YC41S213.ec Jpn Pharmacol Ther vol. 41 supplement 2013 A Proposal for Optimization of Clinical Trial by Central Monitoring System Consolidat
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1 A Proposal for Optimization of Clinical Trial by Central Monitoring System Consolidation by Applying the Operation Center and Electronic Data Sharing System ACRONET AC 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
2 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 suppl 2S11120 KEY WORDSCentral Monitoring, GCP, Clinical operation ICHGCP GCP Reflection paper on risk based quality management in clinical trialsema 1 Oversight of Clinical InvestigationsA RiskBased Approach to Monitoring FDA 2 EFPIA OnOff Site IT 2.0 CROSMOIT EDCelectronic data capture IT S112
3 IT IT IT GCP Web Project Portal SitePPS Operation CenterOC Off Site IT PPS OC 1 1 OC PPS OC PPS OC PPS EDC IDPassword SSL ASPApplication Service Provider PPS PPS IT Web OC PPS 3 PPS OC PPS OC QC 4 5 PPS OC GCP ICHGCP S113
4 1 On HP HP IRB Laboratory Certification SAE SMO SMO ICF ICF ICF FDA1572 Financial Disclosure IRB IRB IRB IRB IRB EDC EDC Investigator s Meeting Investigator s Meeting EDC Site S114
5 1 GCP IB ICF ICF ICF ICF ICF ICF SAE SAE SAE GCP GCP SDVCRF IRB IRB IRB CRC SAE 122 CRFEDC 123 CRFEDC 124 CRFEDC 125 CRFEDC 126 CRFEDC 127 CRFEDC S115
6 1 On Financial Disclosure 1 GCP IT GCP 10 GCP 10 IT IT PPS IT OC PPS IT Clinical Trial PPS OC 40 OC S116
7 2 FAQ DB PPS IRB Certified Copy Certified Copy CVForm1572Lab. Certification Financial Disclosure EDC IRB SAE OC SAE ICF OC 2PPS Certified Copy S117
8 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
9 4 1 PPS UP PPS 3 ICF PPS 4 6 IRB 8 ICF 9 PPS 5 2 PPS UP 5 PPS UP PPS UP 3 OC 12 4 PPS UP FIX PPS UP 46 9 OC 11PPS 4 S119
10 GCP OC OC ongoing 2.0 IRB SDV 4 CROSMO IT 1Reflection paper on risk based quality management in clinical trials EMA. http: en_gbdocument_libraryscientific_guideline WC pdf 2Guidance for IndustryOversight of Clinical InvestigationsA RiskBased Approach to Monitoring FDA. plianceregulatoryinformationguidancesucm pdf 3 On SupplS http: S120
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