david.c.chen@gsk.com
   8. SAS® Data Integration Studio and SAS® Macro ? Working in Harmony for Data Warehousing Projects
      Tatyana Kovtun: tatyana_kovtun@berlex.com
   9. Using Excel XP to Display SDTM Metadata and More
      Christine Teng: christine_teng@merck.com
      Shaoan Yu: Shaoan_yu@merck.com
   10. SAS® XML Mapper to the Rescue
       Carol A. Martell: carol_martell@unc.edu
   11. Customizing ODS Statistical Graphics
       Shi-Tao Yeh, Ph. D.: shi-tao_yeh-1@gsk.com
   12. An Interpretation of Sparkline Graphs and Their Creation with SAS® Software
       Paul OldenKamp: POK_Programming@OldenKamp.org
   13. Designing a Global SAS®9 Architecture for Clinical Trials Analysis and Reporting
       Greg Nelson: greg@thotwave.com
       Michael Walega: Michael.Walega@covance.com
   14. Developing, Managing, and Evaluating a Standard Macro System
       Albert Mo: albert.mo@abgenix.com
                         albertmo@verizon.net
   15. A Tiptoe Through the Tagset Field
       Mike Molter: mike.molter@rtp.ppdi.com  
   16. A SAS® Programmer’s Guide to Generating Define.xml
       Mike Molter: mike.molter@nesug.org
   17. Extending SAS® Data Integration Studio with Java: Custom GUIs and SAS Server Interaction
       Christopher Treglio: chris_treglio@berlex.com
   18. Customizing DI Studio with a Plug-in to Turn off AutoMap
       Chris Olinger: colinger@d-wise.com
       Stephen Baker: sbaker@d-wise.com