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Implementation and Operation of CDISC ODM-based EDC by UMIN

Takahiro Kiuchi, M.D., Ph.D.

UMIN Center, The University of Tokyo Hospital,

Tokyo, Japan

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Content

1. CDISC standards and academic research2. What is UMIN and UMIN INDICE?3. Implementation and operation of CDISC

ODM-based EDC by UMIN4. Practical development and operation of a real

clinical trial by CDISC ODM-based EDC with Fukushima Prefectural University Hospital

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1. CDISC standards and academic research

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What is CDISC?

CDISC: Clinical Data Interchange Standards Consortium

(Non-profit organization for standardization)

Mission: The CDISC mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

(cited from CDISC website)

Members: Pharma, CRO, IT Vendors

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CDISC Standards1. SDTM Study Data Tabulation Model (SAS.xpt）

2. SEND Standard Exchange for Non-clinical Data (SAS.xpt)

3. ADaM Analysis Dataset Model (SAS.xpt）

4. CRT-DDS Case Report Tabulation and Data Definition Specification (PDF or XML)

5. ODM Operational Data Model (XML)

6. LAB Clinical Laboratory Model (ASCII, SAS.xpt, or XML)

7. PR Protocol Representation (UML)

8.CDASH Clinical Data Acquisition Standards Harmonization(Standardized variables for CRF)

NDA

Data transfer

Study design

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CDISC Standards for regulatory clinical trials

Practical use in U.S.A.

LabLab（XML）

ODM（XML） SDTM (Clinical)

SEND (Non-clinical)ADaM (Statistical analysis)⇒SAS xpt

CRT-DDS (Metadata)⇒PDF or XML

SDTMSENDADaM

SDTMSENDADaM

CDASH(Variable names)PR(Protocol)

Clinical laboratory company

（XML）

Regulatory agency

Hospital PharmaTrial use in U.S.A. and Europe

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CDISC Standards for academic research

LabLab（XML）

ODM（XML）

SDTMADaM

CDASH(Variable names)PR(Protocol)

（XML）

Academic publishers

Hospital Academicdata center

Paper

CDISC Standards can be used for academic clinical trials and epidemiological studies as they are.

Clinical laboratory company

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CDISC Standards and ICH

EMA PMDA FDA

ICH

CDISC Standards(Individual clinical data)

A Pharma B Pharma C Pharma

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CDISC Standards for FDA, Pharma, Hospital

CDISC StandardsRecommendation->Obligation

FDA

Pharma

Hospital

CDISC Standards compatible clinical datamanagement system

CDISC ODMdata interfacefor clinical research

Proprietary clinical data management system

Vendor proprietary data interface for clinical research

CDISC SDTMData conversion

CDISC SDTM CDISC SDTM

CDISC ODM

CDISC StandardsRecommendation->Obligation

CDISC StandardsRecommendation->Obligation

CDISC Standards compatible clinical datamanagement system

Vendor proprietary data interface for clinical research

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2. What is UMIN and UMIN INDICE?

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UMIN (University hospital Medical Information Network)

• Important information infrastructure for academic activities in biomedicine

• Versatile academic information services, including research, education, and clinical practice

The Univ. of TokyoHospital

National University Hospital CouncilControl 320 thousands

Registered users

50 million page views per month

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UMIN Services -Overview

Information and database services

Homepage etc. hosting services

Communication support services

Research Education

Clinical practice University hospitals

Multipurpose

Collection of biomedical web sites

Medical terms glossary

Research institutes and hospitals database

Open homepage hosting service

Member-only homepage hosting service

Archival homepage hosting service

Wiki

Blog

VOD hosting service

Email service, including encrypted email

Mailing list service

BBS service

Online voting system

Intoxication database (Yamaguchi Univ.)

HIV manual (Hokkaido Univ.)

Drug information database

Drug information text database for pharmacists

Medical supplies and materials database

Official documents database

University hospitals guide

Master database for patient fee calculation

Standardized disease nomenclature database

Mailing lists

Member-only homepages

AC Academic societies and meetings databaseELBISElectronic Library for Biomedical SciencesFINDFund Information DatabaseINDICEInternet Data and Information CenterROCOLSRecruiting System for Our Colleaguesand StudentsCTRICMJ-accredited clinical trial registry

EPOCOnline evaluating system of post-graduate clinical training for physicians

DebutOnline evaluating system of post-graduate clinical training for dentists

Web-QME Web-based Quality Management system for Educational effectiveness

VHPVisible Human Project image data

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UMIN INDICE (Internet Data and Information Center for Clinical Research)

ＵＭＩＮ

INDICE

Information

Communication Mailing list managementsystem

Homepage hosting service

Original software package for clinical and epidemiologicalresearch

Largest internet clinical research data center in JapanSaaS = Software as a Service

Hardware

Security

User management

Internet

Data collection

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Usage statistics of UMIN INDICE

0

200000

400000

600000

800000

1000000

1200000

Apr-00 Apr-02 Apr-04 Apr-06 Apr-08 Apr-100

20

40

60

80

100

120

140

160

180

April-00 April-02 April-04 April-06 April-08 April-10

Accummulated

Under operation

155 research projects One million of registered cases

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Web-based data collection by UMIN

Web browser

UMIN INDICE

UMIN CenterHospital

Manual entry of digitalized laboratory and drug prescription data(laborious and vulnerable to miss transcription)

Web-based

Electronic Health Record

Laboratory dataDrug prescription

Internet

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3. Implementation and operation of CDISC ODM-based EDC by UMIN

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Web-based data collection by UMIN

Web browser

UMIN INDICE

UMIN CenterHospital

Manual entry of digitalized laboratory and drug prescription data(laborious and vulnerable to miss transcription)

Web-based

Electronic Health Record

Laboratory dataDrug prescription

Internet

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Procedure for developing CDISC ODM-based EDC in UMIN

1. Analysis of a protocol and CRFs

2. Development of web-based EDC server system

3. Development of routine which processes CDISC ODM- based data and accommodate them to web-based EDC server system

4. Development of routine which extract trial data from web-based EDC server system and create CDISC ODM- based data.

5. Development of templates of CDISC ODM which are sent from hospitals to UMIN.

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CDISC ODM and Web-based data collection by UMIN (2009/11/6)

Web browser

UMIN INDICE

UMIN CenterHospital

Manual entry of digitalized laboratory and drug prescription data(laborious and vulnerable to miss transcription)

Web-based

Electronic Health Record

Laboratory dataDrug prescription

InternetCDISC ODM- based

Full or semi-automated fulfillment of digitalized laboratory and drug prescription dataEntry of other data from electronic health record

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UMIN needs partner hospitals for CDISC ODM-based EDC

UMIN could receive CDISC ODM data in early 2009.

But were there any hospitals which develop CDISC ODM-based research data submission system linked to EHR, using their own funds?=> There were two university hospitals!

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Implemention strategy for development of CDISC ODM-based research data submission system linked to EHR

Data automatically or semi-automatically collected from EHR are limited to demographic, laboratory, and drug prescription data, which usually covers more than half of trial data.

RFD (Retrieve Form for Data), which is based on XForm technology, is not used because the technology is immature and the implementation cost is expensive.

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Implementation procedure for development of CDISC ODM-based research data submission system linked to EHR

1. Development of CRF entry system

2. Development of a routine for automated or semi-automated fulfillment of demographic, laboratory, and drug prescription data

3. Development of a routine for checking CRF data

4. Development of a routine for creating CDISC ODM from CRF data

5. Submission of CDISC ODM-based data

TP 4.5mg/dlCr 1.1mg/dl

TP 4.5mg/dlCr 1.1mg/dlTC mg/dl

Automated entry

Deficit check

TP 4.5mg/dlCr 1.1mg/dlTC110mg/dl

TP 4.5mg/dl Manual entry

CDISC ODM Conversion

to CDISC ODM

CDISC ODM-baseddata submission

CRF entry system

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Future perspective of the development of CDISC ODM-based research data submission system linked to EHR

Packaging

1. Proprietary implementation of each hospital for each trial2. Vendor packaging 1)Vendor-specific module installed by a vendor for each trial2)Vendor-specific module installed by a hospital for each trial3)Vendor-specific module automated installed online for each trial4)CDISC standardized module automated installed online for each trial

Development in most EHR vendors

Interoperability of CDISC ODM

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4. Practical development and operation of a real clinical trial by CDISC ODM-based EDC with Fukushima Prefectural University Hospital

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Overview of the clinical trial

TitleEffect of topping up of Toremifene to preoperative chemotherapy of breast cancer

Principal investigatorsSeiichi Takenouchi and Tohru Ohtake

The number of cases planned 20 cases

The number of participant institutions7 hospitals, including Fukushima Prefectural Univ. Hospital

The study start date Nov. 9th, 2009

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EHR and CRF data entry form

EHR

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CRF data entry formAutomated fulfillment

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Using Yahgee for the implementation(1)

What is Yahgee1)Software tool

Data entry forms can be developed and corrected by users themselves (hospitals).

2)Interface for most EHRs sold in JapanData can be entered and extracted from most EHRs sold in Japan through Yahgee.

Yahgee

A company’sEHR

B company’s EHR

C company’sEHR

Yahgee YahgeeYahgee interfaceYahgee interfaceYahgee interface

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Using Yahgee for the implementation(2)

Webinterface

CDISC ODMinterface

CDISC ODMinterface

CDISC ODMinterface

UMIN INDICE

A company’sEHR

B company’sEHR

Yahgee

A company’sEHR

B company’sEHR

YahgeeYaghee interfaceYaghee intereface

CDISC ODM interfaceCDISC ODM interface

Fukushima Prefectural Univ. hospital

R hospitalP hospital Q hospital

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Why the real clinical trial, based on CDISC ODM, realized in Japan first.

Realized as an academic (non-profit) clinical trial ・It is difficult to realize a real EDC in regulatory data collection, using new and

immature technology like CDISC Standards. ・CDISC Standards are misunderstood as those for only new drug application. In

fact, their scope are much wider now.・Pharma companies concern obligatory CDISC-based new drug application over

CDISC-based EDC.

Web-based academic EDC system - UMIN INDICE

Practical approach for the development of CDISC ODM-based research data submission system linked to EHR

1) Data collected from EHR are limited to demographic, laboratory, and drug prescription data.2) RFD (Retrieve Form for Data) is not used because the technology is immature and the implementation cost is expensive.

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Thank you for your attention.

The presenter’s doctor thesisResearch on the Use of World Wide Web for a Data Management System for Use in Multi-institutional Clinical Trials

Published papers related to the doctor thesis1) Kiuchi T, Ohashi Y, Konishi M, Bandai Y, Kosuge T, Kakizoe T: A World Wide Web-based user interface for a data management system for use in multi- institutional clinical trials - Development and experimental operation of an automated patient registration and random allocation system. Controlled Clinical Trials 17:476-493, 1996 2) Kiuchi T, Kaihara S: C-HTTP - The development of a secure, closed HTTP- based network on the Internet. Proceedings of the 1996 Symposium on Network and Distributed System Security, IEEE Computer Society Press, 64-75, 19963) Kiuchi T, Kaihara S: Automated generation of a World Wide Web-based data entry and check program for medical applications. Computer Methods and Programs in Biomedicine 52:129-138, 1997