You are previewing Implementing CDISC Using SAS.
O'Reilly logo
Implementing CDISC Using SAS

Book Description

An all-inclusive guide on how to implement and analyze Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submissions. Topics covered include creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission.

Table of Contents

  1. Copyright
  2. Dedication
  3. Contents
  4. About This Book
  5. About The Authors
  6. Acknowledgments
  7. Chapter 1: Implementation Strategies
    1. Why “CDISC It”?
    2. Which Models to Use and Where
    3. Starting with the Clinical Data Acquisition Standards Harmonization (CDASH) Standard
    4. Implementation Plans and the Need for Governance
    5. SDTM Considerations
    6. ADaM Considerations
    7. Chapter Summary
  8. Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation
    1. SDTM Metadata
    2. Building define.xml
    3. Chapter Summary
  9. Chapter 3: Implementing the CDISC SDTM with Base SAS
    1. Base SAS Macros and Tools for SDTM Conversions
    2. Building SDTM Datasets
    3. Chapter Summary
  10. Chapter 4: Implementing CDISC SDTM with the SAS Clinical Standards Toolkit and Base SAS
    1. SAS Clinical Standards Toolkit Background
    2. Clinical Standards Setup for Study XYZ123
    3. Building SDTM Datasets
    4. Base SAS Macros and Tools for SDTM Conversions
    5. Building the Special-Purpose DM and SUPPDM Domains
    6. Building define.xml
    7. Chapter Summary
  11. Chapter 5: Implementing the CDISC SDTM with SAS Clnical Data Integration
    1. SAS Clinical Data Integration Introduction
    2. SAS Clinical Data Integration Metadata
    3. SAS Clinical Data Integration Study Setup
    4. Creating SDTM Domains
    5. Using SAS Clinical Data Integration to Create define.xml
    6. Chapter Summary
  12. Chapter 6: ADaM Metadata and ADaM Define.xml
    1. Metadata Spreadsheets
    2. Define.xml Navigation and Rendering
    3. Chapter Summary
  13. Chapter 7: Implementing ADaM
    1. ADaM Tools
    2. ADSL – The Subject-Level Dataset
    3. The ADaM Basic Data Structure (BDS)
    4. ADAE – Adverse Event Analysis Datasets
    5. ADTTE – The Time-to-Event Analysis Dataset
    6. Chapter Summary
  14. Chapter 8: SDTM Validation
    1. SAS Clinical Standards Toolkit
    2. SAS Clinical Data Integration
    3. OpenCDISC Validator
    4. Chapter Summary
  15. Chapter 9: Validating ADaM Data
    1. ADaM's Published Validation Checks
    2. OpenCDISC Validator
    3. Running the OpenCDISC Validator as a Macro
    4. Traceability Checks
    5. Chapter Summary
  16. Chapter 10: CDISC Data Review and Analysis
    1. Safety Evaluations with JMP Clinical
    2. One PROC Away with ADaM Datasets
    3. Chapter Summary
  17. Chapter 11: Integrated Data and Regulatory Submissions
    1. Regulatory Guidance
    2. Data Integration Challenges
    3. Data Integration Strategies
    4. Data Integration and Submission Tools
    5. Getting Submission Ready
    6. Chapter Summary
  18. Chapter 12: Other Topics
    1. Standard for Exchange of Non-Clinical Data
    2. HL7 Messaging
    3. BRIDG Model
    4. Protocol Representation Model
    5. FDA Janus Clinical Trials Repository
    6. CDISC Model Versioning
    7. Future CDISC Directions
    8. Chapter Summary
  19. Appendix A: Source Data Programs
    1. adverse Dataset
    2. demographics Dataset
    3. dosing Dataset
    4. laboratory Dataset
    5. pain scores Dataset
  20. Appendix B: SDTM Metadata
    1. Appendix B.1 - Table of Contents Metadata
    2. Appendix B.2 - Variable-Level Metadata
    3. Appendix B.3 - Codelist Metadata
    4. Appendix B.4 - Value-Level Metadata
    5. Appendix B.5 - Computational Method Metadata
    6. Appendix B.6 - Define Header Metadata
  21. Appendix C: ADaM Metadata
    1. Appendix C.1 - Define Header Metadata
    2. Appendix C.2 - Table of Contents Metadata
    3. Appendix C.3 - Variable-Level Metadata
    4. Appendix C.4 - Parameter-Level Metadata
    5. Appendix C.5 - Computational Method Metadata
    6. Appendix C.6 - Codelist Metadata
    7. Appendix C.7 - Analysis Results Metadata
    8. Appendix C.8 - External Links Metadata
  22. Appendix D: %make_define SAS Macro
    1. %make_define SAS Macro
    2. Additional SAS Code Comments
  23. Index
  24. Accelerate Your SAS Knowledge with SAS Books