User manual SAS CLINICAL DATA STANDARDS TOOLKIT 1.3 INSTALLATION QUALIFICATION

[. . . ] SAS Clinical Data Standards Toolkit 1. 3 Installation Qualification ® The correct bibliographic citation for this manual is as follows: SAS Institute Inc. SAS ® Clinical Data Standards Toolkit 1. 3: Installation Qualification. SAS® Clinical Data Standards Toolkit 1. 3: Installation Qualification Copyright © 2010, SAS Institute Inc. , Cary, NC, USA All rights reserved. For a hard-copy book: No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without the prior written permission of the publisher, SAS Institute Inc. [. . . ] The data set dm should have 70 records and 20 columns. 5 Review the folder CST_SDTM_312/derived/data. 6 End the current SAS session. Sign-off Test 6 ­ SDTM 3. 1. 2 Build Source Data Signature Date Test Was Executed Did the test pass?(Yes or No) Comments Test 6 ­ SDTM 3. 1. 2 Build Source Metadata This test references derived data from a CRT-DDS (define. xml) file to build a set of SDTM 3. 1. 2 metadata in a structure required by SAS Clinical Standards Toolkit. Steps 1 2 Start a new SAS session. In the SAS Program Editor, select File->Open and select CST_SDTM_312/programs/create_sourcemetadata. sas. This code outputs to the SAS log and creates data sets in both the results and derived/metadata subfolders under CST_SDTM_312. As in Test 5, the library information was cleaned up by the program, so these files are not immediately accessible under Libraries in the SAS Explorer. In Windows, you can access these files through the SAS Explorer by navigating from within the SAS Explorer starting at the node labeled "My Computer. " On UNIX, it is necessary for you to copy these data sets into a folder that is viewable by the SAS Explorer. Installation Qualification / / Test 7 ­ SDTM 3. 1. 2 Build SAS Formats 9 3 4 Review the log to see whether there are any errors or warnings. Review the data set named srcmeta_results under CST_SDTM_312/results. For the records where the column labeled "validation check identifier" (named checkid) is blank, examine the message column and check for correct paths and process metadata. The column labeled "process status" (named _cst_rc) should be 0 for all records. The last three records should report that study reference data was created in folder CST_SDTM_312/derived/metadata. There should be three new data sets: source_columns, source_study, source_tables. The data set named source_tables should have 33 records. 5 Review the folder CST_SDTM_312/derived/metadata. 6 End the SAS session. Sign-off Test 3 ­ SDTM 3. 1. 1 Build Source Metadata Signature Date Test Was Executed Did the test pass?(Yes or No) Comments Test 7 ­ SDTM 3. 1. 2 Build SAS Formats This test referenced derived data from a CRT-DDS (define. xml) file to build a SAS format catalog that represents the codelists in the CRT-DDS file. Steps 1 2 Start a new SAS session. In the SAS Program Editor, select File->Open and select CST_SDTM_312/programs/create_formatsfromcrtdds. sas. The code outputs to the SAS log and creates a data set named codelist_results in CST_SDTM_312/results and creates a catalog named cterms under CST_SDTM_312/derived/formats. As in Tests 5 and 6, the library information was cleaned up by the program so these files are not immediately accessible under Libraries in the SAS Explorer. In Windows, you can access these files through the SAS Explorer by navigating from within the SAS Explorer starting at the node labeled "My Computer. " On UNIX, it is necessary for you to copy these data sets into a folder that is viewable by the SAS Explorer. Review the data set named codelist_results under CST_SDTM_312/results. 3 4 10 Test 8 ­ SDTM 3. 1. 2 Report Check Metadata Chapter 1 For the records where the column labeled "validation check identifier" (named checkid) is blank, examine the message column and check for correct paths and process metadata. The column labeled "process status" (named _cst_rc) should be 0 for all records and there should not be any checks with result severity='Warning: Check not run'. The last record should report "Process completed successfully. " 5 6 Folder CST_SDTM_312/derived/formats should contain a catalog cterms (named cterms. sas7bcat). End the current SAS session. Sign-off Test 7 ­ SDTM 3. 1. 2 Build SAS Formats Signature Date Test Was Executed Did the test pass?(Yes or No) Comments Test 8 ­ SDTM 3. 1. 2 Report Check Metadata This test verifies that all metadata about SDTM 3. 1. 2 validation checks has been properly installed. A sample report itemizes this metadata. Steps 1 2 Start a new SAS session. [. . . ] You might see one warning that states, "The JAVAOBJ is an experimental feature in this release and is not intended for use in the development of production applications. " 14 Test 12 ­ Controlled Terminology 200810 Chapter 1 4 Review the data set read_results under CST_ODM/results. In the SAS Explorer, you can also view it as Read_results in the Results library. Examine the message column to verify correct paths and process metadata. The column labeled Process status (named _cst_rc) should be 0 for all records. The last record should report that the ODM file was read successfully. 5 The folder CST_ODM/metadata should contain two data sets: source_tables and source_columns. [. . . ]