Contents
Chapter 1: Implementation Strategies
Starting with the Clinical Data Acquisition Standards Harmonization (CDASH) Standard
Implementation Plans and the Need for Governance
Chapter 2: SDTM Metadata and Define.xml for Base SAS Implementation
Chapter 3: Implementing the CDISC SDTM with Base SAS
Base SAS Macros and Tools for SDTM Conversions
Creating an SDTM Codelist SAS Format Catalog
Creating an Empty SDTM Domain Dataset
Creating an SDTM --DTC Date Variable
Creating an SDTM Study Day Variable
Sorting the Final SDTM Domain Dataset
Building the Special-Purpose DM and SUPPDM Domains
Building the LB Findings Domain
Building a Custom XP Findings Domain
Building the EX Exposure Interventions Domain
Building Trial Design Model (TDM) Domains
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
Base SAS Macros and Tools for SDTM Conversions
Building the Special-Purpose DM and SUPPDM Domains
Chapter 5: Implementing the CDISC SDTM with SAS Clinical Data Integration
SAS Clinical Data Integration Introduction
SAS Clinical Data Integration Metadata
Classifications of SAS Clinical Data Integration Metadata
Setup of SAS Clinical Data Integration Metadata
SAS Clinical Data Integration Study Setup
Define the Clinical Study and Subfolders
Register Source Datasets and Define Target SDTM Datasets
Setting SAS Clinical Data Integration Defaults
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 6: ADaM Metadata and ADaM Define.xml
Analysis Parameter Value-Level Metadata
Define.xml Navigation and Rendering
Chapter 7: Implementing ADaM with Base SAS
ISO 8601 Date and DateTime Conversions
Merging in Supplemental Qualifiers
ADSL – The Subject-Level Dataset
The ADaM Basic Data Structure (BDS)
ADAE – Adverse Event Analysis Datasets
ADTTE – The Time-to-Event Analysis Dataset
Chapter 8: CDISC Validation Using SAS
SAS Clinical Standards Toolkit SDTM Validation
SAS Clinical Standards Toolkit Setup
SAS Clinical Standards Toolkit SDTM Validation Program
SAS Clinical Data Integration SDTM Validation
SAS Clinical Standards Toolkit Define.xml Validation Program
SAS Clinical Data Integration Define.xml Validation
Chapter 9: CDISC Validation Using Pinnacle 21 Community
Getting Started with Pinnacle 21 Community
Running Pinnacle 21 Community (Graphical User Interface)
Modifying the Configuration Files
A Note about Controlled Terminology
Running Pinnacle 21 Community (Command-Line Mode)
ADaM Validation with Pinnacle 21 Community
ADaM Traceability Checks with SAS
Define.xml Validation with Pinnacle 21 Community
Chapter 10: CDISC Data Review and Analysis
Safety Evaluations with JMP Clinical
Getting Started with JMP Clinical
One PROC Away with ADaM Data Sets
Transposing the Basic Data Structure for Data Review
Progression Free Survival with Investigator and Central Assessment
Chapter 11: Integrated Data and Regulatory Submissions
Representing Subjects Who Appear in Multiple Studies in Subject-Level Data Sets
Deciding Which Data to Integrate
Summary of Data Integration Strategies
Data Integration and Submission Tools
Setting Variable Lengths Based on the Longest Observed Value
Converting from Native SAS to Version 5.0 Transport Files
Converting from Version 5.0 Transport Files to Native SAS
Standard for Exchange of Non-Clinical Data
FDA Janus Clinical Trials Repository
Appendix A: Source Data Programs
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.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