Implementing CDISC Using SAS r An End to End Guide 2nd Edition by Chris Holland, Jack Shostak ISBN ‎ 1642952443 ‎ 978-1642952445

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ISBN 10: ‎ 1642952443
ISBN 13: ‎ 978-1642952445
Author:  Chris Holland, Jack Shostak

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. This allows users to specify dataset order explicitly in their define files via metadata instead of simply where the data first occurs in the spreadsheet.

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.

Implementing CDISC Using SAS(r) An End to End Guide 2nd Table of contents:

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

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