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

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Transcription:

1. E2B Writer...4 1.1....4 E2B Writer... 4... 4 1.2...5 PCAT... 5... 5... 5 1.3 CD...5 2. E2B Writer...6 2.1....6 2.2....8 2.3. sp1_3_4...10 2.4. MedDRA MedDRA CD-ROM...11 3. E2B Writer...12 3.1....12... 12... 13... 14... 14 3.2....15... 15... 15... 15... 15... 15... 16...16 4. E2B Writer...17 4.1....17... 17... 18 4.2....19... 19... 20... 21... 22 4.3....23 4.4....26 A2... 26 B.2... 27 B.3... 28 4.5. MedDRA...31 5....32 5.1. J ICSR...32 2

5.2. SP...33 6....35 6.1. A.3.1 A.3.2...35 6.2....36 7....39 7.1....39 7.2....40 8. ZIP...41 8.1.SGML...41 8.2. ZIP...42 9....43 10. Ack...44 11....45 12....47 13. SGML...51 14....52 15....55 15.1....55 15.2. MedDRA...57... 57... 57... 57 LLT... 58 15.3. MedDRA...58... 58... 58 LLT... 59 15.4....59... 59... 59... 59 3

4 E2B Writer E2B/M2 E2B Writer MedDRA

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

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

4. E2B Writer 5. 7

E2B Writer Updata setup E2B Writer 8

E2B Writer 9

SP C CD-ROM sp1_3_4 C sp1_3_4 C 10

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

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

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

14 Next 1= Next 2=

15 E2B Writer E2B Writer

B.3.1 16

17 Ack E2B Ack =00001 = = =JP= OK 1) SGML 2 20031107ABC001

OK E2B E2B E2B E2B Writer E2B E2B E2B Writer A.1.13 A.1.13.1 18

19

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

22 P.15 UPDOWN

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 2

J ICSR P.32 25

26 A2 1

B2 1 1 1 B.4 1 27

28 B.3 Excel B.3

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

30

MedDRA MedDRA MedDRA MedDRA MedDRA CD Web OK 31

J ICSR J ICSR J ICSR 32

SGML SGML sp1_3_4 SP sp1_3_4 sp1_3_4 bin nsgmls.exe 33

34

A.3.1 A.1.10.2 A.1.10.2 J.1 A.1.0.1 35

J ICSR 36

37

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

E2B OK E2B Writer 39

E2B Writer E2B SGML ZIP Excel Ack SGMLZIPExcelE2BAck SGMLZIPExcelE2BAck 40

SGML SGML OK OK SGML SGML J ICSR 41

ZIP zip J ICSR SGML J ICSR SGML OK 42

E2B Writer A.1.13 A.1.13.1 43

Ack (Ack) 44

Excel 45

46 B.2B.3B.4

Excel Excel 1 Microsoft Excel2000 47

1024 1 2 48

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

30 50

SGML J SGML [J.4a] 51

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

MedDRA_V 53

54

E2B Writer E2B Writer DTD J ICSR M 1.M.2 A A.1 A A.1 1.A.1.13 A.1.13.1 A.1.14 A.1.11.0 A.1.9 A.1.10.1 A.1.10.2 A.1.11 A.1.13 A.1.13.1 A.1.14 A.1.11.0 A.1.11.1 A.1.11.2 A.1.12.0 A.1.12 A A.2 A A.3.1 A A.3.2 B B.1 1.B.1.7.2 B.1.7.1 2.B.3.2 B.1.7.2 1.2. B.1.7.2 B.3.2 B.1.7 B.1.7.1a.1 MedDRA 3.B.1.9.3 B.1.9.2 4.B.1.10.7.2 B.1.10.7.1a.1 55

B B.2 B B.3.1 1.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.17.1 1.2. 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

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

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

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

MedDRA MedDRA MedDRA MedDRA MedDRA 60

1130033 1813 TEL03-3813-5471 FAX03-3813-5475 E2B/M2 E2B Writer Version1.4 2004 12 10 JT 61