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SAS(R) Clinical Data Integration Essentials

Course Details
Code: CLINDI26
Tuition (USD): $2,400.00 • Classroom (3 days)
Course Details
GSA (USD): $2,176.32 • Classroom (3 days)

This course is a comprehensive introduction to the SAS Clinical Data Integration solution, which makes full use of the SAS Data Integration Studio application and adds additional functionality related to clinical data integration. This course introduces the essentials for using SAS Data Integration Studio to register source and target tables and to create and manage jobs that transform source tables and load them into target data structures. SAS Clinical Data Integration supplies pre-defined CDISC standard definitions for SDTM and ADaM table structures and content and this course shows how to leverage those standard definitions to create jobs that transform source data from clinical studies to load those SDTM and ADaM standard structures, to validate the structure and content of those data structures based on the standards, and to generate CDISC standard define.xml files describing the SDTM domains and ADaM data sets that are part of clinical submissions.

Skills Gained

  • register source data and target tables
  • create jobs and explore the functionality of the Job Editor
  • work with many of the various transformations
  • create, load, and verify structure and contents of CDISC standard SDTM domains and ADaM data sets
  • create define.xml files for CDISC clinical submissions.

Who Can Benefit

  • Clinical Data Integration administrators and clinical data integration developers

Prerequisites

  • Before attending this course, you should
  • be familiar with clinical studies
  • have some knowledge of the process of preparing CDISC clinical study submissions.

Course Details

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

  • designing jobs with 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

  • loading the DM (Demographics) domain
  • loading the XP (Pain Diary) domain
  • loading the SUPPDM (Supplemental Demographics) 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 Data Set

  • describing ADaM data set standards
  • understanding how implementation of the ADaM standard is supported in SAS Clinical Data Integration
  • defining and loading the subject-level analysis data set
  • defining the questionnaire analysis data set (ADQS) structure
  • creating a job to load the analysis data set
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