- About the Book
- About the Authors
- Chapter 1: Implementation Strategies
- The Case for Standards
- Which Models to Use and Where
- Starting with the Clinical Data Acquisition Standards Harmonization (CDASH) Standard
- Implementation Plans and the Need for Governance
- SDTM Considerations
- ADaM Considerations
- Chapter Summary
- Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation
- SDTM Metadata
- Building Define.xml
- Chapter 3: Implementing the CDISC SDTM with Base SAS
- Base SAS Macros and Tools for SDTM Conversions
- Building SDTM Datasets
- Chapter Summary
- Chapter 4: Implementing CDISC SDTM with the SAS Clinical Standards Toolkit and Base SAS
- SAS Clinical Standards Toolkit Background
- Clinical Standards Setup for Study XYZ123
- Building SDTM Datasets
- Building Define.xml
- Chapter Summary
- Chapter 5: Implementing the CDISC SDTM with SAS Clinical Data Integration
- SAS Clinical Data Integration Introduction
- SAS Clinical Data Integration Metadata
- SAS Clinical Data Integration Study Setup
- Creating SDTM Domains
- Creating the Special-Purpose DM and SUPPDM Domain
- Creating the AE (Adverse Events) Events Domain
- Creating the XP Pain Scale Customized Findings Domain
- Creating the EX Exposure Interventions Domain
- Creating the LB Laboratory Findings Domain
- Creating the Trial Design Model Domains
- Using Customized Code in SDTM Production
- Templating Your SDTM Conversion Jobs for Reuse
- Using SAS Clinical Data Integration to Create Define.xml
- Chapter Summary
- Chapter 6: ADaM Metadata and ADaM Define.xml
- Metadata Spreadsheets
- Define.xml Navigation and Rendering
- Chapter Summary
- Chapter 7: Implementing ADaM with Base SAS
- ADaM Tools
- ADSL – The Subject-Level Dataset
- The ADaM Basic Data Structure (BDS)
- ADAE – Adverse Event Analysis Datasets
- ADTTE – The Time-to-Event Analysis Dataset
- Chapter Summary
- Chapter 8: CDISC Validation Using SAS
- SAS Clinical Standards Toolkit SDTM Validation
- SAS Clinical Data Integration SDTM Validation
- Chapter Summary
- Chapter 9: CDISC Validation Using Pinnacle 21 Community
- Getting Started with Pinnacle 21 Community
- ADaM Validation with Pinnacle 21 Community
- ADaM Traceability Checks with SAS
- Define.xml Validation with Pinnacle 21 Community
- Chapter Summary
- Chapter 10: CDISC Data Review and Analysis
- Safety Evaluations with JMP Clinical
- One PROC Away with ADaM Data Sets
- Transposing the Basic Data Structure for Data Review
- Chapter Summary
- Chapter 11: Integrated Data and Regulatory Submissions
- Regulatory Guidance
- Data Integration Challenges
- Data Integration Strategies
- Data Integration and Submission Tools
- Getting Submission Ready
- Chapter Summary
- Chapter 12: Other Topics
- Standard for Exchange of Non-Clinical Data
- Dataset-XML
- BRIDG Model
- Protocol Representation Model
- FDA Janus Clinical Trials Repository
- CDISC Model Versioning
- Future CDISC Directions
- Chapter Summary
- Appendix A: Source Data Programs
- adverse Dataset
- demographics Dataset
- dosing Dataset
- laboratory Dataset
- pain scores Dataset
- Appendix B: SDTM Metadata
- Appendix B.1 - Table of Contents Metadata
- Appendix B.2 - Variable-Level Metadata
- Appendix B.3 - Codelist Metadata
- Appendix B.4 - Value-Level Metadata
- Appendix B.5 - Computational Method Metadata
- Appendix B.6 - Define Header Metadata
- Appendix C: ADaM Metadata
- Appendix C.1 - Define Header Metadata
- Appendix C.2 - Table of Contents Metadata
- Appendix C.3 - Variable-Level Metadata
- Appendix C.4 - Parameter-Level Metadata
- Appendix C.5 - Computational Method Metadata
- Appendix C.6 - Codelist Metadata
- Appendix C.7 - Analysis Results Metadata
- Appendix C.8 - External Links Metadata
- Appendix D: %run_p21v.SAS macro
- %run_p21v.SAS Macro
- Index
Implementing CDISC Using SAS®
An End-to-End Guide
Second Edition
Chris Holland • Jack Shostak
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