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SAS Press
Jack Shostak
SAS
®
Programming
in the Pharmaceutical Industry
The correct bibliographic citation for this manual is as follows: Shostak, Jack. 2005. SAS
®
Programming in the
Pharmaceutical Industry. Cary, NC: SAS Institute Inc.
SAS
®
Programming in the Pharmaceutical Industry
Copyright © 2005, SAS Institute Inc., Cary, NC, USA
ISBN 1-59047-793-6
All rights reserved. Produced in the United States of America.
For a hard-copy book: No part of this publication may be reproduced, stored in a retrieval system, or
transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without the
prior written permission of the publisher, SAS Institute Inc.
For a Web download or e-book: Your use of this publication shall be governed by the terms established by
the vendor at the time you acquire this publication.
U.S. Government Restricted Rights Notice: Use, duplication, or disclosure of this software and related
documentation by the U.S. government is subject to the Agreement with SAS Institute and the restrictions set
forth in FAR 52.227-19, Commercial Computer Software-Restricted Rights (June 1987).
SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513.
1st printing, August 2005
SAS Publishing provides a complete selection of books and electronic products to help customers use SAS
software to its fullest potential. For more information about our e-books, e-learning products, CDs, and hard-
copy books, visit the SAS Publishing Web site at support.sas.com/pubs or call 1-800-727-3228.
SAS
®
and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS
Institute Inc. in the USA and other countries. ® indicates USA registration.
Other brand and product names are registered trademarks or trademarks of their respective companies.
Contents
List of Programs xi
Preface xv
Acknowledgments xvii
Chapter 1 Environment and Guiding Principles 1
The Statistical Programmer’s Working Environment 2
Pharmaceutical Industry Vocabulary 2
Statistical Programmer Work Description 2
The Drug/Device Development Process 3
Industry Regulations and Standards 4
Your Clinical Trial Colleagues 8
Guiding Principles for the Statistical Programmer 10
Understand the Clinical Study 11
Program a Task Once and Reuse Your Code Everywhere 12
Clinical Trial Data Are Dirty 13
Use SAS Macros Judiciously 16
A Good Programmer Is a Good Student 18
Strive to Make Your Programming Readable 18
Chapter 2 Preparing and Classifying Clinical
Trial Data 19
Preparing Clinical Trial Data 20
“Clean” the Data If They Are Needed for Analysis 20
Categorize Data If Necessary 21
Avoid Hardcoding Data 24
iv Contents
Classifying Clinical Trial Data 26
Demographics and Trial-Specific Baseline Data 27
Concomitant or Prior Medication Data 27
Medical History Data 29
Investigational Therapy Drug Log 30
Laboratory Data 31
Adverse Event Data 32
Endpoint/Event Assessment Data 35
Clinical Endpoint Committee (CEC) Data 36
Study Termination Data 37
Treatment Randomization Data 38
Quality-of-Life Data 40
Chapter 3 Importing Data 41
Importing Relational Databases and Clinical Data
Management Systems 42
SAS/ACCESS SQL Pass-Through Facility 42
SAS/ACCESS LIBNAME Statement 43
Importing ASCII Text 44
PROC IMPORT and the Import Wizard 44
SAS DATA Step 52
SAS Enterprise Guide 53
Importing Microsoft Office Files 56
LIBNAME Statement 58
Import Wizard and PROC IMPORT 59
SAS/ACCESS SQL Pass-Through Facility 64
SAS Enterprise Guide 65
Importing XML 68
XML LIBNAME Engine 69
SAS XML Mapper 72
PROC CDISC 74
Importing Files in Other Proprietary Data Formats 79
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