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SAS Clinical CDISC/SDTM/ADAM Training

SAS & the Clinical Data Interchange Standards Consortium (CDISC)

United Global Soft delivers a range of SAS training suitable for a variety of users of all abilities.

CDISC standards have been in development for many years. There have been structural changes to the recommended standards going forward from version 2 to 3. It is still an evolving process but it has reached a point of critical mass that organizations are recognizing the benefits of taking the proposed standard data model out of the theoretical and putting it into real life applications. The complexity of clinical data coupled with technologies involved can make implementation of a new standard challenging. This paper will explore the pitfalls and present methodologies and technologies that would make the transformation of nonstandard data into CDISC efficient and accurate.

Course Content

Introduction to Clinical Data Integration

• purpose and functions of SAS Clinical Data Integration
• understanding the software components comprising SAS Clinical Data Integration
• overview of SAS Clinical Data Integration components in SAS Data Integration Studio

Technical Overview of SAS Data Integration Studio

Case Study Overview and Defining Metadata for Source Tables and Domains

• Clinical Data Integration case study description
• overview of the domain loading jobs
• defining source table metadata
• defining target domain metadata

Creating Jobs to Load Domains

• introduction
• loading the DM (Demographics) domain
• loading the XP (Pain Diary) domain
• loading the SUPPDM (Supplemental Demographics) domain
• loading the QS (Questionnaire) domain

Change Management

• exploring the basics of change management

Domain Compliance Checks

• introduction to CDISC-SDTM compliance checks
• compliance checks for the DM domain
• compliance checks for the QS domain
• compliance checks for an externally supplied domain

Generating CRT-DDS Define.xml Files

• creating a standard CRT-DDS Define.xml document
• creating customized CRT-DDS Define.xml documents

Definining and Loading an ADaM Dataset

• defining an analysis dataset using the ADaM standard
• creating a job to load the analysis dataset