Program Chairs Sue Dubman, MA Senior Director, Biomedical Data Sciences and Informatics, Genzyme Corporation Don Rosen Principal, Don Rosen Consulting Program Committee Laurie Callen Senior Technical Manager, Clinical Data Management, Synta Pharmaceuticals Corporation Brandon Díaz Senior Project Manager, OmniComm Systems, Inc. Shahla S. Farr Biostatistical Reviewer, CDER, FDA Rebecca D. Kush, PhD President and CEO, CDISC Denise DeRenzo Lacey, MA, MS Director, Business Operations, Vertex Pharmaceuticals Incorporated Annette L. Mathisen, PhD Senior Director, Client Services, QST Consultations, Ltd. Frank T. Newby Chief Operating Officer, CDISC Johann Pröve, PhD Global Head Data Management, Bayer Schering Pharma, Germany Eric A. Tate Manager, Clinical Coding, Clinical Data Management, MedImmune Stephen E. Wilson, DrPH, CAPT. USPHS Director, Division of Biometrics III, CDER, FDA Monitor the website for the most current details. www.diahome.org DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: [email protected]Multitrack Conference to Discuss Standards, Processes, and Infrastructure across the Clinical Data Lifecycle Learn the latest information in processing across the clinical data lifecycle, end-to-end, from trial design through submission, particularly focused on standards-based, metadata-driven approaches. Sessions and presentations will focus on: • Efficiency, streamlined processes, and improved quality through the implementation of standards-based, metadata-driven processing across the clinical data lifecycle • Case studies that address the challenges of data integration across the clinical data lifecycle • Tools and processes required to build an appropriate foundation for implementing standards-based, metadata-driven processing across the clinical data lifecycle 24th Annual DIA Data Conference and Exhibition CLINICAL DATA LIFECYCLE Trial Design through Submission and Beyond THIS PROGRAM WAS DEVELOPED BY THE CLINICAL DATA MANAGEMENT AND eCLINICAL SPECIAL INTEREST AREA COMMUNITIES MARCH 9-11, 2009 (March 9 – Tutorials only) Marriott Philadelphia Downtown Philadelphia, PA, USA 24TH ANNUAL DIA Session Topics Special Features • Senior management roundtable and panel discussions in each of the tracks • Keynote Address and an FDA Update Session in a Plenary Town Hall format Track 1 – Standards • Overviews of HL7 and CDISC: History and Common Goals/Commitments • Experiences in Implementing Data Submission Standards Encompassed in Any eCTD • FDA IT Strategy and the CDISC Content to HL7 Message • ICSR and Harmonization of AE standards in BRIDG • Protocol Representation Standard – A Joint Project Using BRIDG • Standards Across the Health Care Ecosystem Track 2 – Processes • Best Practices for Standards-Based, Metadata-Driven Processes in Trial Design, Data Collection and Processing, Archiving and Storage, Analysis and Reporting, Compilations, and Submissions • Organizational Change Management to Support Transformation of Clinical Data Processes • Clinical Information Standards Governance • The Changing Role of Clinical Data Managers: Clinical Data Management at a Crossroads • Facilitating Exchange of Information With Your Third-Party Vendors and Partners • Electronic Data Capture and Clinical Data Management Career Paths Track 3 – Infrastructure • Technology to support standards-based, metadata-driven processing across the clinical data lifecycle – Senior Management Roundtable Discussion • Clinical data integration challenges and solutions, both internally and across the broader health care system – covering data access, transformation, persistence and distribution in a compliant framework across the clinical data lifecycle – to include EDC and data integration • Ontology Management – Data Element Repositories, Vocabulary and Terminology Services, BRIDG Information Model, Semantic Web • Protecting and ensuring the integrity of clinical data end-to-end (authorization and authen- tication, electronic signatures, data lock processing, auditing , etc.) and/or Statistical meth- ods of fraud detection • Integrated statistical computing environments or more on EDC and data integration • Standards-based clinical data repositories to support integration across the clinical data lifecycle
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Program ChairsSue Dubman, MASenior Director, Biomedical Data Sciences andInformatics, Genzyme CorporationDon RosenPrincipal, Don Rosen Consulting
Program CommitteeLaurie CallenSenior Technical Manager, Clinical DataManagement, Synta Pharmaceuticals CorporationBrandon DíazSenior Project Manager, OmniComm Systems, Inc.Shahla S. FarrBiostatistical Reviewer, CDER, FDARebecca D. Kush, PhDPresident and CEO, CDISCDenise DeRenzo Lacey, MA, MSDirector, Business Operations, VertexPharmaceuticals IncorporatedAnnette L. Mathisen, PhDSenior Director, Client Services, QSTConsultations, Ltd.Frank T. Newby Chief Operating Officer, CDISCJohann Pröve, PhDGlobal Head Data Management, Bayer ScheringPharma, GermanyEric A. TateManager, Clinical Coding, Clinical DataManagement, MedImmuneStephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA
Monitor the website for the most current details. www.diahome.orgDIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: [email protected]
Multitrack Conference to Discuss Standards, Processes, andInfrastructure across the Clinical Data LifecycleLearn the latest information in processing across the clinical data lifecycle, end-to-end, fromtrial design through submission, particularly focused on standards-based, metadata-drivenapproaches. Sessions and presentations will focus on:
• Efficiency, streamlined processes, and improved quality through the implementation ofstandards-based, metadata-driven processing across the clinical data lifecycle
• Case studies that address the challenges of data integration across the clinical data lifecycle• Tools and processes required to build an appropriate foundation for implementing
standards-based, metadata-driven processing across the clinical data lifecycle
24th Annual DIA Data Conference and Exhibition
CLINICAL DATA LIFECYCLETrial Design through Submission and Beyond
THIS PROGRAM WAS DEVELOPED BY THECLINICAL DATA MANAGEMENT AND eCLINICALSPECIAL INTEREST AREA COMMUNITIES
MARCH 9-11, 2009(March 9 – Tutorials only)
Marriott Philadelphia DowntownPhiladelphia, PA, USA
24TH ANNUAL DIA
Session Topics
Special Features• Senior management roundtable and panel discussions in each of the tracks• Keynote Address and an FDA Update Session in a Plenary Town Hall format
Track 1 – Standards• Overviews of HL7 and CDISC: History and Common Goals/Commitments
• Experiences in Implementing Data Submission Standards Encompassed in Any eCTD
• FDA IT Strategy and the CDISC Content to HL7 Message
• ICSR and Harmonization of AE standards in BRIDG
• Protocol Representation Standard – A Joint Project Using BRIDG
• Standards Across the Health Care Ecosystem
Track 2 – Processes• Best Practices for Standards-Based, Metadata-Driven Processes in Trial Design, Data
Collection and Processing, Archiving and Storage, Analysis and Reporting, Compilations,and Submissions
• Organizational Change Management to Support Transformation of Clinical Data Processes
• Clinical Information Standards Governance
• The Changing Role of Clinical Data Managers: Clinical Data Management at a Crossroads
• Facilitating Exchange of Information With Your Third-Party Vendors and Partners
• Electronic Data Capture and Clinical Data Management Career Paths
Track 3 – Infrastructure• Technology to support standards-based, metadata-driven processing across the clinical data
• Clinical data integration challenges and solutions, both internally and across the broaderhealth care system – covering data access, transformation, persistence and distribution in acompliant framework across the clinical data lifecycle – to include EDC and data integration
• Ontology Management – Data Element Repositories, Vocabulary and Terminology Services,BRIDG Information Model, Semantic Web
• Protecting and ensuring the integrity of clinical data end-to-end (authorization and authen-tication, electronic signatures, data lock processing, auditing , etc.) and/or Statistical meth-ods of fraud detection
• Integrated statistical computing environments or more on EDC and data integration
• Standards-based clinical data repositories to support integration across the clinical data lifecycle
3 - 3:30pm Refreshment Break in the Exhibit Hall
3:30 - 5pm Parallel Tracks — Session 2
5 - 6pm Networking Reception
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Conference at a Glance
CDISC and HL7: A Collaborative andComplementary Relationship
Introductory History, Overview, and Status of the CDISC-HL7 Relationship
The HL7 RCRIM Workgroup and Joint CDISC-HL7 Projects
The Power of Working Together
1 - StandardsBest Practices for Standards-based, Metadata-driven
Processes in Trial Design, Data Collection andProcessing, Archiving and Storage, Analysis and
Reporting, Compilations, and Submissions
How the Use of Metrics Highlights the Need for Consistent Terminology
2 - ProcessesStreamlining Your Clinical Data Environment,
End-to-end, Using a Standards-based, Metadata-driven Approach
Initial Steps to Develop an End-to-end, Standards-based,Metadata-driven Clinical Data Lifecycle
Are You Building a Bicycle or a Car? Development Data Management Requires a Paradigm Shift
Reinventing Clinical Data Life-cycle Processes
3 - Infrastructure
Experiences in Implementing Data SubmissionStandards Encompassed in any eCTD
(SDTM, ADaM and Define.XML)
SDTM Data Validation and the Key Role It Plays in Your Submissions
Legacy Clinical Trial Data: Challenges and Solutions
1 - StandardsOrganizational Change Management to Support
Transformation of Clinical Data Processes
The New Face of Data Management
How CROs and EDC Providers Are Partnering toDeliver eTechnologies in Large, Global Studies
2 - ProcessesClinical Data Integration Challenges and Solutions
A Knowledge Management Approach for the Integration of Trial Design, Execution and Evaluation
Clinical Data Integration, Analysis and Reporting Using Oracle’s Life Sciences Data Hub (LSH)
The eClinical Continuum
3 - Infrastructure
MONDAY, MARCH 9, 2009
7:00 - 8:30am Tutorial Registration
8:30am - 12:00pm Morning Tutorials#1 Managing Projects and Being Project Managed#2 CDISC Submission Standards from FDA Perspective (SDTM, ADaM, and Define.XML)
10am - 3pm Exhibitor Registration and Booth Set-up
4 - 6pm Attendee and Speaker Registration/Exhibit Hall Open
5 - 6pm Reception in the Exhibit Hall
TUESDAY, MARCH 10, 2009
7:30 - 8:30am Registration and Continental Breakfast
9:00am Exhibit Hall Opens
8:30 - 8:45am Plenary Session 1: Welcome and Opening Remarks8:45 - 9:30am KEYNOTE ADDRESS –Ken Buetow, PhD, Associate Director for Bioinformatics and Information Technology, National
Cancer Institute, Center for Bioinformatics and Information Technology
9:30 - 10am Refreshment Break in the Exhibit Hall
10am - 12pm Plenary Session 2: FDA Update Session
12 - 1:30pm Luncheon
1:30 - 3pm Parallel Tracks — Session 1
CANCELLED
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WEDNESDAY, MARCH 11, 2009
5pm Conference Adjourned
7:30 - 8:30am Registration and Continental Breakfast
9:30am Exhibit Hall Opens
8:30 - 10am Parallel Tracks — Session 3
10 - 10:30am Refreshment Break in the Exhibit Hall
10:30am - 12pm Parallel Tracks — Session 4
12 - 1:30pm Luncheon in the Exhibit Hall
1:30 - 3pm Parallel Tracks — Session 5
Developing the CDISC Content to HL7 Message
FDA Perspective on the Development of CDISC Content to HL7 Messages
CDISC Perspective on the Development of CDISC Content to HL7 Messages
1 - StandardsClinical Information Standards Governance
Standards Governance - Managing the Implementation of Enterprise-wide Data Standards
Streamlining and Standardizing Electronic Data Collection for Phase I Clinical Trials
An Enterprise Scale Integrated Research Platform
2 - ProcessesOntology Management – Data Element
Repositories, Vocabulary and Terminology Services,BRIDG Information Model, Semantic Web
Controlled Terminology: Let’s Speak the Same Language!
NCI Common Terminology Criteria for Adverse EventsRevision and Compliance with MedDRA®
A Terminology Authoring Platform Built on Semantic Media Wiki
Harmonization of MedDRA® Versioning BetweenIndustry and Regulators and Between Industry Partners
Analysis of Concomitant Medication and Standardized Drug Queries (SDQs)
3 - Infrastructure
Protocol – The Recipe for a Successful Trial
Introduction to the CDISC-HL/7 Protocol Representation Standard:
A BRIDG to Interoperability
EDC is in the Middle – The End-to-End eClinical Vision Starts with the Protocol
An Open-source Clinical Protocol Lifecycle Tracker (PLT)
1 - StandardsFacilitating Exchange of Information with
Your Third-party Vendors and Partners
Efficient Communication and Managing Third-party Vendors
Leading Virtual Teams
Communication in Virtual Teams:The Vital Clinical Data Lifecycle Link
What, Why, and How: Statistical Computing Environments
and their Role in Completing the Electronic Clinical Data Lifecycle
SCE: The Current State and Needs of a Regulatory Agency from a Reviewer’s Perspective
3 - Infrastructure
ICSR and Harmonization of AE Standards inBRIDG
The Individual Case Safety Report
Harmonizing Adverse Event Standards into BRIDG
Leveraging Electronic Health Records for Safety Reporting
1 - StandardsThe Changing Role of Clinical Data Managers:
Clinical Data Management at a CrossroadsThe Changing Role of Data Managers
The Changing Role of the Clinical Data Manager in a Globalized Environment
Value Added by Data Management:How Could We Achieve This?
2 - ProcessesProtecting the Integrity of Clinical Data End-to-end
Computerized Systems in Clinical Research:Current Quality and Data Integrity Concepts
Improving Your Clinical Trial through Data Integration
Leveraging EDC in the Collection of Safety Data
3 - Infrastructure
Standards Across the Healthcare Ecosystem1 - Standards
Clinical Data Management Career Paths
Professional Pathways Beyond Clinical Data Management
EDC Developer Career Approach
Developing a Career Path with Electronic Data Capture
2 - ProcessesStandards-based Clinical Data
Repositories to Support Integration Across the Clinical Data Lifecycle
Perspectives on Data Repositories Using SDTM, Janus and HL7
Clinical Research Repositories as a Collaboration Platform
3 - Infrastructure
3 - 3:30pm Refreshment Break
3:30pm Exhibit Hall Closes
3:30 - 5pm Parallel Tracks — Session 6
CANCELLED
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The Drug Information Association (DIA) has been approved as an Authorized Provider by the InternationalAssociation for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA22102. DIA is authorized by IACET to offer 1.2 CEUs for this program.
To receive a statement of credit, please visit www.diahome.org. Detailed instructions on how to complete yourcredit request and download your certificate will be provided onsite.
Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activities must dis-close to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and (2) discus-sions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in the course materials.
Continuing Education Credit AllocationHalf-day Tutorials: .3 IACET CEUs Conference: 1.2 IACET CEUs (CEUs will not be offered for the plenary sessions.)
Learning ObjectivesAt the conclusion of this conference, participants should beable to:� Discuss how to better manage information collected during
clinical development, end-to-end, from trial design throughsubmission to regulatory authorities;
� Explain how other companies are making better decisionsbased on more accurate and timely information from acrossthe clinical data lifecycle, which, in turn, can accelerate theintroduction of new products, enhance productivity, man-age compliance, and reduce risk;
� Describe how other companies overcome clinical data inte-gration challenges and manage all aspects of the integrationprocess—data access, transformation, persistence and distri-bution—in a compliant framework across the clinical datalifecycle and across the broader health care system;
� Discuss best practices on the proper use of clinical datastandards, end-to-end;
� Outline the underlying core technology infrastructure thatis needed to roll out standards, end-end; and
� Explain how to define, implement, and maintain data standards.
Continuing Education Credits
Target Audience� Clinical data management professionals� Statisticians/biostatisticians� CRF and database designers� Information technology professionals� Regulatory affairs professionals� Data coordinators and reviewers
� Data monitors� Medical coders� Clinical professionals� Clinical project leaders� Clinical research professionals� Patient recruitment professionals
Exhibitor Information
Exhibitors (as of February 16, 2009)
Max Neeman InternationalMaxis IT Inc.Medidata SolutionsMedXview, Inc.Octagon Research Solutions, Inc. Perceptive InformaticsPhase Forward Prosoft Software, Inc.RPS, Inc.
Abt Bio-Pharma Solutions, Inc.Applied Clinical TrialsCDISC DataCeutics, Inc.DATATRAK InternationalDZS Software-ClinPlus ICON Clinical Research Inc ResearchKforce Clinical Research
Society for Clinical DataManagementStrataThe Uppsala Monitoring CentreUS OncologyWaban Software, Inc.United BioSource Corporation
Exhibit Hall Hours Monday, March 9 4 - 6pmThere will be an opening reception in the exhibit hall from 5 - 6pm.
Tuesday, March 10 9am - 6pmNetworking Reception from 5 - 6pm.
Wednesday, March 11 9:30am - 3:30pm
Coffee breaks & receptions will be held in the exhibit hall.
For more information, contact:Jeff Korn, Exhibits Associate telephone +1-215-442-6184email [email protected]
Monday, March 9, 2009 10am - 3pm – Exhibitor Registration and Booth Set-up
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Exhibit information
Monday, March 9, 2009 (Tutorials Only)
7 - 8:30am Tutorial Registration
8:30am - 12pm Tutorial 1
#1 Managing Projects and Being Project Managed(.3 IACET CEUs)
InstructorMark Vieder, RPh, MBA Supervisor, FDA-AERPS Coding/QC, PSI International, Inc.Projects are a means of organizing activities that cannot beaddressed within an organization’s normal operational limits.Projects are considered a temporary endeavor that will create aunique product, service or result and once that establishedobjective is attained the project terminates. Projects can involvea single individual or many individuals within an organization,outside an organization or a combination of both. Project management would be an application of knowledge,skills, tools and techniques that would encompass the activitiesto meet project requirements. These steps may include initiat-ing, planning, executing, monitoring, controlling and closing ofthe project.
Managing Projects will allow an opportunity for attendees tobe placed in the position of project manager for an organizationthat has a strategic plan in place. Aspects to be considered are:Identifying requirements, establishing clear and achievableobjectives, balancing competing demands and adaptation.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Understand differences between a project and operations
within an organization.
� Understand the elements that constitute a project whichinclude: initiation, planning, executing, monitoring, control-ling and closing.
� Manage the project effectively to achieve the organization’sstrategic plan.
10am - 3pm Exhibitor Registration and Set-up
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8:30am - 12pm Tutorial 2
#2 CDISC Submission Standards from FDA Perspective(SDTM, ADaM and Define.XML) (.3 IACET CEUs)
InstructorsFrank T. Newby Chief Operating Officer, CDISC Stephen E. Wilson, DrPH, CAPT. USPHS Director, Division of Biometrics III, CDER, FDA
In May of 2008 the FDA released a final version of the PDUFAIV Information Technology Plan, anticipating the release of a pro-posed rule to require the electronic submission of standard data.This plan clearly states that SDTM will be the foundation forstandardized clinical content. Employing the data included in vol-untary standard data submissions, CDER is currently gainingexperience building tools, training reviewers and pushing hard todevelop processes and applications for using standard data inreviews of NDAs and BLAs.
To improve the efficiency of submission and review processes, it is
important for sponsors to know how “to do it right” (i.e., createand submit standard data that will comply with CDISC standardsfor content and format). This tutorial will provide background onSDTM-based eCTD, including the processes that submittingcompanies should undertake to help insure a technically success-ful submission.
This will be an opportunity to learn what the data modelingprocess is all about and to think about the benefits of adoptingCDISC standards. It will include an introduction to SDTM,ADaM and define.xml and to tools/methods used by CDERreviewers.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Describe the CDISC data models, format and content associ-
ated with SDTM and ADaM standards � Delineate the procedures required to ensure a technically suc-
cessful SDTM submission as part of an eCTD submission. � Explain what the FDA actually does with the data submitted
InstructorJulia Urbanchuk, MSDirector, Organizational Development & ChangeMerck & Co., Inc.Many forces (external and internal) are demanding radicaltransformation of development processes, organization andtechnology. These include: complex safety and efficacy require-ments, increased regulatory scrutiny and public focus onpatient safety, resource and monetary constraints, increasingcomplexity of trials, more competition for patients, globaliza-tion and increasing importance of partner collaborations andoutsourcing. Change is vital to sucess but change is very diffi-cult and many organizational change initiatives fail.
Leading Organizational Change is a hands-on workshop thatoffers the best insights from research and practice focused onaddressing your specific change initiatives. The program offersframeworks, models, and perspectives on leading change thatparticipants can immediately apply to their own projects.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Understand the factors that trip up promising organizational
transformations � Understand the strategies that can make organizational trans-
formations more successful. � Gain a better grasp of the complex interpersonal and strate-
gic issues involved to become a more effective change agentin your organization.
1:30pm - 5pm Tutorial 4
#4 CRF Standards – CDASH(.3 IACET CEUs)
InstructorsMelissa BenzDirector, Central Standards Group, WyethRhonda FacileCDASH Project Director, CDISC
Chris TolkDirector, Terminology, CDISC
Many DIA members will have by now already have heardabout the CDISC-led CDASH project. As review, theCDASH initiative is in follow-up to FDA Critical Path
Opportunity #45 that seeks to enable standardized collectionof clinical research data at investigative sites. Through stan-dardization of basic data collection elements, efficiencies canbe achieved that will result in less confusion across sponsors,investigators and research sites and facilitating more efficientmonitoring, audit, submission and review procedures.
This half-day tutorial will cover the background, and historyof the CDASH project, a survey of the 16 domains developed,including an overview of the CDASH standard. Practicalimplementation (CDASH-ODM) will be discussed as well as adiscussion of how CDASH relates to the Study Data TabulationModel (SDTM) and CDISC controlled terminology, whichruns through all CDISC standards. The session will concludewith a question and answer session.
Monday, March 9, 2009, Tutorials Only, continued
12 - 1:30pm Luncheon Break (Lunch is not served on tutorial day)
7:30 - 8:30am Registration and Continental Breakfast
4 - 6pm Registration (Attendees and Speakers) and Exhibit Hall Opens
5 - 6pm Reception in the Exhibit Hall
Welcome and Opening RemarksWilliam Brassington, MBAActing Executive Director, DIA
Sue Dubman, MA, Program ChairpersonSenior Director, Biomedical Data Sciences and Informatics,Genzyme Corporation
Keynote AddressKen Buetow, PhDAssociate Director for Bioinformatics and Information Technology,National Cancer Institute, Center for Bioinformatics andInformation Technology
Theresa Mullin, PhDAssistant Commissioner for Planning, office of the DirectorCDER, FDA
10am - 12pm Plenary Session 2
FDA Update
12 - 1:30pm Luncheon
9:30 - 10am Refreshment Break in the Exhibit Hall
Session Chairpersons
Stephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA
Kim W. Nitahara, MS, MBACEO, META Solutions Inc.
Globalization, law (The Food and Drug Administration AmendmentsAct of 2007 –FDAAA and PDUFA IV) and Agency initiatives (e.g.,The Critical Path) are all currently shaping new directions for prod-uct development, science and regulatory processes. The Agency ispushing forward simultaneously to assure quality, expedite drugdevelopment and to enhance the submission and review of applica-tions for new drugs, biologics and devices. The participants in thisannual FDA Update Session are all currently working to create newfutures for scientific and regulatory processes associated with the col-lection, analysis and review of data. They will describe progress andshare their views on a number of Agency activities and programs,including, for example: the development of vision and strategic plans;the planning for new guidance and regulations; the work to developnew standards for collection, submission and review tools (HL7,CDISC, SDTM, SEND, ADaM, etc.); the projects aimed atstreamlining clinical trials; the design of active surveillance and sen-tinel systems to more effectively study the safety of new products;efforts to assure compliance as we move to e-source and electronic
health record data; and the new developments and directions in thebuilding of data repositories (e.g., the Janus data warehouse).
What is the vision? How are we going to get there? What is theroadmap? How does all of this affect you? This is an opportunity fordata management and e-clinical professionals to listen, to learn andto be partners in these important improvements. Please bring yourknowledge, your problems, your questions, and your solutions tothis Annual FDA Update session.
Panelists
Leslie BallDivision Director, office of Compliance, CDER, FDAPatricia Beers BlockGood Clinical Practice Program (HF-340), Office of Science andHealth Coordination, Office of the Commissioner, FDAShahla S. FarrBiostatistical Reviewer, CDER, FDALeonard SacksDeputy Director, Office of Critical path Programs, OC, FDA
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Describe the benefits of CRF standardization for investiga-
tive sites and other stakeholders in clinical research. � Explain the CDISC Standards Development Process, and
where the CDASH project is relative to this process. � Explain how CDASH collection fields can be used to cre-
ate basic CRFs and XML style sheets and how this willfacilitate good CRF design and minimize collection of
unnecessary data elements and ensure consistency across aclinical program.
� Describe how CDASH data collection fields are related toother CDISC standards, specifically the SDTM andTerminology.
� Describe how CDASH can facilitate interoperabilitybetween clinical systems, e.g. facilitating collection of datafrom EHRs or between 2 clinical data systems between asingle or multiple CROs and Sponsors).
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1:30 - 3pm TRACK 3 – Infrastructure
1:30 - 3pm TRACK 2 – Processes
Streamlining Your Clinical Data Environment, End-to-end,Using a Standards-based, Metadata-driven ApproachSession ChairpersonSue Dubman, MASenior Director, Biomedical Data Sciences and Informatics,Genzyme Corporation
Panel discussion with senior leaders in the biopharmaceuticalindustry on how their companies are reinventing clinicaldevelopment processes via technology-enabled, standards-based, metadata-driven approach to managing clinical data end-to-end, across the entire clinical data lifecycle, from trialplanning through regulatory submission and beyond.
Initial Steps to Develop an End-to-end, Standards-based,Metadata-driven Clinical Data LifecycleBarry R. Cohen, MSSenior Director, Clinical Data StrategiesOctagon Research Solutions, Inc.
Are You Building a Bicycle or a Car? Development DataManagement Requires a Paradigm ShiftIsabelle M. de Zegher, MD, MScBelgium
Reinventing Clinical Data Life-cycle ProcessesDiana McKenzieVice President, Information Technology, Amgen
Best Practices for Standards-based, Metadata-drivenProcesses in Trial Design, Data Collection andProcessing, Archiving and Storage, Analysis andReporting, Compilations, and Submissions Session ChairpersonLaurie CallenSenior Technical Manager, Clinical DataManagement, Synta Pharmaceuticals Corporation
With the advent of electronic data submissions and the emer-gence of standards such as CDISC, the need for developing,augmenting or improving current clinical trial processes is nec-essary in order to achieve maximum efficiency, consistency,communication flow and ultimately higher quality.
In this session, case studies will be presented that detail howorganizations are incorporating CDISC and other metadata orterminology standards into their cross-functional processes andoperations. Strategies, impacts and challenges of incorporatingthese metadata-driven processes and a consistent terminologywill be discussed.
How the Use of Metrics Highlights the Need for ConsistentTerminologyRandy Krauss, PhDAssociate Director, Global BMRA Metrics, Genzyme Corporation
Stephen J. Ruberg, PhDSenior Research Fellow, Global Information Sciences, Eli Lilly andCompany
1:30 - 3pm TRACK 1 – Standards
CDISC and HL7: A Collaborative and ComplementaryRelationshipSession ChairpersonsCharles Jaffe, MD, PhDCEO, HL7Rebecca Kush, PhDPresident and CEO, CDISC
Health Level Seven (HL7) and the Clinical Data InterchangeStandards Consortium (CDISC), two global StandardsDeveloping Organizations, have had a Charter Agreement inplace since 2001. HL7 and CDISC have made a strong com-mitment to harmonize the respective standards for clinical careand medical research and to enable interoperability amonghealthcare and clinical research systems/applications. The ulti-mate goal is to improve the processes and efficiency for a robustinteroperable infrastructure such that healthcare advances med-ical research which in turn informs clinical care. In this session,
we will review the history and current status of the joint activitiesof CDISC and HL7. There will also be descriptions of specificjoint projects, including projects initiated by FDA and ICH.
Introductory History, Overview, and Status of the CDISC-HL7 RelationshipCharles Jaffe, MD, PhDCEO, HL7Rebecca Kush, PhDPresident and CEO, CDISC
The HL7 RCRIM Workgroup and Joint CDISC-HL7 ProjectsEdward S. Tripp President, Edward S Tripp and Associates Inc.
The Power of Working TogetherWilliam (Ed) HammondProfessor Biomedical Engineering, Duke University Medical Center,Chair HL7 and Joint Initiative Council for Harmonization ofHealth Informatics Technology Standards
Parallel Tracks, Session 1
3 - 3:30pm Refreshment Break in the Exhibit Hall
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Parallel Tracks, Session 2
3:30 - 5pm TRACK 3 – Infrastructure
3:30 - 5pm TRACK 2 – Processes
Clinical Data Integration Challenges and SolutionsSession ChairpersonTerry HardinPresident and CEO, PerfiTech Consulting
Data management organizations are increasingly facing thechallenge of integrating information across the clinical data lifecycle from sources both internal and external to their own and partner organizations. This session will address these issues and how companies are approaching solving them – covering data access, EDC, data integration andtransformation, data persistence and distribution in a standards compliant framework.
A Knowledge Management Approach for the Integration ofTrial Design, Execution and EvaluationDave ParrishDirector Informatics, The Immune Tolerance Network
Clinical Data Integration, Analysis and Reporting UsingOracle’s Life Sciences Data Hub (LSH)Carina SoldnerBusiness Project Manager for CDR, Boehringer Ingelheim, Germany
The eClinical ContinuumDavid B. SteinVice President, Product Management, Perceptive Informatics
Organizational Change Management to SupportTransformation of Clinical Data ProcessesSession ChairpersonJohann Pröve, PhDGlobal Head Data Management, Bayer Schering Pharma,Germany
This session will – on one hand – focus on the cooperationbetween a CRO and an EDC provider and the evolvingorganizational needs when moving to emerging markets.Secondly, the changing role of data management in theindustry will be elaborated on. Thirdly, the topic of functional sourcing and the impact on the organizationalstructure in data management will be addressed.
The New Face of Data ManagementAndrew Schafer, MBASenior Director, Strategic Resourcing, Quintiles TransnationalCorp.
How CROs and EDC Providers Are Partnering to DelivereTechnologies in Large, Global StudiesMichael P. Davies, PhD Vice President, Global CRO Partnerships, Phase Forward
Functional Sourcing: Evaluating Organizational StructureKeith Fine, MASenior Director, Functional Sourcing, Premier Research GroupLimited
3:30 - 5pm TRACK 1 – Standards
Experiences in Implementing Data Submission Standards Encompassed in any eCTD (SDTM, ADaM and Define.XML) Session ChairpersonFrank T. NewbyChief Operating Officer, CDISC
The eCTD (electronic Common Technical Document )finalguidance –– specifies the manner in which all submissions toFDA should (not yet required) be made. Included is a sectionon data specifications which point to CDISC standards as theformat for submitting data. This session will provide some
insight into the conversion of your existing data into those recom-mended CDISC standards and how you could validate that theconversion was done in compliance with the standards.SDTMData Validation and the Key Role It Plays in YourSubmissionsAnthony ChowManager, Octagon Research Solutions, Inc.
Legacy Clinical Trial Data: Challenges and SolutionsMichelle GayariDirector, Clinical Programming and Biostatistics, MMS Holdings,Inc.
5 - 6pm Networking Reception
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8:30 - 10am TRACK 2 – Processes
Clinical Information Standards GovernanceSession ChairpersonSue Dubman, MASenior Director, Biomedical Data Sciences and Informatics,Genzyme CorporationEffective data standards governance is critical to success in man-aging the implementation of enterprise-wide data standards.Appropriate standards governance ensures: standards strategiesand governance support an organization’s mission, consistency inimplementation of standards across the organization, consistencyin use and exchange of information, and appropriate coordina-tion among various standards initiatives. This session will startwith a discussion of the roles and responsibilities of a standardsgovernance organization within a company at the various phasesof implementation and production deployment of clinical datastandards, followed by several specific case studies.
Wednesday, March 11, 2009 Parallel Tracks, Session 3
9:30am Exhibit Hall Opens
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 10am TRACK 1 – Standards
Developing the CDISC Content to HL7 MessageSession ChairpersonRebecca Kush, PhDPresident and CEO, CDISC
The FDA has decided that it is time to replace SAS XPT fileswith a new method for transporting CDISC standard contentinto the FDA. The goal is to have a richly relational and hierar-chical data model that includes the meaning behind the data.This does not mean that SDTM or CDISC are going away;rather, the CDISC standards form the basis for the CDISCContent to HL7 Messages. The development of these messages
8:30 - 10am TRACK 3 – Infrastructure
Ontology Management – Data Element Repositories,Vocabulary and Terminology Services, BRIDG InformationModel, Semantic WebSession ChairpersonEric A. TateManager, Clinical Coding, Clinical Data Management,MedImmune
Learn about the scope, status and next steps of the CDISC Con-trolled Terminology project and how it relates and runs through allCDISC standards from collection (CDASH) through submission(SDTM). Update your knowledge of the CTCAE revision project,and appreciate how the NCI Center for Bioinformatics and
Information Technology is collaborating with the oncology com-munity, industry, regulators, and the MedDRA® MSSO. As well,discover how the Semantic Media Wiki platform is being used tosupport the collaborative terminology update. Identify what ismeant by each organization when upversioning MedDRA®; betterdefine the timing and scope of the update. Finally, learn how analy-sis of concomitant medications can be used to identify interactions,causes for adverse drug reactions, etc.
Controlled Terminology: Let’s Speak the Same Language!Chris TolkDirector, Terminology, CDISC
Standards Governance – Managing the Implementation ofEnterprise-wide Data StandardsDavid A. Evans, MSChief Information Officer, Octagon Research Solutions, Inc.
Streamlining and Standardizing Electronic Data Collectionfor Phase I Clinical TrialsElizabeth Nicol, MATraining/Project Manager, Genentech, Inc.
An Enterprise Scale Integrated Research PlatformDavid M. Rose, MD, MPHDirector, Clinical Sciences Informatics, Boston Cooperative StudiesProgram, Department of Veterans Affairs
continued
exemplifies the importance of collaboration among HL7 andCDISC, FDA and industry. The presentations will be followedby an extended Q&A period.
FDA Perspective on the Development of CDISC Contentto HL7 MessagesArmando Oliva, MDDeputy Director, Bioinformatics, Office of Critical Path Programs,Office of the Commissioner, FDA
CDISC Perspective on the Development of CDISCContent to HL7 MessagesDave Iberson-HurstVice President of Technical Strategy, CDISC
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10:30am - 12pm TRACK 2 – Processes
The Changing Role of Clinical Data Managers: Clinical Data Management at a CrossroadsJohann Pröve, PhDGlobal Head Data Management, Bayer Schering Pharma,Germany
Clinical data management is in a transitional situation sincemoving from the old fashioned data entry clerk and data clean-ing activities to those that not only manage the data but ratherare responsible for the standards development, eCRF design,medical coding, import and export of data and ultimately forproviding detailed status information about the trials and theprojects. This session will shed some light on the various waysof setting up the data management organizations and how thetransition phase can be managed successfully.
The Changing Role of Data ManagersErin Joy BroderickSenior Data Manager, Eliassen Group
The Changing Role of the Clinical Data Manager in aGlobalized EnvironmentJoshua CoxSenior Clinical Data CoordinatorQuintiles Transnational
Value Added by Data Management: How Could WeAchieve This?Johann Pröve, PhDGlobal Head Data Management, Bayer Schering Pharma,Germany
8:30 - 10am TRACK 3 continued – Infrastructure
Ontology Management – Data Element Repositories,Vocabulary and Terminology Services, BRIDG Information Model, Semantic Web continued
NCI Common Terminology Criteria for Adverse EventsRevision and Compliance with MedDRA®
Ann Setser, MEdNurse Consultant, Center for Bioinformatics, National CancerInstitute
A Terminology Authoring Platform Built on Semantic Media WikiSherri De Coronado, MS, MBASenior Scientist, Biomedical Informatics, NCI Center forBioinformatics and Information Technology
Harmonization of MedDRA® Versioning Between Industryand Regulators and Between Industry PartnersPatrick RevelleDirector, MedDRA® MSSO
Analysis of Concomitant Medication and Standardized Drug Queries (SDQs)Daniel von Sydow, MSc Pharm Product Manager, the Uppsala Monitoring Centre, Sweden
10 - 10:30am Refreshment Break in Exhibit Hall
10:30am-12pm TRACK 1 – Standards
ICSR and Harmonization of AE standards in BRIDGSession ChairpersonRebecca Kush, PhDPresident and CEO, CDISC
Much has been accomplished in CDISC and HL7 to addressstandards for adverse events, and there is ongoing work in thisarea. Several standards for AE reporting, from CDISC, HL7,NCI and NIH, have been harmonized within the BRIDGmodel. There is an HL7 message for reporting of post-marketingadverse event information, the Individual Case Safety Report(ICSR). And, there is now an implementation for leveraging
Electronic Health Records for safety reporting. These excitinginitiatives will be the topics for the presentations in this session.
The Individual Case Safety ReportLise StevensData Standards Project Manager, Office of the Commissioner, FDA
Leveraging Electronic Health Records for Safety ReportingMichael A. IbaraHead, Pharmacovigilance Information Management, Pfizer Inc
Parallel Tracks, Session 4
continued
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Parallel Tracks, Session 4 continued
Parallel Tracks, Session 5
12 - 1:30pm Luncheon
1:30 - 3pm TRACK 1 – Standards
Protocol – The Recipe for a Successful TrialSession ChairpersonFrank T. NewbyChief Operating Officer, CDISC
What do you need to ensure a successful trial – certainly a good product and lots of subjects. You also need good tools and processes, reliable tracking data, and the ability to use or reuse standard protocol elements. This session will provide some ideas on tools, tracking and protocol standards for your consideration.
Introduction to the CDISC-HL/7 Protocol RepresentationStandard: A BRIDG to InteroperabilityLisa Chatterjee, MSVice President, Healthcare Data StandardsDigital Infuzion, Inc.
EDC is in the Middle – The End-to-end eClinical VisionStarts with the ProtocolGlen deVries President, Medidata Solutions Worldwide
An Open-source Clinical Protocol Lifecycle Tracker (PLT)John Speakman, MSNational Cancer Institute
1:30 - 3pm TRACK 2 – Processes
Facilitating Exchange of Information with Your Third-party Vendors and PartnersSession ChairpersonsBrandon DíazSenior Project Manager, OmniComm Systems, Inc.Annette L. Mathisen, PhDSenior Director, Client Services, QST Consultations, Ltd.
This session will focus on effective team communication among sponsors and multiple vendors, resulting in 1) elimination or minimization of ambiguity and misunder-standing, 2) better management of activities and teams, and 3) increased efficiency. Tools, techniques, and examples will be presented and discussed.
Efficient Communication and Managing Third-partyVendorsMichael CloutierGeneral Manager, MedICC
Leading Virtual TeamsJosephine Scrofani, MS, CPLPVice President of Training and Consulting Eliassen Group,eClinical Solutions Division
Communication in Virtual Teams: The Vital Clinical DataLifecycle LinkMary L. MattesDirector, Global Data Management, PRA International
10:30am-12pm TRACK 3 – Infrastructure
Protecting the Integrity of Clinical Data End-to-endSession ChairpersonDenise DeRenzo Lacey, MA, MSDirector, Business Operations, Vertex Pharmaceuticals Incorporated
The speakers in this session will address the challenges involved in integration of clinical study datasets in an environment that utilizes multiple databases for collecting data. We will look at both technical and process elements of“integration,” including case studies for integrating lab data and safety data with CRF data.
Computerized Systems in Clinical Research: Current Quality and Data Integrity ConceptsStephan Klaschka, MBA, MS, MSc, PMPHead, Clinical Applications Support, Boehringer Ingelheim
Improving Your Clinical Trial through Data IntegrationPaula McHaleSenior Director, Product Management, Data ManagementSolutions, Perceptive Informatics
Leveraging EDC in the Collection of Safety DataAlastair ClewlowProduct Strategy Director of Clinical Data Management, OracleCorporation, Denmark
continued
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3:30 - 5pm TRACK 2 – Processes
Clinical Data Management Career PathsSession ChairpersonsDenise DeRenzo Lacey, MA, MSDirector, Business Operations, Vertex Pharmaceuticals Incorporated
What kind of a career can you build with a data managementbackground? In this session we’ll explore different potentialpathways. The first speaker will trace the broad range ofpossibilities for which DM training is a good fit. The other twospeakers will provide details of their careers beyond CDM.
Professional Pathways Beyond Clinical Data ManagementLynn AndersonAssociate Director, Statistical Programming, VertexPharmaceuticals
EDC Developer Career ApproachSeema Bhat, MARegional Head, EDC Operations, Bayer HealthcarePharmaceuticals
Developing a Career Path with Electronic Data CaptureRoss Rothmeier Senior Director, EDC Portfolio, Covance, Inc.
Parallel Tracks, Session 5 continued
Parallel Tracks, Session 6
1:30 - 3pm TRACK 3 – Infrastructure
Integrated Statistical Computing Environments Session ChairpersonsSue Dubman, MASenior Director, Biomedical Data Sciences and Informatics,Genzyme Corporation Daniel BoisvertPrincipal SAS Programmer, Genzyme Corporation
Unambiguous communication of results requires a transparent,reproducible, efficient and validated approach to analyzing clini-cal data. Today this is a manual process that makes it difficult fora reviewer to reproduce results. The recent advent of StatisticalComputing Environments (SCEs) provides a glimpse into thefuture; one which will introduce more automated control andadditional transparency into the statistical analysis and reportingprocess. This session will present why SCEs are needed, what isavailable, and how they can be successfully implemented.
3:30 - 5pm TRACK 1 – Clinical Data Management – Focusing on the Data
Standards Across the Healthcare Ecosystem Session ChairpersonTerry HardinPresident and CEO, PerfiTech Consulting
Pharmaceutical R&D exists in the larger environment of health-care – which is facing its own challenges in integrating data froma multiplicity of players and systems through the use of datastandards. Pharma R&D plays a role in this through such enti-
ties as HL7, but has additional opportunities to be both aprovider to, and recipient of, patient data from and for clinicaltrials and post-marketing safety surveillance. This session willdeal with how pharma companies are attempting to leverageavailable standards and information sources to reduce the current problems with information silos.
Speakers Invited
3 - 3:30pm Refreshment Break
3:30pm Exhibit Hall Closes
continued
What, Why, and How: Statistical Computing Environmentsand their Role in Completing the Electronic Clinical DataLifecycleDaniel BoisvertPrincipal SAS Programmer, Genzyme Corporation
Christopher J. ColangeloSM&RT, Statistics Modernization and Reporting Team, Eli Lillyand Company
SCE: The Current State and Needs of a Regulatory Agencyfrom a Reviewer’s PerspectiveMat SoukupMathematical Statistician, Office of Translational Sciences, CDER, FDA
CANCELLED
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3:30 - 5pm TRACK 3 – Infrastructure
Standards-based Clinical Data Repositories to SupportIntegration Across the Clinical Data LifecycleSession ChairpersonsLaurie CallenSenior Technical Manager, Clinical DataManagement, Synta Pharmaceuticals Corporation
Perspectives on Data Repositories Using SDTM, Janus and HL7Wayne R. Kubick, MBASenior Vice President Lincoln Safety Group, Phase Forward
Clinical Research Repositories as a Collaboration PlatformTim RochfordChief Technical Officer, Phase Forward
• Establish a global forum to share, evaluate and disseminate information on the processes, standards and
technologies for the management of clinical data;
• Encourage participation by professionals who are in the biopharmaceutical and healthcare industries;
• Promote education, training and career development of Clinical Data Management professionals;
• Promote multi-disciplinary collaboration and understanding;
• Increase the visibility and recognition of Clinical Data Management as a professional discipline or go to DIA’s
website www.diahome.org
Special Interest Area Communities
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
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Travel &H
otel Info
15
The most convenient airport is Philadelphia International
Airport and attendees should make airline reservations as
early as possible to ensure availability. The Marriott
Philadelphia Downtown is holding a block of rooms at
the reduced rate below until February 16, 2009, for the
DIA event attendees. Room availability at this rate is
guaranteed only until this date or until the block is
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Please contact the Marriott Philadelphia Downtown bytelephone at +1-215-625-2900 and mention the DIAevent. The hotel is located at 1201 Market Street,Philadelphia, PA 19107, USA.
Travel and Hotel
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For meeting information, contact Joanne Wallace, Program Manager at the DIA office in Horsham, PA
• FDA Update Session• Keynote Address: Ken Buetow, PhD
Associate Director for Bioinformatics and Information Technology, NationalCancer Institute, Center for Bioinformatics and Information Technology
• Tutorials: 4 tutorials will be offered on Monday, March 9.
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24th Annual DIA Data Conference and Exhibition
CLINICAL DATA LIFECYCLETrial Design through Submission and BeyondMarriott Philadelphia DowntownPhiladelphia, PA, USA
