KAIZEN 24 3 DM
1...1 2 KAIZEN...2 2.1 KAIZEN...2 2.2 KAIZEN...3 2.3 KAIZEN...3 2.3.1...3 2.3.2 TQM (Total Quality Management)...4 2.3.3 ECRS...4 2.4 KAIZEN...6 2.5 KAIZEN...7 3...8 3.1...8 3.2...9 3.2.1...9 3.2.2...12 3.3...17 3.4...17 4...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...23 4.3.3...24 4.4 LPO DBL...26 4.4.1...26 4.4.2...28 4.4.2.1 CRF...28 4.4.2.2...28 4.4.2.3...30 4.4.2.4...31
4.4.2.5...31 4.4.2.6 SAE Reconciliation.32 4.4.3...32 4.5...34 4.6...35 5...36 A...37 B...43
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
1 TQM Total Quality Management * 1 TQM DM DM * 1 2007 DIA Annual Meeting Eli Lilly Lean Six Sigma 2010 2011 2 DIA Lean Six Sigma 1
2 KAIZEN 2.1 KAIZEN KAIZEN KAIZEN CSP DBCSR 7 * 2 KAIZEN * 2 P., T. ( ) ( ) 2003 BP. 2
* 3 2.2 KAIZEN KAIZEN KAIZEN 2.3 KAIZEN KAIZEN 3 2.3.1 Lean Production System * 4 * 3 PDCA Plan Do Check Act * 4 P., T. ( ) ( ) 2003 BP. 3
2.3.2 TQM (Total Quality Management) TQM TQM 2.3.3 ECRS ECRS ECRS *5 * 6, 7 6 * 5 2004. * 6 1999 * 7 DM 2009 4
6 100 3.4 100 3.4 ECRS Eliminate Combine Rearrange Simplify 5W1H ( liminate) ( ombine) ( earrange) ( implify) ECRS Eliminate Eliminate Combine Rearrange 5
Simplify 2.4 KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN KAIZEN *8 * 8 KAIZEN * 9 Last Patient Out 6
*10 2.5 KAIZEN KAIZEN * 11 KAIZEN KAIZEN KAIZEN * 12 KAIZEN * 13 KAIZEN KAIZEN KAIZEN * 14 KAIZEN KAIZEN KAIZEN *10 21 1 Clinical Research Professionals. 2010. No.19. 2-7. * 11 P., T. ( ) ( ) 2003. * 12 BP * 13 Lean Six Sigma * 14 KAIZEN Six Sigma TQM 7
3 3.1 5 15 DBL Last Patient Out LPO CSR 2 DM 21 6 * 15 First Patient In 8
3.2 3.2.1 23 * 16 1 2 * 16 100 CRF 9
1 10
2 11
3.2.2 23 Full Time Equivalent FTE 1 2 FTE 8 1 1 FTE 2 3 9 B 12
3 CSP DB 4 CRF 13
5 DMP 6 DB 14
7 LPO DBL 8 LPO CRF 15
9 LPO CRF FTE FTE Full Time Equivalent 2 1 8 4 1 4 6 2 4 FTE 4 2 4 4/8 FTE FTE OECD Frascati Manual 1964 FTE 2 FTE OECD 16
FTE 2002 555-558. 3.3 DM DM 3.4 23 FTE 17
4 4.1 2 ECRS ECRS 4.2 41 ECRS Eliminate 13 Combine 10 Rearrange 12 Simplify 17 12 Eliminate IRB DM CRF Combine CRF CRF Rearrange CRF Simplify CRF DMP DB 18
4.3 4.3.1 10 3.1 CRF CRF DB FTE 19
4.3.2.1 R, E,C,R,S, 4.3.2.2 E,C,S, 4.3.2.1 4.3.2.1 E,C,R,S, 4.3.2.3 4.3.2.1 E,C,R,S, 4.3.2.1 S, 4.3.2.1 S, 10 20
4.3.2 4.3.2.1 DM DB A B 10 12 A 7 B 8 A B 15 DM CDISC 24 3 21
4.3.2.2 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
CSP 23 10 24 1024 1 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 4.3.2.3 Annotated CRF Annotated CRF DB Annotated CRF DB CRF DB Annotated CRF Annotated CRF CRF 23
4.3.3 4.3.2 11 DB 24
11 25
4.4 LPO DBL 4.4.1 LPO DBL 12 CRF MedDRA CRF DBL LPO CRF 29.1 LPO CRF 13.5 26
E,C,R,S, E,C,R,S 4.4.2.1 C,R,S 4.4.2.3 4.4.2.4 E,R,S 4.4.2.5 4.4.2.6 C,R 4.4.2.2 E,C,R,S 12 27
4.4.2 4.4.2.1 CRF LPO CRF SDV DBL CRF SDV CRF LPO DBL CRF SDV LPO DBL DM CRF CRF CRF CRF EDC EDC CRF DBL 4.4.2.2 CRF 1 28
CSP CRF CSP CRF LPO DBL CSP CSP ICH-E9 Q Q9. ( ) CRF KOL DBL EDC EDC 29
50 75% Living Document CSP CSP CSP 4.4.2.3 CRF DM SDV DM CRF DM DM 100 EDC ecrf 30
4.4.2.4 CRF CRF CRF DBL LPO DBL LPO DBL CSP CRF CRF DBL DBL LPO 4.4.2.5 CRF DBL CRF LPO DBL 1 31
DBL CRF CRF CRF DB Data Clarification Form CRF DM 21 6 4.4.2.6 SAE Reconciliation 4.4.2.2 CRF LPO SAE Reconciliation 3 LPO 3 LPO % LPO LPO 4.4.3 4.4.2 13 LPO CRF LPO LPO DBL 32
13 33
4.5 11 13 3.2.2 * 17 3 4 3 FTE (B) FTE (A)-(B) 4 (B) (A)-(B) * 17 3.2.2 34
4.6 ECRS PDCA 2009 EDC CRF CRF EDC EDC CRF EDC EDC 35
5 KAIZEN KAIZEN KAIZEN IT EDC TQM KAIZEN 36
A 1 Annotated CRF acrf acrf Annotated Case Report Form CRF 2 CDISC CDISC Clinical Data Interchange Standards Consortium CDISC CDISC CDISC http://www.cdisc.org/ 3 CRF CRF Case Report Form CRF CRF Visit Book Visit Book Book 4 CRF CRF 37
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 1 2 11 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
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
22 SDV SDV Source Data Verification Source Document Verification 23 CRF 24 25 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 29 30 CRF 31 DBL DBL Database Lock 32 40
33 34 - - DB URS DB UAT URS UAT 35 CRF CRF CDASH 36 DB SDTM 37 38 39 40 CRF 41 Blind Review 42 CRF 41
CRF 42
B 23 B- 1 CSP DB B- 2 CRF 43
B- 3 DMP B- 4 CRF 44
B- 5 DB B- 6 Annotated CRF 45
B- 7 DB B- 8 46
B- 9 B- 10 47
B- 11 48
B- 12 LPO DBL B- 13 LPO CRF 49
B- 14 LPO CRF B- 15 50
B- 16 DB 51
KAIZEN 3 23 3 22 3 22 3 22 5 22 5 23 5 23 5 RI 23 7 23 7 DM