1. E2B Writer E2B Writer PCAT CD E2B Writer sp1_3_ MedD

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2 1. E2B Writer E2B Writer PCAT CD E2B Writer sp1_3_ MedDRA MedDRA CD-ROM E2B Writer E2B Writer A B B MedDRA J ICSR

3 5.2. SP A.3.1 A ZIP SGML ZIP Ack SGML MedDRA LLT MedDRA LLT

4 4 E2B Writer E2B/M2 E2B Writer MedDRA

5 CPUPentium450MH 256MB OSWindows 98SEMe2000XP MicrosoftExcel 2000Office 2000 Microsoft Excel Windows 98SEWindows 2000Windows XP Excel 2000Office2000 Microsoft 1. Full_Setup setup.exe 2. Updata setup.exe 3. sp1_3_4 C 4..pdf 5..pdf manual 6..pdf 3 3 5

6 E2B Writer 1. Full_Setup setup.exe 2. E2B Writer 3. OK E2B Writer 6

7 4. E2B Writer 5. 7

8 E2B Writer Updata setup E2B Writer 8

9 E2B Writer 9

10 SP C CD-ROM sp1_3_4 C sp1_3_4 C 10

11 MedDRA MedDRA CD-ROM 1. MedDRACD-ROM CD-ROM 2. E2B WriterImportMedDRA 3. MedDRACD-ROM ASC 4. ASC Mdra_ OK MedDRA OK MedDRA CD-ROM 11

12 E2B Writer E2B Writer E2B Writer DTD J SGML SGMLZIP E2B DTD OK Next 12

13 J SGML SGMLZIP EXCEL J ICSR ICSR SGML SGML ZIP Excel E2B OK C C OK 13

14 14 Next 1= Next 2=

15 15 E2B Writer E2B Writer

16 B

17 17 Ack E2B Ack =00001 = = =JP= OK 1) SGML ABC001

18 OK E2B E2B E2B E2B Writer E2B E2B E2B Writer A.1.13 A

19 19

20 SGML I E2B E C SGML J Ctrl+J Zip Z SGML.E2B Ack SGML J ICSR SGML Zip Ack HTML B MedDRA T E S J SGML SGML R K ~ ~ M Excel C Excel N Ctrl+N H Ctrl+H E2B Writer.E2B.E2B S C X E2B Writer 20

21 21

22 22 P.15 UPDOWN

23 ControlandC ControlandV.J ICSR M.1A.1A.2A.3.1A.3.2B.1B.2B.3.1B.4B.5 J J ICSR J ICSR ICS J. ~ ~.. 23

24 24 2

25 J ICSR P.32 25

26 26 A2 1

27 B B

28 28 B.3 Excel B.3

29 hdhidejima = ( ) hd hidejima hidejima hidejima B.3 29

30 30

31 MedDRA MedDRA MedDRA MedDRA MedDRA CD Web OK 31

32 J ICSR J ICSR J ICSR 32

33 SGML SGML sp1_3_4 SP sp1_3_4 sp1_3_4 bin nsgmls.exe 33

34 34

35 A.3.1 A A J.1 A

36 J ICSR 36

37 37

38 B.2B.3B.4 Excel Excel 38

39 E2B OK E2B Writer 39

40 E2B Writer E2B SGML ZIP Excel Ack SGMLZIPExcelE2BAck SGMLZIPExcelE2BAck 40

41 SGML SGML OK OK SGML SGML J ICSR 41

42 ZIP zip J ICSR SGML J ICSR SGML OK 42

43 E2B Writer A.1.13 A

44 Ack (Ack) 44

45 Excel 45

46 46 B.2B.3B.4

47 Excel Excel 1 Microsoft Excel

48

49 ZIP ZIP ZIP ZIP ZIP SGML ZIP _ 1 SGML ZIP ZIP 49

50 30 50

51 SGML J SGML [J.4a] 51

52 2Writer.E2B> SGML.E2B No. E2B Writer No. No. 1 A.1.6b MedDRA Ver. SGML 52

53 MedDRA_V 53

54 54

55 E2B Writer E2B Writer DTD J ICSR M 1.M.2 A A.1 A A.1 1.A.1.13 A A.1.14 A A.1.9 A A A.1.11 A.1.13 A A.1.14 A A A A A.1.12 A A.2 A A.3.1 A A.3.2 B B.1 1.B B B.3.2 B B B.3.2 B.1.7 B.1.7.1a.1 MedDRA 3.B B B B a.1 55

56 B B.2 B B B.3.2 B.1 B B.4 1.B.4.k.2.2 B.4.k.19 2.B.4.k.19 B.4.k B.4.k.17.1 B.4.k.19 B.4.k.2 B.4.k.2.2 B.4.k.2.2 B.4.k.2.2 B.4.k.17.2 B.4.k.17.2a MedDRA B.4.k.17.2b B.4.k.17.1 B.4.k.18 B.4.k.18.1a MedDRA B.4.k.18.1b B.4.k.18.2 B.4.k.18.3 B.4.k.18.4 B B.5 56

57 E2B Writer MedDRA MedDRA MedDRA MedDRA MedDRA MedDRA head MedDRA head 57

58 E2B Writer MedDRA LLT PT LLT / MedDRA / MedDRA LLT PT PT Y OK LLT PT PT MedDRA LLT B.2.i.1b PT B.2.i.2b MedDRA LLT 58

59 LLT PT LLT PT MedDRA PT PT MedDRA LLT PT LLT E2B Writer 59

60 MedDRA MedDRA MedDRA MedDRA MedDRA 60

61 TEL FAX E2B/M2 E2B Writer Version JT 61

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