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1 KAIZEN 24 3 DM

2 KAIZEN KAIZEN KAIZEN KAIZEN TQM (Total Quality Management) ECRS KAIZEN KAIZEN CRF Annotated CRF LPO DBL CRF

..18 4.1...18 4.2...18 4.3...19 4.3.1...19 4.3.2...21 4.3.2.1...21 4.3.2.2 CRF...22 4.3.2.3 Annotated CRF.

3 SAE Reconciliation A...37 B...43

4 Annotated CRF acrf CDISC CRF CSP CSR DB DBL DMP FAS FPI FTE IRB LPO SAE SAP SDV TQM Annotated Case Report Form Clinical Data Interchange Standards Consortium Case Report Form Clinical Study Protocol Clinical Study Report Database Database Lock Data Management Plan Full Analysis Set First Patient In Full Time Equivalent Institutional Review Board Last Patient Out Serious Adverse Event Statistical Analysis Plan Source Data Verification Source Document Verification Total Quality Management

Lock Data Management Plan Full Analysis Set First Patient In Full Time Equivalent Institutional Review Board Last Patient

5 1 TQM Total Quality Management * 1 TQM DM DM * DIA Annual Meeting Eli Lilly Lean Six Sigma DIA Lean Six Sigma 1

6 2 KAIZEN 2.1 KAIZEN KAIZEN KAIZEN CSP DBCSR 7 * 2 KAIZEN * 2 P., T. ( ) ( ) 2003 BP. 2

7 * KAIZEN KAIZEN KAIZEN 2.3 KAIZEN KAIZEN Lean Production System * 4 * 3 PDCA Plan Do Check Act * 4 P., T. ( ) ( ) 2003 BP. 3

8 2.3.2 TQM (Total Quality Management) TQM TQM ECRS ECRS ECRS *5 * 6, 7 6 * * * 7 DM

9 ECRS Eliminate Combine Rearrange Simplify 5W1H ( liminate) ( ombine) ( earrange) ( implify) ECRS Eliminate Eliminate Combine Rearrange 5

10 Simplify 2.4 KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN *8 * 8 KAIZEN * 9 Last Patient Out 6

11 * KAIZEN KAIZEN * 11 KAIZEN KAIZEN KAIZEN * 12 KAIZEN * 13 KAIZEN KAIZEN KAIZEN * 14 KAIZEN KAIZEN KAIZEN * Clinical Research Professionals No * 11 P., T. ( ) ( ) * 12 BP * 13 Lean Six Sigma * 14 KAIZEN Six Sigma TQM 7

KAIZEN KAIZEN KAIZEN * 14 KAIZEN KAIZEN KAIZEN *10 21 1

12 DBL Last Patient Out LPO CSR 2 DM 21 6 * 15 First Patient In 8

13 * * CRF 9

14 1 10

15 2 11

16 Full Time Equivalent FTE 1 2 FTE FTE B 12

17 3 CSP DB 4 CRF 13

18 5 DMP 6 DB 14

19 7 LPO DBL 8 LPO CRF 15

20 9 LPO CRF FTE FTE Full Time Equivalent FTE /8 FTE FTE OECD Frascati Manual 1964 FTE 2 FTE OECD 16

21 FTE DM DM FTE 17

22 ECRS ECRS ECRS Eliminate 13 Combine 10 Rearrange 12 Simplify Eliminate IRB DM CRF Combine CRF CRF Rearrange CRF Simplify CRF DMP DB 18

23 CRF CRF DB FTE 19

24 R, E,C,R,S, E,C,S, E,C,R,S, E,C,R,S, S, S, 10 20

25 DM DB A B A 7 B 8 A B 15 DM CDISC

26 CRF CSP CRF CRF CRF DB CSP CSP CRF CRF CRF CSP CRF DB CRF CSP DM CRF CSP CRF DB DB CSP EDC FPI ecrf EDC ecrf CSP CSP EDC CRF IRB IRB CRF CRF IRB IRB CSP CRF IRB CSP 1 CRF CRF 22

27 CSP CSP CRF CSP CRF CRF CSP CRF IRB IRB CSP CRF CRF CSP CRF CSP CRF CRF CRF IRB CRF IRB IRB IRB GCP IRB CSP Annotated CRF Annotated CRF DB Annotated CRF DB CRF DB Annotated CRF Annotated CRF CRF 23

28 DB 24

29 11 25

30 4.4 LPO DBL LPO DBL 12 CRF MedDRA CRF DBL LPO CRF 29.1 LPO CRF

31 E,C,R,S, E,C,R,S C,R,S E,R,S C,R E,C,R,S 12 27

32 CRF LPO CRF SDV DBL CRF SDV CRF LPO DBL CRF SDV LPO DBL DM CRF CRF CRF CRF EDC EDC CRF DBL CRF 1 28

33 CSP CRF CSP CRF LPO DBL CSP CSP ICH-E9 Q Q9. ( ) CRF KOL DBL EDC EDC 29

34 50 75% Living Document CSP CSP CSP CRF DM SDV DM CRF DM DM 100 EDC ecrf 30

35 CRF CRF CRF DBL LPO DBL LPO DBL CSP CRF CRF DBL DBL LPO CRF DBL CRF LPO DBL 1 31

36 DBL CRF CRF CRF DB Data Clarification Form CRF DM SAE Reconciliation CRF LPO SAE Reconciliation 3 LPO 3 LPO % LPO LPO LPO CRF LPO LPO DBL 32

37 13 33

38 * FTE (B) FTE (A)-(B) 4 (B) (A)-(B) *

39 4.6 ECRS PDCA 2009 EDC CRF CRF EDC EDC CRF EDC EDC 35

40 5 KAIZEN KAIZEN KAIZEN IT EDC TQM KAIZEN 36

41 A 1 Annotated CRF acrf acrf Annotated Case Report Form CRF 2 CDISC CDISC Clinical Data Interchange Standards Consortium CDISC CDISC CDISC 3 CRF CRF Case Report Form CRF CRF Visit Book Visit Book Book 4 CRF CRF 37

42 CRF 5 CRF CRF CRF 6 CSP Clinical Study Protocol CSP 7 CSP CSP 8 CSR CSR Clinical Study Report 9 DB Database DB 10 DB DB DB DB DB DB DB 12 DB 13 DMP DMP Data Management Plan DM 14 FAS FAS Full Analysis Set Intention-to-treat 15 FPI FPI First Patient In 38

43 FPFV First Patient First Visit FSI First Subject In FSFV(First Subject First Visit) 16 IRB Institutional Review Board IRB 17 LPO LPO Last Patient Out LPLV Last Patient Last Visit LSO Last Subject Out LSLV(Last Subject Last Visit) 18 PPS PPS Per Protocol Set (Valid Cases, Efficacy Sample, Evaluable Subjects Sample) 19 SAE SAE Serious Adverse Event 20 SAE Reconciliation 21 SAP SAE SAE SAE SAE SAE SAP Statistical Analysis Plan 39

44 22 SDV SDV Source Data Verification Source Document Verification 23 CRF CRF CLF(Correction Log Form) DCF Data Clarification Form Data Correction Form 26 CRF CRF 27 ICD-9 MEDIS MedDRA MedDRA J-ART COSTART WHO-ART WHO-Drug-Dictionary 28 FAS PPS CRF 31 DBL DBL Database Lock 32 40

45 DB URS DB UAT URS UAT 35 CRF CRF CDASH 36 DB SDTM CRF 41 Blind Review 42 CRF 41

46 CRF 42

47 B 23 B- 1 CSP DB B- 2 CRF 43

48 B- 3 DMP B- 4 CRF 44

49 B- 5 DB B- 6 Annotated CRF 45

50 B- 7 DB B- 8 46

51 B- 9 B

52 B

53 B- 12 LPO DBL B- 13 LPO CRF 49

54 B- 14 LPO CRF B

55 B- 16 DB 51

56 KAIZEN RI DM

技術流出防止指針公表用.PDF

技術流出防止指針公表用.PDF 15 3 1 4 .. 2 2.. 4. 6.10 10.14.16.19.24.26.28 1 2 1 2002 7 3 2002 3 4 2 3 5 4 4 6 7 8 5 5 9 plan (do) (check) (act) 1) 2) 3) 4) 5) 6) 7) 10 11 12 13 14 15 16 17 18 6 6 19 / / 20 21 22 7 23 8 24 25 26