Yousuke Tamura Programmer Clinical Science Dep., R&D AstraZeneca K.K. 2005/11/30 1

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1 - Word SAS - Yousuke Tamura Programmer Clinical Science Dep., R&D AstraZeneca K.K. 2005/11/30 1

2 Contents Background Previous method Change/Shift/Transition Current method Benefit of current method Application of the method Future plan Summary 2005/11/30 2

3 Background 成果物 / 役割 Clinical Study Report (CSR) Author:Medical Writer(MW) Source for CSR by Statistician Statistical Analysis Plan (SAP) Statistical Analysis Report (SAR) Programmer Table/Listing/Figure 2005/11/30 3

4 Background 要求事項 Programmer Clinical Study Report (CSR) Table/Listing/Figure Word Format Table/Listing Word 2005/11/30 4

5 Background SAS output / Word 2005/11/30 5

6 Previous method Table/Listing SUGI-J 96 Tabulate ( ) DDE SAS Macro Excel Macro Tabulate Excel Word Figure.cgm Word Import Macro) (Manual/Word 2005/11/30 6

7 Previous method 課題 / 問題 Tabulate Maintainability Manual QC Manual Programmer Medical Writer(MW) 2005/11/30 7

8 Change/Shift/Transition 1.SOP Clinical Study Report (CSR) Lead Author: Medical communication scientist(mcs) Co-Author Statistician Statistical Analysis Plan (SAP) Programmer Table/Listing/Figure 2005/11/30 8

9 Change/Shift/Transition 2.Word StudyCode:XXXXXXXXX XXXXXXXXX XXXXXXX XXXXX XXXXX XXXXXXX TOTAL JAPANESE XXXXXXXXXXXXXX xxx.x xxx.x xxx.x xxx.x OTHER xxx.x xxx.x xxx.x TOTAL xxx.x xxx.x xxx.x xxx.x NON-JAPANESE XXXXXXXXXXXXXX xxx.x xxx.x xxx.x xxx.x OTHER xxx.x xxx.x xxx.x xxx.x TOTAL xxx.x xxx.x xxx.x xxx.x xxx.x 2005/11/30 9

10 Change/Shift/Transition 要求事項 1.Programmer Clinical Study Report (CSR) Appendix Author 2.Programmer Clinical Study Report (CSR) Table/Listing/Figure Word Format Table/Listing Word Template 2005/11/30 10

11 Current method To_WORD SAS Style Word SAS Macro x VBS (Visual Basic Script) Word Template & Word Macro 概要 SAS ODS html SAS VBS VBS SAS VBS Word Macro Word Macro html Import Style 2005/11/30 11

12 Current method 2005/11/30 12

13 Current method SAS Macro:ToWord01_Start ODS(html) Template SAS Program Output (html)(proc Report/Freq etc.) SAS Macro:ToWord01_End VBS VBS VBS Word Macro Word Macro html Import Style 2005/11/30 13

14 Current method SAS Program %ToWord01_Start Proc Report /Freq etc. %ToWord01_End Output (html) VBS Word Template Word Macro 2005/11/30 14

15 Current method SAS Program %ToWord01_Start Proc Report /Freq etc. %ToWord01_End VBS Output (html) VBS Word Macro Word Template Word Macro Style 2005/11/30 15

16 Current method Sample : Disposition of enrolled subjects Category N (%) Enrolled XXX (XXX.X) Randomized XXX (XX.X) Screening failures XXX (XX.X) Reason for screening failure * Eligibility Criteria not Fulfilled XXX (XX.X) Adverse Event XXX (X.X) Development of Study-Specific Discontinuation Criteria XXX (X.X) Subject not Willing to Continue Study XXX (X.X) Subject Lost to Follow-up XXX Other XXX (X.X) * The denominator of a percentage is the number of all non-randomized subjects. 2005/11/30 16

17 Current method Sample2 Table xx.x.x.x.x.x Summary of haematology - Erythrocyte, Volume Fraction (%) [xx - xx] Observed values Change from baseline (Pre-dose) Cohort Treatment Protocol time N Mean SD Min Median Max N Mean SD Min Median Max Placebo* Pre-entry x xx.xx x.xx xx.x xx.xx xx.x Pre-dose xx xx.xx x.xx xx.x xx.xx xx.x xx:xxa xx xx.xx x.xx xx.x xx.xx xx.x xx -x.xx x.xx -x.x -x.xx x.x xx:xxb xx xx.xx x.xx xx.x xx.xx xx.x xx -x.xx x.xx -x.x -x.xx x.x A XXXxxxx 30mg Pre-entry x xx.xx x.xx xx xx.xx xx.x Pre-dose x xx.xx x.xx xx.x xx.xx xx xx:xxa x xx.xx x.xx xx xx.xx xx.x x x.xx x.xx -x.x x.xx x.x xx:xxb x xx.xx x.xx xx.x xx.xx xx.x x -x.xx x.xx -x.x -x.xx x.x XXXxxxx 200mg Pre-dose x xx.xx x.xx xx xx.xx xx.x xx:xxa x xx.xx x.xx xx.x xx.xx xx.x x x.xx x.xx -x.x x.xx x.x xx:xxb x xx.xx x.xx xx.x xx.xx xx.x x x.xx x.xx -x.x -x.xx x.x B XXXxxxx 60mg Pre-entry x xx.xx x.xx xx.x xx.xx xx.x Pre-dose x xx.xx x.xx xx.x xx.xx xx.x xx:xxa x xx.xx x.xx xx.x xx.xx xx.x x x.xx x.xx -x.x x.xx x.x xx:xxb x xx.xx x.xx xx xx.xx xx.x x -x.xx x.xx -x -x.xx x XXXxxxx xxxmgd Pre-dose x xx.xx x.xx xx.x xx.xx xx.x xx:xxa x xx.xx x.xx xx.x xx.xx xx.x x -x.xx x.xx -x.x -x.xx x.x xx:xxb x xx.xx x.xx xx.x xx.xx xx.x x -x.xx x.xx -x -x.xx x.x * N represents the number of observations, not the number of subjects. 2005/11/30 17

18 Benefit of current method 課題 / 問題の比較 Programmer MCS 2005/11/30 18

19 Benefit of current method Role 別の利点 Programmer Procedure TABULATE Medical communication scientist(mcs) Template Manual All Team member Manual CSR QC 2005/11/30 19

20 Application of the method 1.Figure Figure.cgm Word Import (Manual/Word Macro) To_Word VBS Word Macro SAS VBS Word template Requirement Word Macro GlueFileGlueFile Word Import GlueFile+VBS 2005/11/30 20

21 Application of the method 1.Figure Figure SampleFigure Lead:Sample b 7 test C=a a Subject b 7 test C=b b 7 test C=c b 7 test C=d a a a Subject Subject Subject This is a sample. Please try to use this macro and give me your comments 2005/11/30 21

22 Application of the method 2.Compare Tables/Listings Table/Listing Double Programming QC QC Dataset Compare Text Compare To_Word html Word CompareFiles 2005/11/30 22

23 Application of the method 2.Compare Tables/Listings \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ \ 2005/11/30 23

24 Future Plan 課題 / 問題 2005/11/30 24

25 Future Plan SAS Compare Tool Tool Control Validation Report Programmer Clinical Study Report (CSR) Appendix Author Author CSR Appendix Appendix Control 2005/11/30 25

26 OLE/DDE VBS SAS Style Word html Table/Listing QC Template Manual CSR QC 2005/11/30 26

27 end 2005/11/30 27

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