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  • SASClinical Data Integration 2.3Users GuideSecond Edition

    SAS Documentation

  • The correct bibliographic citation for this manual is as follows: SAS Institute Inc., 2012. SAS Clinical Data Integration 2.3: Users Guide, Second Edition. Cary, NC: SAS Institute Inc.

    SAS Clinical Data Integration 2.3: Users Guide, Second Edition

    Copyright 2012, SAS Institute Inc., Cary, NC, USA

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

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

    Electronic book 1, April 2012

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  • Contents

    PART 1 Introduction 1

    Chapter 1 Overview of SAS Clinical Data Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3What is SAS Clinical Data Integration? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Typical Workflow in SAS Clinical Data Integration . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Recommended Reading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

    PART 2 Information for Clinical Administrators 7

    Chapter 2 Administering Data Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9About Data Standards Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Importing Data Standards Metadata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Customizing Data Standard Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14Customizing Data Standard Domain Templates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Managing Controlled Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16Managing Data Standard Compliance Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Analyzing Domain Use and Promoting a Custom Domain . . . . . . . . . . . . . . . . . . . . . . 29

    Chapter 3 Working with Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33About Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Run and Save a Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

    PART 3 Information for Trial Managers 35

    Chapter 4 Managing Studies and Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37About Managing Studies and Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37Working with Default Folders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Working with Default Libraries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40Creating a Study or Submission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Manage Studies and Submissions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45Monitoring the Statuses of Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Comparing the Metadata of a Standard Domain to Its Template . . . . . . . . . . . . . . . . . . 48

    PART 4 Information for Clinical Programmers or Data Managers 51

    Chapter 5 Working with Domain Data and Metadata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Creating a Domain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Edit Domain Properties . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60Add Domain Columns or Edit Domain Columns Properties . . . . . . . . . . . . . . . . . . . . . 61Loading Data into Domains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63Assessing CDISC SDTM Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

  • Transforming SDTM Domains in a define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Adding Information to the CRT-DDS define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . 69Running the CDISC-SDTM to CRT-DDS Transformation on Saved Data . . . . . . . . . . 75Validating a CRT-DDS define.xml File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77Reporting on the Results of a Transformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Generating Unique Sequence Numbers as an Identifier Variable . . . . . . . . . . . . . . . . . 80

    PART 5 SAS Integration Adapter for Medidata Rave 83

    Chapter 6 General Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Define a Medidata Rave Server . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85Enable a SAS Clinical Data Integration User to Log In to Medidata Rave . . . . . . . . . . 85Verify That the Medidata Rave Server Has Been Registered Properly . . . . . . . . . . . . . 86

    Chapter 7 Study Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Manage the Connection between a SAS Clinical Data Integration

    Study and a Medidata Rave Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88Create a SAS Clinical Data Integration Data Table Definition

    from Medidata Rave Metadata . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90Manage the Medidata Rave Properties of a SAS Clinical Data Integration Study . . . . 92Managing the Codelist Table in a SAS Clinical Data Integration Study . . . . . . . . . . . . 96Review the Medidata Rave Properties of a SAS Clinical Data

    Integration Data Table Definition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Retrieving Medidata Rave Study Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99Schedule a Job to Update Study Data from Medidata Rave . . . . . . . . . . . . . . . . . . . . . 103

    PART 6 Appendixes 105

    Appendix 1 Adding Users to the Clinical Administrator Group . . . . . . . . . . . . . . . . . . . . . . . 107

    Appendix 2 Repairing Clinical Objects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

    Appendix 3 SAS Clinical Data Integration Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

    Appendix 4 Publish to SAS Drug Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113Overview of Publish to SAS Drug Development Feature . . . . . . . . . . . . . . . . . . . . . . 114Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Installation and Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114General Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116SAS Drug Development Servers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Jobs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117Transformations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118Process Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119Paths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120Input and Output Folders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122WebDAV Options . . . .

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