Implementing CDISC Using SAS

Chris Holland, Jack Shostak

Description

For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards
Consortium (CDISC) standards.

Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers 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. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly.

Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.

Sujets

• Clinical Data Interchange Standards Consortium
• Clinical trial
• Pharmaceutical drug

Informations

• Publié par: SAS Institute
• Date de parution: 30 mai 2019
• Nombre de lectures: 0
• EAN13: 9781642952414
• Langue: English
• Poids de l'ouvrage: 19 Mo

Extrait

Implementing CDISC Using SAS
An End-to-End Guide
Revised Second Edition
Chris Holland Jack Shostak
support.sas.com/bookstore
The correct bibliographic citation for this manual is as follows: Holland, Chris and Jack Shostak. 2016. Implementing CDISC Using SAS : An End-to-End Guide, Revised Second Edition . Cary, NC: SAS Institute Inc.
Implementing CDISC Using SAS : An End-to-End Guide, Revised Second Edition
Copyright 2016, SAS Institute Inc., Cary, NC, USA
ISBN 978-1-64295-265-0 (Hardcover) ISBN 978-1-62959-825-3 (Paperback) ISBN 978-1-62960-536-4 (EPUB) ISBN 978-1-62960-537-1 (MOBI) ISBN 978-1-62960-538-8 (PDF)
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Contents
About This Book
About These 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
Table of Contents Metadata
Variable-Level Metadata
Codelist Metadata
Value-Level Metadata
Where Clause Metadata
Computational Method Metadata
Comments Metadata
External Links
Building Define.xml
Define File Header Metadata
Define File Creation SAS Program
Chapter Summary
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 SDTM Datasets
Building the Special-Purpose DM and SUPPDM Domains
Building the LB Findings Domain
Building a Custom XP Findings Domain
Building the AE Events Domain
Building the EX Exposure Interventions Domain
Building Trial Design Model (TDM) Domains
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
Base SAS Macros and Tools for SDTM Conversions
Building the Special-Purpose DM and SUPPDM Domains
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
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 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
Variable Metadata in ADaM
Analysis Parameter Value-Level Metadata
Analysis Results Metadata
Building Define.xml
Define.xml Navigation and Rendering
Chapter Summary
Chapter 7: Implementing ADaM with Base SAS
ADaM Tools
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 Summary
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 Summary
Chapter 9: CDISC Validation Using Pinnacle 21 Community
Getting Started with Pinnacle 21 Community
Running Pinnacle 21 Community (Graphical User Interface)
Evaluating the Report
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 Summary
Chapter 10: CDISC Data Review and Analysis
Safety Evaluations with JMP Clinical
Getting Started with JMP Clinical
Safety Analyses
Patient Profiles
Event Narratives
One PROC Away with ADaM Data Sets
Transposing the Basic Data Structure for Data Review
Progression Free Survival with Investigator and Central Assessment
Chapter Summary
Chapter 11: Integrated Data and Regulatory Submissions
Regulatory Guidance
Data Integration Challenges
Data Integration Strategies
Representing Subjects Who Appear in Multiple Studies in Subject-Level Data Sets
Deciding Which Data to Integrate
Coding Dictionary Issues
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
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 - Define Header Metadata
Appendix B.2 - Table of Contents Metadata
Appendix B.3 - Variable-Level Metadata
Appendix B.4 - Value-Level Metadata
Appendix B.5 - Computational Method Metadata
Appendix B.6 - Codelist Metadata
Appendix B.7 - Where Clause Metadata
Appendix B.8 - Comment Metadata
Appendix B.6 - External Links 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 - Where Clause Metadata
Appendix C.7 - Comments Metadata
Appendix C.8 - Codelist Metadata
Appendix C.9 - Analysis Results M