From Validating Clinical Trial Data Reporting with SAS. Full book available for purchase here.

Transcription

1 From Validating Clinical Trial Data Reporting with SAS. Full book available for purchase here. Contents Preface ix Acknowledgments xi Chapter 1 Pharmaceutical Industry Overview Introduction Regulations Health Insurance Portability and Accountability Act The Code of Federal Regulations Guidance for Industry International Conference on Harmonisation of Technical Requirements Clinical Data Interchange Standards Consortium Documentation Standard Operating Procedures Companywide Standard Operating Procedures Department Standard Operating Procedures Task Standard Operating Procedures SAS Programming Guidelines Quality Control versus Quality Assurance Patient versus Subject Conclusion 10 Chapter 2 Validation Overview Introduction Validation versus Verification Why Is Validation Needed? Presenting Correct Information Validating Early Saves Time Developing a Positive Relationship 14

2 iv Contents 2.4 How Do You Approach Validation? Start with All the Information Have a Plan Make the Code Do the Work Ask Questions Be Proactive Validation Must Come First Validation Methods Independent Programming Peer Review Validation Checklists Software Development Life Cycle Conclusion 22 Chapter 3 Documentation and Maintenance Introduction Starting the Process Study Protocol Annotated Case Report Form Statistical Analysis Plan Meeting Minutes Internal Program Documentation Program Header Body Comments Output Titles External Documentation Data Definition Tables Program Directory Validation Files Make Programs Maintainable Create and Follow Naming Conventions Make It Easy to Read 38

3 Contents v One Program, One Purpose Comments, Comments, Comments Use Macros Judiciously Make Data Maintainable Order Your Data Label Everything Attach Formats Sparingly Consistency Is Key Good Housekeeping Look but Don t Touch Conclusion 56 Chapter 4 General Techniques to Facilitate Validation Introduction Validation Tools Procedures SAS Options and Language Elements Using Macros Effectively Techniques That Facilitate Validation Start with a Clean Log Print Only What You Need When You Need It Tracking Problems Using PROC TRANSPOSE or an Alternative Solution Tracking Dropped Data Conclusion 93 Chapter 5 Data Import and Export Introduction Validating the Import Process Validating the Export Process General Items to Watch For When Transferring Data 99

4 vi Contents 5.5 Working with SAS Files SAS Data Sets SAS Transport Files Working with Other File Types Microsoft Excel Files Flat Files Common Procedures Used for Validating Data Transfers PROC CONTENTS PROC COMPARE Conclusion 112 Chapter 6 Common Data Types Introduction Study Populations Safety Intent-to-Treat Efficacy Common Data Domains Subject Demographics Inclusion/Exclusion Criteria Subject Disposition Medical History Physical Examination Vital Signs Treatment Exposure Concomitant Medications Adverse Events Clinical Laboratory Data Conclusion 137

5 Contents vii Chapter 7 Reporting and Statistics Introduction Pre-Output Validation Steps Code Review Log Review Output Validation Steps Understanding the Data Understanding the Output Checking the Result Cross-Checking Related Output Checking the Cosmetics Updating the Specifications Keeping What Is Important Final QC Steps Conclusion 158 Appendix A Sample Quality Control Checklists 159 Appendix B Sample Statistical Analysis Plan 163 Appendix C Glossary 181 References 195 Index 197 From Validating Clinical Trial Data Reporting with SAS by Carol I. Matthews and Brian Shilling. Copyright 2008, SAS Institute Inc., Cary, North Carolina, USA. ALL RIGHTS RESERVED.