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  • SAS

    Clinical Data Integration 2.4Users Guide

    SAS Documentation

  • The correct bibliographic citation for this manual is as follows: SAS Institute Inc. 2013. SAS Clinical Data Integration 2.4: User's Guide. Cary, NC: SAS Institute Inc.

    SAS Clinical Data Integration 2.4: User's Guide

    Copyright 2013, SAS Institute Inc., Cary, NC, USA

    All rights reserved. Produced in the United States of America.

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    U.S. Government Restricted Rights Notice: Use, duplication, or disclosure of this software and related documentation by the U.S. government is subject to the Agreement with SAS Institute and the restrictions set forth in FAR 52.227-19, Commercial Computer Software-Restricted Rights (June 1987).

    SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513.

    July 2013

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  • Contents

    PART 1 Introduction 1

    Chapter 1 / Overview: SAS Clinical Data Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3What Is SAS Clinical Data Integration? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Typical Workflow in SAS Clinical Data Integration . . . . . . . . . . . . . . . . . . . . . . 4Recommended Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

    PART 2 Information for Clinical Administrators 7

    Chapter 2 / Data Standards Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Overview: Data Standards Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Importing Data Standards Metadata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Customizing Data Standard Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Customizing Data Standard Domain Templates . . . . . . . . . . . . . . . . . . . . . . . 21Managing Controlled Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Managing Data Standard Compliance Checks . . . . . . . . . . . . . . . . . . . . . . . . . 29Analyzing Domain Use and Promoting a Custom

    Domain to Be a Template . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

    Chapter 3 / Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Overview: Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Run and Save a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

    PART 3 Information for Trial Managers 49

    Chapter 4 / Studies and Submissions Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

  • Overview: Studies and Submissions Management . . . . . . . . . . . . . . . . . . . . 52Working with Folder Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Working with Library Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58Creating a Study or Submission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Managing Studies and Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70Monitoring the Statuses of Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Comparing the Metadata of a Standard Domain to Its Template . . . . 78

    PART 4 Information for Clinical Programmers or Data Managers 81

    Chapter 5 / SDTM Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Types of Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Creating a Domain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Domain Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94Importing CRT-DDS Domain Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98Loading Data into Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Assessing CDISC SDTM Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

    Chapter 6 / ADaM Data Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109Types of ADaM Data Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110Special Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111Creating an ADaM Data Set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Promoting an ADaM Data Set to Be a User-Defined Template . . . . . 122Create an ADaM Data Set from a User-Defined Analysis Data Set 124Assessing ADaM Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126

    Chapter 7 / Creating a define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131Transforming SDTM Domains or ADaM Data Sets

    into a define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132Adding Information to the CRT-DDS define.xml File . . . . . . . . . . . . . . . . . 137Creating the Define.xml file from Customized Data . . . . . . . . . . . . . . . . . . 144Validating a CRT-DDS define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

    iv Contents

  • PART 5 SAS Integration Adapter for Medidata Rave 149

    Chapter 8 / General Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Define a Medidata Rave Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151Enable a SAS Clinical Data Integration User to Log

    In to Medidata Rave . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152Verify That the Medidata Rave Server Has Been

    Registered Properly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

    Chapter 9 / Study Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155Manage the Connection between a SAS Clinical

    Data Integration Study and a Medidata Rave Study . . . . . . . . . . . . . . . 156Create a SAS Clinical Data Integration Data Table

    Definition from Medidata Rave Metadata . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160Manage the Medidata Rave Properties of a SAS

    Clinical Data Integration Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163Managing the Codelist Table in a SAS Clinical Data

    Integration Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 168Review the Medidata Rave Properties of a SAS

    Clinical Data Integration Data Table Definition . . . . . . . . . . . . . . . . . . . . . . 172Retrieving Medidata Rave Study Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173Schedule a Job to Update Study Data from Medidata Rave . . . . . . . . 178

    PART 6 Appendixes 179

    Appendix 1 / Addition of Users to the Clinical Administrator Group . . . . . . . . . . . . . 181

    Appendix 2 / Repair of Clinical Objects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

    Appendix 3 / SAS Clinical Data Integration Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 189

    Contents v

  • Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

    vi Contents

  • Part 1

    Introduction

    Chapter 1Overview: SAS Clinical Data Integration . . . . . . . .

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