A Proposal for Optimization of Clinical Trial by Central Monitoring System Consolidation by Applying the Operation Center and Electronic Data Sharing System 2.0 1 2 2 3 4 5 6 7 8 8 9 10 11 12 13 14 1 1 ACRONET 2 3 4 5 AC 6 7 8 9 10 11 12 13 14 Working Group 03 of the Monitoring 2.0 Group Masakazu Kitagawa and Sachiko MaezonoACRONET Corp.Atsushi Ujihara and Tatsuya WatanabeKitasato University Kitasato Institute HospitalSoichiro NishijimaDaiichi Sankyo Co., Ltd.Fumie MiwaLundbeck Japan K.K.Kazuki InoueAC Medical Inc. Yoichi ShiotaOtsuka Pharmaceutical Factory, Inc.Kei MitsuyamaIQSCo., Ltd.Masashi Odani and Hiromasa TakahashiCIMIC Co., Ltd.Mitsuru SugiyamaBell Medical Solutions Inc.Takako MiyazakiEPMint Co., Ltd.Shuji FukunagaJapanese Red Cross Narita HospitalMasaru HataPharmaMedicalSolution Inc.Chikako MinamiJapan Pharmacy Corp.Kyoko MochizukiNEUES Corp. S111
ABSTRACT ObjectivesWe propose a concrete model of IT using central monitoring system, to optimize the process of clinical trial. MethodsWe assessed every process of current monitoring practices and discriminated the process which can be conducted by monitoring. Furthermore, we researched more efficient monitoring practices by consolidated information and use of IT system. ResultWe proposed the Project Portal Site for the institutions, sponsors, CROs and SMOs to share and exchange all study related information. Sponsor s Operation Center manages the Project Portal Site and conducts the monitoring. We listed the functions of Project Portal Site and tasks of Operation Center. We estimated that this model is able to reduce the monitoring practices more than 40 compare to the ordinary practice. ConclusionThe proposed IT based central monitoring system might be able to contribute to improve the quality in terms of information sharing and consolidation by drastic reduction of monitoring related number of manhour. Jpn Pharmacol Ther 201341 suppl 2S11120 KEY WORDSCentral Monitoring, GCP, Clinical operation ICHGCP GCP 21 23.1 1 2011 Reflection paper on risk based quality management in clinical trialsema 1 Oversight of Clinical InvestigationsA RiskBased Approach to Monitoring FDA 2 EFPIA OnOff Site 3 2.0 IT 2.0 CROSMOIT 1 10 2011 4 2012 2 EDCelectronic data capture IT S112
IT IT IT GCP Web Project Portal SitePPS Operation CenterOC Off Site 1 147 116 79 IT PPS OC 1 1 OC PPS OC PPS OC PPS EDC IDPassword SSL ASPApplication Service Provider PPS 2 2 3 PPS IT Web OC PPS 3 PPS OC PPS OC QC 4 5 PPS OC 1 14 8 40 4 GCP ICHGCP S113
1 On 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 HP HP IRB Laboratory Certification SAE SMO SMO ICF ICF ICF 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 FDA1572 Financial Disclosure IRB IRB IRB IRB IRB EDC EDC Investigator s Meeting Investigator s Meeting EDC Site S114
1 GCP 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 IB ICF ICF ICF ICF ICF ICF 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111 112 113 SAE SAE SAE GCP GCP SDVCRF 84 85 86 87 88 89 90 91 92 93 94 95 96 IRB IRB IRB 1 1 114 115 116 117 118 CRC 119 120 121 SAE 122 CRFEDC 123 CRFEDC 124 CRFEDC 125 CRFEDC 126 CRFEDC 127 CRFEDC 128 129 130 131 S115
1 On 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 Financial Disclosure 1 GCP IT GCP 10 GCP 10 IT IT PPS IT OC PPS IT Clinical Trial PPS OC 40 OC S116
2 FAQ DB PPS IRB Certified Copy Certified Copy CVForm1572Lab. Certification Financial Disclosure EDC IRB SAE OC SAE ICF OC 2PPS Certified Copy S117
3PPS 3 PPS PPS FAQ SMO ICF SAE PPS PPS PPS DB CVForm1572ICF Certified Copy PPS EDCPPS EDC OC DM PPS IT e Web PPS OC S118
4 1 PPS UP 5 7 2 PPS 3 ICF PPS 4 6 IRB 8 ICF 9 PPS 5 2 PPS UP 5 PPS UP 8 1089 1 PPS UP 3 OC 12 4 PPS UP 6 13 7 FIX PPS UP 46 9 OC 11PPS 4 S119
GCP OC OC ongoing 2.0 IRB SDV 4 CROSMO IT 1Reflection paper on risk based quality management in clinical trials EMA. http: www.ema.europa.eudocs en_gbdocument_libraryscientific_guideline201108 WC500110059.pdf 2Guidance for IndustryOversight of Clinical InvestigationsA RiskBased Approach to Monitoring FDA. http:www.fda.govdownloadsdrugsguidancecom plianceregulatoryinformationguidancesucm269919.pdf 3 On 201142 SupplS294 4 2.0 http: www.moni2.orgmoni2wg.htm S120