Program Chairs Sue Dubman, MA Vice President, Information Technology and Informatics, Theravance Inc. Kristin M. Neff, MS Director of Project Management, Clinical Sciences, Boston Scientific Corp. Program Committee Paul Bleicher, MD, PhD Chairman and Founder, Phase Forward Shahla S. Farr Biostatistical Reviewer, CDER, FDA Rebecca D. Kush, PhD President and CEO, CDISC Denise DeRenzo Lacey, MA, MS Associate, Waife & Associates, Inc. Johann Pröve, PhD Global Head, Data Management Bayer Schering Pharma AG, Germany Don Rosen Principal, Don Rosen Consulting Stephen E. Wilson, DrPH, CAPT. USPHS Director, Division of Biometrics III, CDER, FDA 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 Overview Following the success of last year’s conference, this year’s conference will again feature expanded tracks and sessions on data management and eClinical topics. This conference will feature tutorials, tracks, and sessions that target both the beginner and intermediate/advanced level clinical data management professional. Other highlights will include an FDA Keynote Address, FDA Update & Town Hall Plenary Session, three Pre-conference Tutorials, and a Networking Reception. Track 1: Clinical Data Management – Focusing on the Data This track is targeted towards traditional CDMs and is designed to share best prac- tices with respect to different categories of data. Data categories include safety data, therapeutic specific data, and biomarker data. Attend this session to hear about different data management challenges and learn how others have overcome these challenges. Track 2: CDM/eClinical – Management Best Practices This track is for managers in the data man- agement and eClinical fields, as well as those seeking management roles. The ses- sions cover a wide range of topics that many managers are concerned with such as out- sourcing strategies, ensuring data quality, and mergers and acquisitions. Track 3: Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway This track focuses on a growing trend for data management to serve in a functional capacity throughout the entire clinical data pathway, from point of collection through submission to the FDA, rather than as a siloed function that delivers a clean data- base to biostatisticians. Covering topics like Statistical Computing Environments, han- dling of multiple data streams and data warehousing, this track reflects increased emphasis on ‘end to end’ data management and on managing data not as an end in itself but so that companies can interpret and turn it into intellectual property. Track 4: eClinical Technology Trends and Innovations This track is for those managers interested in effectively and appropriately applying information technology and data standards to streamline and improve the quality of clinical research processes. Topics to be explored include emerging eClinical tech- nologies and key trends in the application of eClinical technology as well as chal- lenges and opportunities in successfully adopting and implementing eClinical technologies. 23rd Annual DIA Conference and Exhibition Data Management in Transition: Putting the “e” in Data Management THIS PROGRAM WAS DEVELOPED BY THE CLINICAL DATA MANAGEMENT AND eCLINICAL SPECIAL INTEREST AREA COMMUNITIES MARCH 16-18, 2008 JW Marriott Hotel Washington, DC, USA 23RD ANNUAL DIA Exhibit Opportunity Space is available. See page 4 for contact information. Member Early-bird Register by February 25, 2008 SAVE $180 Track Descriptions
Transcript
Program ChairsSue Dubman, MAVice President, Information Technology andInformatics, Theravance Inc.
Kristin M. Neff, MSDirector of Project Management, ClinicalSciences, Boston Scientific Corp.
Program Committee
Paul Bleicher, MD, PhDChairman and Founder, Phase Forward
Shahla S. Farr Biostatistical Reviewer, CDER, FDA
Rebecca D. Kush, PhDPresident and CEO, CDISC
Denise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.
Johann Pröve, PhDGlobal Head, Data ManagementBayer Schering Pharma AG, Germany
Don RosenPrincipal, Don Rosen Consulting
Stephen E. Wilson, DrPH, CAPT. USPHSDirector, Division of Biometrics III, CDER, FDA
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 OverviewFollowing the success of last year’s conference, this year’s conference will againfeature expanded tracks and sessions on data management and eClinical topics.
This conference will feature tutorials, tracks, and sessions that target both thebeginner and intermediate/advanced level clinical data management professional.Other highlights will include an FDA Keynote Address, FDA Update & Town HallPlenary Session, three Pre-conference Tutorials, and a Networking Reception.
Track 1: Clinical Data Management –Focusing on the DataThis track is targeted towards traditionalCDMs and is designed to share best prac-tices with respect to different categories of data. Data categories include safety data,therapeutic specific data, and biomarkerdata. Attend this session to hear aboutdifferent data management challenges and learn how others have overcome thesechallenges.
Track 2: CDM/eClinical – ManagementBest PracticesThis track is for managers in the data man-agement and eClinical fields, as well asthose seeking management roles. The ses-sions cover a wide range of topics that manymanagers are concerned with such as out-sourcing strategies, ensuring data quality,and mergers and acquisitions.
Track 3: Data Management in Transition –From Keepers of Clean Data to Stewardsof the Clinical Data PathwayThis track focuses on a growing trend fordata management to serve in a functional
capacity throughout the entire clinical datapathway, from point of collection throughsubmission to the FDA, rather than as asiloed function that delivers a clean data-base to biostatisticians. Covering topics likeStatistical Computing Environments, han-dling of multiple data streams and datawarehousing, this track reflects increasedemphasis on ‘end to end’ data managementand on managing data not as an end initself but so that companies can interpretand turn it into intellectual property.
Track 4: eClinical Technology Trends and Innovations This track is for those managers interestedin effectively and appropriately applyinginformation technology and data standardsto streamline and improve the quality ofclinical research processes. Topics to beexplored include emerging eClinical tech-nologies and key trends in the applicationof eClinical technology as well as chal-lenges and opportunities in successfullyadopting and implementing eClinical technologies.
23rd Annual DIA Conference and Exhibition
Data Management inTransition: Putting the “e” in Data Management
THIS PROGRAM WAS DEVELOPED BY THE CLINICALDATA MANAGEMENT AND eCLINICAL SPECIALINTEREST AREA COMMUNITIES
MARCH 16-18, 2008JW Marriott Hotel
Washington, DC, USA
23RD ANNUAL DIA
Exhibit OpportunitySpace is available. See page 4 for contact information.
Member Early-bird
Register by February 25, 2008
SAVE $180
Track Descriptions
3 - 3:30pm Refreshment Break in the Exhibit Hall
3:30 - 5pm Parallel Tracks
5 - 6pm Networking Reception
SUNDAY, MARCH 16, 2008
7:00 - 8:30am Tutorial Registration
8:30am - 12:00pm Morning Tutorial#1 The eClinical Trial: Using the CDISC Standards as the Foundation Stone
10am - 3pm Exhibitor Registration and Booth Set-up
12 - 1:30pm Tutorial Registration
1:30 - 5pm Afternoon Tutorials#2 The CDASH Initiative: Standardized CRFs – An Idea Whose Time Has Come?#3 The EHR: A Guided Tour from the Research Perspective
4 - 6pm Attendee and Speaker Registration/Exhibit Hall Open
5 - 6pm Reception in the Exhibit Hall
MONDAY, MARCH 17, 20087:30 - 8:30am Registration and Continental Breakfast
9:00am Exhibit Hall Opens
8:30 - 9:30am Plenary Session 1: Welcome and Opening RemarksKEYNOTE ADDRESS – Janet Woodcock, MD, FDA, Modernizing Clinical Trials: A Major Critical Path Opportunity
9:30 - 10am Refreshment Break in the Exhibit Hall
10am - 12pm Plenary Session 2: FDA Update Session
12 - 1:30pm Luncheon in the Exhibit Hall
1:30 - 3pm Parallel Tracks
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Conference at a Glance
Safety Data ManagementeClinical Adverse Events Data Integration –
Safety, Speed and Accuracy
Navigating EMEA Safety Reporting toMinimize Risk and Costs: Nothing is
Standard about the Standards
The FDA Revitalization Act, Drug Safety and Data Management:
Great Expectations or Bleak House?
1 - Clinical Data ManagementThe FDA Bioresearch
Monitoring (BIMO) Initiative: Data Integrity and Quality
The FDA BIMO Initiative and the Quality of Clinical Trials Data:
A Review Perspective
An Industry Perspective on Implementing Data Quality
The Impact of Data Standards on Data Integrity and Quality
2 - CDM/eClinicalTransitioning from
Data Management to “eData Management”
Who is Managing the Data?
Large-scale Electronic Data Capture: When Size is Not the Only Issue
Electronic Data Capture (EDC) Help Desk:Metrics and Lessons Learned
eClinical Technology Trends –eClinical Futures
An Honest Look at the eClinical Process:How Biotech Can Learn from Best
Practices Outside the Industry
A Holistic Approach to Managing ClinicalData through Electronic Data Lifecycle
Management (eDLMTM)
The Next Generation of EDC Integration
Open Source Clinical Data Management
Virtually Foolproof – Managing Systems and Simulations with Virtualization
3 - Data Management in Transition 4 - eClinical Technology Trends
Management of Therapeutic DataBenefits of Online Adjudication in
Cardiovascular Research
Data Management for Medical Device Trials
Case of an Oncology Study Design Only Feasible by EDC
1 - Clinical Data ManagementProject Management Best Practices –
Making Them Work for You!What’s the Buzz in
Project Management Today?
EDC Conversion for Data Management
Tech(cli)nical Project Managers and Their Role in eCDM
2 - CDM/eClinicalChallenges and Best Practices
for Using EDCElectronic Data Capture as a Strategy to
Enhance Complete Data Capture, Site Satisfaction, and Participation inRegistries and Observational Studies
Validation of Electronic Data Capture Systems
Protocol Representation Standards,eClinical Research, and
Data ManagementProgress, Benefits and Value of an Industry
Standard for Protocol Representation
Standard Representation of Trial Design and Data Management
eXtensible Clinical Protocols:Focus on the Data Manager
3 - Data Management in Transition 4 - eClinical Technology Trends
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TUESDAY, MARCH 18, 2008
5pm Conference Adjourned
Business Transformation to Realize Value of EDC
Leading EDC Practices and ProcessImprovements to Ensure Business Benefit
Balancing the Benefits of EDC: Speed, Cost, and Quality
EDC Applications: Managing the Evolution
1 - Clinical Data ManagementOutsourcing Challenges and
Best PracticesOutsourcing Management Strategies
To Outsource or Not to Outsource? What is the Future of
Clinical Data Management?
Outsourcing: Perspective from a Niche CRO
2 - CDM/eClinicalRedefining Data Management’s
Role in EDC
Panel Discussion
Accessing Clinical TrialManagement Information from
eClinical Systems and CapabilitiesCTMS: The “S” Stands for Strategy
The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by the Inter-national Association for Continuing Education and Training (IACET), 1620 I Street, NW, Suite 615, Washington,DC 20006. The DIA has awarded up to 1.6 continuing education units (CEUs) to participants who successfullycomplete this program and tutorials.
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: .9 IACET CEUs (CEUs will not be offered for the plenary sessions.)
� Discuss how to successfully embrace emergingeClinical approaches and maximize their benefit
� Explain how to facilitate the role that data man-agement plays in an eClinical environment
� Identify opportunities and challenges in out-sourcing of data management
� Describe how to transition from traditionalClinical Data Management Systems toward anend-to-end eClinical environment
� Recognize the impact of new ways of doingresearch (like adaptive designs) on datamanagement
� Describe new techniques for monitoring andmeasuring clinical data quality and ensuringintegrity
Clinical Data Management SIACKristin M. Neff, MS, North American ChairpersonJohann Pröve, PhD, European ChairpersonDIA Contact: [email protected]
The mission of the SIAC is to:• Establish a global forum to share, evaluate and disseminate infor-
mation on the processes, standards and technologies for the man-agement of clinical data;
• Encourage participation by professionals who are in the biophar-maceutical and healthcare industries;
• Promote education, training and career development of ClinicalData 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 websitewww.diahome.org
Special Interest Area Communities
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
Learning ObjectivesAt the conclusion of this conference, participantsshould be able to:
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Exhibit information
Exhibitor Information
Exhibitors (as of January 28, 2008)
ICON plcINC ResearchKestrel Consultants, Inc.Kforce Clinical Research StaffingLogos Technologies, Inc.MedFocus, LLCMedidata Solutions WorldwideOctagon Research Solutions, Inc.OmniComm Systems, Inc.
Almac Clinical TechnologiesApplied Clinical TrialsAverion International Corp.C3i, Inc. ClinPhoneClinsys Clinical Research, Inc.Eliassen GroupeResearchTechnology, Inc.Fast Track Systems, Inc.
Phase ForwardRPS, Inc.StrataTAKE Solutionsthe Uppsala Monitoring CentreTrialStat CorporationVIASYS Clinical ServicesWaban Software, Inc.XClinical GmbHXTrials Research Services
Exhibit Hall HoursSunday, March 16 4 - 6pmThere will be an opening reception in the exhibit hall from 5 - 6pm.
Monday, March 17 9am - 6pmNetworking Reception from 5 - 6pm.
Tuesday, March 18 9:30am - 3:30pm
Coffee breaks & receptions will be held in the exhibit hall.
For more information, contact:Erin Gilliland, Exhibits Associate telephone +1-215-442-6149email [email protected]
Sunday, March 16, 2008 10am - 3pm – Exhibitor Registration and Booth Set-up
Sunday, March 16, 2008 (Tutorials Only)
7 - 8:30am Tutorial Registration
8:30am - 12pm Tutorial 1
#1 The eClinical Trial: Using the CDISC Standards asthe Foundation Stone(.3 IACET CEUs)
InstructorDavid P. Iberson-HurstVice President of Technical Strategy, CDISC
OverviewThis tutorial will advance participants who are novices regardingCDISC and its standards to a position of understanding howthe main CDISC standards – the Operational Data Model(ODM), the Study Data Tabulation Model (SDTM), AnalysisData Model (ADaM) and the Laboratory Model (LAB) -combine with the emerging standards such as CDASH andProtocol to provide industry with an end-to-end solutionfocused on moving data from the point of capture to submis-sion and subsequent long-term archive.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:
� Outline the basics concepts behind the production SDTM,ODM, define.xml, LAB and ADaM standards as well as theemerging protocol and CDASH standards
� Describe the CDISC standards and their value to eClinicaltrials
� Discuss how data flows, using the CDISC standards, fromclinician to submission
� Describe how to leverage the standards to improve regulatorycompliance
Target Audience: This tutorial is designed for anyone who isinvolved in implementing new technologies and/or data stan-dards to streamline clinical trials, especially project managers,CRAs, data managers and those involved in managing or imple-menting trials across departments.
10am - 3pm Exhibitor Registration and Set-up
12 - 1:30pm Luncheon Break (Lunch is not served on tutorial day)
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1:30 - 5pm Concurrent Tutorial 2
12 - 1:30pm Tutorial Registration
#2 The CDASH Initiative: Standardized CRFs – An Idea Whose Time Has Come?(.3 IACET CEUs)
OverviewStandardization of basic data collection fields for clinical research will result in greater efficiencies among sponsors, inves-tigators and research sites, facilitating more efficient monitoring,auditing, regulatory submission and review procedures. TheClinical Data Acquisition Standards Harmonization (CDASH)initiative is led by CDISC with strategic input and support froma collaborative group of various stakeholder organizations as anFDA Critical Path Initiative Opportunity. This tutorial willdiscuss the benefits of standardization, the history, process andstatus of the CDASH initiative.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Describe how CRF standardization can benefit investigative
sites and other stakeholders in the clinical research enterprise� Summarize the CDISC Standards Development Process, how
CDASH is following this process and the status and next stepsof the initiative
� Discuss how the CDASH project data collection fields fit inwith other CDISC standards (SDTM, Terminology) as well asother key collaborations
� Explain how CDASH data collection elements can be used tocreate XML style sheets (style sheets)
� Describe how CDASH, combined with an integrated profilecan facilitate interoperability, in particular clinical researchusing EHRs
Target Audience:This tutorial is designed for anyone who is involved in improv-ing clinical research processes, implementing new technologiesand/or data standards to streamline clinical trials, especially projectmanagers, CRAs, study coordinators, data managers and thoseinvolved in managing or implementing trials across departments orat investigative sites or academic research centers.
4 - 6pm Registration (Attendees and Speakers) and Exhibit Hall Opens
5 - 6pm Reception in the Exhibit Hall
1:30 - 5pm Concurrent Tutorial 3
#3 The EHR: A Guided Tour from the ResearchPerspective(.3 IACET CEUs)
InstructorMark Hoffman, PhDDirector, Translational Medicine
OverviewThe potential of clinical data to support clinical research is wide-ly appreciated and has been the subject of many demonstrationprojects. Key to success in expanding these efforts is extraction of meaningful information from electronic health record (EHR)systems, while working within the constraints of applicable pri-vacy policies. This tutorial will provide a detailed discussionabout the structure of EHR systems, the diversity of data avail-able within EHR systems and the methods available for integrat-ing research and patient care activities. This session will also iden-tify some of the practical challenges encountered during efforts to use EHR systems to support research.
Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Define the components of commercial EHR systems� Explain the significance of EHR design decisions for research� Discuss the future involvement of EHR systems in supporting
pharmaceutical research
Target Audience:Any person with a research, clinical or technical background andan interest in the use of clinical data as a resource for research.
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 9:30amWelcome and Opening Remarks from Program ChairpersonsSue Dubman, MA Kristin M. Neff, MSVice President, Information Technology and Informatics, Director of Project Management, Clinical Sciences, Theravance Inc. Boston Scientific Corp.
Keynote AddressModernizing Clinical Trials: A Major Critical Path OpportunityJanet Woodcock, MDDeputy Commissioner and Chief Medical Officer, FDA
10am - 12pm Plenary Session 2
Pushing for eHealth and eScience: An FDA Update
9:30 - 10am Refreshment Break in the Exhibit Hall
The “Food and Drug Administration Amendments Act of 2007”is the law of the land, PDUFA IV is a reality and Critical Pathopportunities are shaping new directions for product development,science and regulation. The push is on to simultaneously expeditedrug development and the process for the review of human drugapplications. Whether it’s decisions regarding safety, efficacy, bene-fit-risk, risk management, biomarkers, risk communication, or anyof the countless questions that are addressed by the Agency, weneed to take action efficiently and effectively. To make this hap-pen, the Agency is continuing the push for an all-electronic worldof healthcare, clinical trials, application submission and review.
The FDA panel members for this session are deeply involved andhelping us all work towards this new electronic world. They willshare their views on a large number of Agency initiatives andprograms: standards development with HL7 and CDISC; theCDASH project that is pushing to streamline clinical trials; an
ODM Pilot that will make data management and monitoringmore transparent; the Agency’s electronic platform; the push to enhance and standardize safety reporting with ICSR andMedwatch; efforts to assure compliance as we vigorously moveto electronic data capture; progress in the submission ofSDTM and ADaM data for review; our attempts to influenceand encourage electronic health records; the new developmentsand directions in the building Janus; and much more.
What is the vision? How are we going to get there? How doesall of this affect you? This is a “need-to-know” opportunity fordata management and eClinical professionals to listen, to hearthe latest, to learn and to be partners in this important processand dialogue – please bring your knowledge, your problems,your questions, and your solutions to this FDA update/townhall session!
Session ChairpersonKim W. Nitahara, MBAPrinciple Consultant, META Solutions, Inc.
PanelistsJonathan G. LevineMathematical Statistician, Office of Pharmacoepidemiologyand Statistical Science, CDER, FDA
The FDA Bioresearch Monitoring (BIMO) Initiative: Data Integrity and QualitySession ChairpersonsRebecca D. Kush, PhDPresident and CEO, CDISCRepresentative InvitedCDER, FDA
Clinical research is becoming increasingly global and there is acorresponding interest in applying new technologies to stream-line data collection, exchange, analysis and reporting. The cur-rent methods for monitoring and managing data and data qual-ity are outdated and not scalable to the necessary level. TheFDA announced, in June 2006, its BIMO Initiative to specifi-cally address concerns around the protection of human subjectsand the integrity of data in clinical trials. A DIA workshop washeld in May 2007 on the topic of “Designing and Implement-ing Quality in Clinical Investigations from Design toCompletion”. This session will draw from that workshop toprovide a summary of the BIMO Initiative, exploring specific-ally how this relates to Data Management and Data Standards.
The FDA BIMO Initiative and the Quality of Clinical TrialsData: A Review PerspectiveRepresentative InvitedCDER, FDA
An Industry Perspective on Implementing Data QualityRoland UsherDirector, Research Quality Assurance, Eli Lilly and Company
The Impact of Data Standards on Data Integrity and QualityRebecca D. Kush, PhDPresident and CEO, CDISC
1:30 - 3pm TRACK 1 – Clinical Data Management – Focusing on the Data
Safety Data ManagementSession ChairJohann Pröve, PhDGlobal Head, Data Management, Bayer Schering PharmaAG, Germany
This session will address several aspects of the safetyreporting and the regulations impacting Clinical DataManagement.
eClinical Adverse Events Data Integration – Safety, Speed andAccuracyChristine Lys, MSDirector, Scientific Affairs and Business Development, etrials, Inc.
Navigating EMEA Safety Reporting to Minimize Risk andCosts: Nothing is Standard about the StandardsAlison TaberExecutive Director, Data Management, INC Research
The FDA Revitalization Act, Drug Safety and DataManagement: Great Expectations or Bleak House?Barton Cobert, MDVice President, Global Regulatory Initiatives and Pharmacovigilance,Medidata Solutions
Technological advances serve either to disrupt or complementthe way clinical research is conducted. This session will serve asa forum for presenting emerging technologies, evaluate thechances of their adoption and discuss the effect they may haveon the processes and systems we currently employ. Following ashort presentation by each speaker of a specific topic related tothe future of clinical research, a panel discussion and dialogamong the speakers and attendees will further explore the futureimpact of technology on the clinical trial process.
An Honest Look at the eClinical Process: How Biotech Can Learn from Best Practices Outside the IndustryNick LucasVice President, Data Services, Europe, INC Research, UK
A Holistic Approach to Managing Clinical Data throughElectronic Data Lifecycle Management (eDLM™)Peg ReganPresident and CEO, PharmaPros Corp.
The Next Generation of EDC IntegrationDavid B. SteinVice President, Product Management, ClinPhone, Inc.
Open Source Clinical Data ManagementR. Mark Adams, MDProject Manager, NCI’s Cancer Biomedical Informatics Grid;Senior Associate, Booz Allen Hamilton
Virtually Foolproof – Managing Systems and Simulationswith VirtualizationDan ShookowskyTechnical Manager, Almac Clinical Technologies
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3:30 - 5pm TRACK 1 – Clinical Data Management – Focusing on the Data
Management of Therapeutic DataSession ChairpersonEve-Marie Whitsun-JonesAssociate, Waife & Associates Inc.
This session will highlight best practices for capturing andmanaging specialized therapeutic clinical data and will alsodescribe how electronic data capture technology can addresssome of the challenges faced by these unique clinical datascenarios.
Benefits of Online Adjudication in Cardiovascular Research Vincent CabaneClinical Director, Kika Medical, France
Data Management for Medical Device TrialsReza RostamiManager, Clinical Data Operations, Clinical Data Integration,Duke Clinical Research Institute
Case of an Oncology Study Design Only Feasible by EDCDavid PauSenior Clinical Data Manager, Roche, France
1:30 - 3pm TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Transitioning from Data Management to “eDataManagement”Session ChairpersonDenise Lacey, MA, MS Associate, Waife & Associates, Inc.
In this session, we will explore the impact on Data Managementwhen the majority of clinical studies transition from paper toelectronic data capture (EDC). We will focus on changes totraditional Data Management roles and responsibilities as wellas new tasks that sometimes fall under Data Management’sdomain as a result of EDC restructuring.
Who is Managing the Data?Denise Lacey, MA, MS Associate, Waife & Associates, Inc.
Large-scale Electronic Data Capture: When Size is Not the Only IssueNicolas Schaltenbrand, PhDSenior Director, Global Data Management, Quintiles, France
Electronic Data Capture (EDC) Help Desk: Metrics andLessons LearnedAndy MacKelfreshClinical Data Systems Analyst, Duke Clinical Research Institute
Protocol Representation Standards, eClinical Research,and Data ManagementSession ChairpersonRebecca D. Kush, PhDPresident and CEO, CDISC
An industry standard for representing the protocol as a struc-tured document holds the promise of significant value for awide range of protocol-driven research studies, from stream-lining processes to improving quality. This session will explorethe benefits and value of such a standard and progress to datethrough the efforts of a joint HL7-CDISC Protocol Represen-tation Group with a charter to develop a standard for a machine-readable protocol. Specifically, there will be a presentation onthe Trial Design Model, which is also a part of the Study DataTabulation Model (SDTM), and how this model can helpautomate creation of data collection tools and databases andimprove tracking of planned vs. actual visits and treatment.
There will also be a presentation on the creation of eXtensibleClinical Protocols using XML and the opportunities and chal-lenges these afford for two-way communication between thestudy design (protocol) and data capture systems.
Progress, Benefits and Value of an Industry Standard forProtocol RepresentationHelle-Mai Gawrylewski, MADirector, Medical Writing, Medical Knowledge Management,Johnson & Johnson PRD
Standard Representation of Trial Design and DataManagementDiane E. Wold, PhDDirector, Data Standards, GlaxoSmithKline
eXtensible Clinical Protocols: Focus on the Data ManagerFredric J. Cohen, PhDVice President, Clinical Strategy, Fast Track Systems
Project Management Best Practices – Making Them Work for You!Session ChairpersonKristin M. Neff, MSDirector of Project Management, Clinical Sciences, Boston Scientific Corp.
Project Management has long been recognized as a set of tools andbehaviors that are valuable in improving a team’s ability to achievetheir objectives. In the increasingly complicated Clinical DataManagement function, good project management practices havebeen applied with great success. This session will begin by sharingsome current project management best practices with practical rec-ommendations you can take back to your projects. Then two spe-cific applications of project management will be presented. The
first presentation focuses on using project management practices toadopt multiple EDC technologies. The second presentation willintroduce the concept of Tech(cli)nical Project Managers.
What’s the Buzz in Project Management Today?Kristin M. Neff, MSDirector of Project Management, Clinical Sciences, Boston Scientific Corp.
EDC Conversion for Data ManagementColleen C. LockwoodProject Management, Omnicomm Systems
Tech(cli)nical Project Managers and Their Role in eCDMSuresh Sharma
3:30 - 5pm TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Challenges and Best Practices for Using EDC Session ChairpersonMarc PennaMedidata
This session will focus on the challenges associated withutilizing an Electronic Data Capture system and those bestpractices that can be used to avoid those challenges all together.We will discuss a number of areas related to the use of EDCincluding site satisfaction, completeness of data, validation, and Part 11 compliance.
Electronic Data Capture as a Strategy to Enhance Complete Data Capture, Site Satisfaction, and Participation in Registries and Observational StudiesEunice Franklin-Becker, MPHProject Manager, Covance Periapproval ServicesSarah A. WiseProject Manager, Covance Periapproval Services
Validation of Electronic Data Capture SystemsWyetta PalmbyConsultant, Pharmasys
Outsourcing Challenges and Best PracticesSession ChairpersonSue Dubman, MAVice President, Information Technology and Informatics,Theravance Inc.
Making use of external partners such as Contract ResearchOrganizations (CROs) and outsourced Clinical Data Man-agement (CDM) Centers is a way of life today for many bio-pharmaceutical companies and can help expedite the drugdevelopment process and allow biopharmaceutical companies to focus on their core competencies. That said, if not managedproperly, costs can spiral out of control and/or there can bequality and compliance issues. This session will discuss the pros and cons of outsourcing all, as well as portions of, clinicalresearch activities. It will also address the factors critical to thesuccess of external partner relationships from both the CROand Sponsor perspective, including approaches to proactivelymanaging and minimizing risks and how to avoid pitfalls.
Outsourcing Management StrategiesSue Dubman, MAVice President, Information Technology and Informatics,Theravance Inc.
To Outsource or Not to Outsource? What is the Future of Clinical Data Management?Robert J. MustererDirector, Clinical Systems, Bayer HealthCare
Outsourcing Strategies-Transforming Your CRORelationshipsMichael BreggarDirector, Life Sciences Consulting Practice, Strategy andOperations, Performance Improvment, Deloitte
Tuesday, March 18, 2008 Parallel Tracks
9:30am Exhibit Hall Opens
7:30 - 8:30am Registration and Continental Breakfast
8:30 - 10am TRACK 1 – Clinical Data Management – Focusing on the Data
Business Transformation to Realize Value of EDCSession ChairpersonKen Light, MSSenior Vice President, Professional Services, OmniComm Systems, Inc.
The fundamental benefits of eCRFs and paperless trials (reducedtime and improved data quality) will never be fully realized with-out a parallel change in business processes and organizationalstrategy. This session will identify and present those leadingindustry practices, experiences and recommendations, to helpensure that organizations fully leverage their investment in EDC technologies. Organizations that advocate business trans-formation and adoption of best practices will be seen as leaders in achieving clinical excellence.
Leading EDC Practices and Process Improvements toEnsure Business BenefitKen Light, MSSenior Vice President, Professional Services, OmniComm Systems, Inc.
Balancing the Benefits of EDC: Speed, Cost, andQualitySondra Smyrnios, MScCEO, Evia Clinical Services, LLC
EDC Applications: Managing the EvolutionDaryl MatthewsClinical Data Associate, Gilead Sciences
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10:30am-12pm TRACK 1 – Clinical Data Management – Focusing on the Data
Managing ‘Omics’ Data in Clinical Trials: InformaticsSolutions to Empower Biomarker Data ManagementSession ChairpersonSubha Madhavan, PhD Associate Director, Integrative Cancer Research Products and Programs,NCI, Center for Biomedical Informatics and Information Technology
The vision for overcoming cancer lies in the promise of themolecular age and the era of individualized, targeted preventionand care tailored to a specific patient. To achieve this vision,studies must provide access to data from very diverse sourcesand analyses by multi-disciplinary teams. The level of integra-tion, collaboration, and coordination required to meet theseneeds has been and continues to be very challenging; however,there are new efforts beginning to address these challenges. Real-world examples, focused on biomarker research, are presented inthis session to demonstrate the use of data standards and inte-grative informatics platforms to support the management ofmolecular data in clinical trials.
Informatics Solutions to Empower Translation ResearchSubha Madhavan, PhD Associate Director, Integrative Cancer Research Products andPrograms, NCI, Center for Biomedical Informatics andInformation Technology
Information Management Challenges in I-SPY Neo-adjuvant Breast Cancer TrialLaura Esserman, MD, MBADirector, Carol Franc Buck Breast Care Center, Professor ofSurgery and Radiology
Challenges in Biomarker Research: Study Design, Clinical Realities, and Informatics – The Inter-SPOREProstate Biomarkers StudyBruce J. Trock, PhDAssociate Professor of Urology, Epidemiology, Oncology; Director,Division of Epidemiology, Johns Hopkins Medical Institutions
8:30 - 10am TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Redefining Data Management’s Role in EDCSession ChairpersonMichael BurtonDirector, eClinical Solutions, Omnicare Clinical Research
This will be a panel discussion of CRO, consultant and pharmapersonnel on the necessary role shifts between clinical datamanagement and monitoring in order to achieve efficiency withelectronic data capture. Topics of discussion will include roles andresponsibilities for ongoing data review, query generation/resolu-tion confirmation and communication with site personnel as wellas the impact of source document verification on data review.
PANELTim DietlinVice President, Campbell AllianceLori BacaDirector, Clinical Data Management, AmgenKelly VaillantExecutive Director, Clinical Data Management, NovartisRobert CriscolaAssociate Director, Data Management, Indevus Pharmaceuticals, Inc. Casey HigginsDirector, CDM Study Initiation, Omnicare Clinical Research
8:30-10am TRACK 4 – eClinical Technology Trends and Innovations
Accessing Clinical Trial Management Information fromeClinical Systems and CapabilitiesSession ChairpersonPaul Bleicher, MD, PhDChairman and Founder, Phase Forward
Traditional CTMS systems often rely on separate, redundantdata entry for operational information and metrics. The arrivalof EDC has made it possible to collect high quality, timely dataabout clinical trials, and allows this data to be used for manage-ment of trial milestones and operations. Operational data fromEDC systems can provide information about quality, efficiency,and timeliness of clinical operations, and provide benchmarksand comparisons of operations between teams and programs.
This session will examine some of the ways that CTMS func-tionality is being incorporated into EDC solutions and how datafrom EDC systems is integrated with existing CTMS systems.
CTMS: The “S” Stands for StrategyLeslie Bihari, Jr.President, eClipse Professional Services, LLC
Managing Clinical Trials through Technology IntegrationMark SonenblickManager, IVRS Services, PharmaNet
Lora E. ToddManager, Global System Delivery, Phase Forward
10 - 10:30am Refreshment Break in Exhibit Hall
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10:30am-12pm TRACK 4 – eClinical Technology Trends and Innovations
ePRO Best PracticesSession ChairpersonDenise Lacey, MA, MSAssociate, Waife & Associates, Inc.
This session will move beyond ePRO implementation to ePRObest practices, with experienced speakers presenting their lessonslearned.
ePro: My JourneySuzanne L. LamerandVice President, Clinical Data Management, DSG, Inc.
Challenges and Best Practices for Using Tablet-based ePROin Multinational Clinical Trials Joy HebertCOO, assisTek
Collecting ePRO Data for Clinical Research: OperationsNightmare or Routine Work?Curtis P. CampbellClinical Data Operations Manager, Duke Clinical ResearchInstitute (DCRI)Lori PooleAssistant Director, Clinical Data Operations, Duke ClinicalResearch Institute (DCRI)
12 - 1:30pm Luncheon
Parallel Tracks, continued
10:30am-12pm TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Statistical Computing Environments: Collaboration throughMetadata, People, Process, and SoftwareSession ChairpersonSusan P. Duke, MApStat, MS Assistant Director, Biostats and Programming Development Partners GlaxoSmithKline
This session will discuss the need to manage clinical data in Statis-tical Computing Environments. With the advent of new FDARegulatory/Guidelines, new standards, increasing technology com-plexity and the increasing cost of validation needed to managecomplex data and processes, Statistical Computing Environments(SCE) have become a necessary tool to increase productivity andquality. If done right, an SCE implementation will provide repro-ducible research, transparent and efficient processes, validatedanalysis, and data integrity assurance. Successfully implementinginnovative solutions, like SCE, however, means addressing boththe technical and nontechnical (people-process-cultural) challenges.
Implementation Metadata: Describing Lilly’s ExperienceWith Modernizing our Medical Information SystemChristopher Colangelo, MSPHAssociate Senior Statistician, Business Lead for SDD Implementa-tion and Migration of Legacy Data, Eli Lilly and Company
The User’s View: Defining, Evaluating and Implementing a Statistical Computing EnvironmentLinda CollinsConsultant, Statistical Software and Services, PharmaStat LLC
Metadata Management in a Statistical ComputingEnvironmentDana SoloffDirector, Statistical Programming, Biomedical Operations,Genzyme CorporationDan BoisvertPrinciple Programmer Analyst, Genzyme Corporation
10:30am-12pm TRACK 2 – CDM/eClinical – Management Best Practices
Mergers and Acquisitions: The Impact on Clinical DataManagement Session ChairpersonJohann Pröve, PhDGlobal Head, Data Management, Bayer Schering Pharma AG,Germany
This session will address some of the challenges associated with the merger and/or acquisition of two pharma companies,the impact on the people, the tools selected and the standards development.
An Up-front, Multidisciplinary Approach to Data StandardsCarol A. McKennaAssociate Director, Clinical Data Management, Biogen Idec
The Impact of the Merger of Merck and Serono on theDM StaffStephane MarzabalHead, Clinical Data Management, Merck Serono, Switzerland
Integration of the DM Tools at Bayer Schering PharmaDuring the MergerJohann Pröve, PhDGlobal Head, Data Management, Bayer Schering Pharma AG,Germany
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1:30 - 3pm TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Handling Multiple Data Streams for Clinical TrialsSession ChairpersonDenise Lacey, MA, MS,Associate, Waife & Associates, Inc.
In today’s complex research environment, data captured inmultiple systems – IVRS, LIMS, EDC, ePRO, CDMS, variousimaging tools – must be received, handled, and reconciled. Inthis session, each speaker will focus on a different data stream(lab data, EDC data, and IVRS/IWRS, respectively) and discussstrategies for handling and reconciling data successfully, as wellas integration with other data streams.
Niche Data Managers: Necessary Qualities for eDataManagement SuccessValerie BonannoDirector of Laboratory Data Operations, BLCPro
A Complex Protocol Design to Accelerate Clinical Trials:How to Implement Multiple Database Lock in an Electronic Data Capture SystemVadim TantsyuraAssociated Director, Data Management, RegeneronPharmaceuticals, Inc.
Accelerating IVRS/IWRS Deployment and Making it Work for Your Study TeamsPaulette V. Roper, MSProject Leader, eSolutions, Allergan Inc.
1:30 - 3pm TRACK 1 – Clinical Data Management – Focusing on the Data
Coding and PharmacovigilanceSession ChairpersonJohann Pröve, PhDGlobal Head, Data Management, Bayer Schering Pharma AG,Germany
This session will provide some insight into the adverse eventscoding processes as well as addressing the potential use ofMedDRA in the analysis of adverse events data via StandardisedMedDRA Queries.
Medical Coding in Adverse Event Processing PathwaySonja Brajovic, MDMedical Manager, PSI International
Standardised MedDRA Queries: An OverviewJudy E. Harrison, MDMedical Officer, MedDRA MSSO
MedDRA as a Standard: Approach to Version Updates andPrimary SOC AllocationPatricia Mozzicato, MDChief Medical Officer, MedDRA MSSO
Increasing Efficiency and Collaboration through SecureShared ServicesSession ChairpersonSue Dubman, MAVice President, Information Technology and Informatics, Theravance, Inc.
This session is intended to discuss the incentives and opportun-ities for researchers to use shared, emerging technologies andsolutions to improve quality and efficiency in data managementand analysis for clinical research and post marketing data sources.Shared research services can reduce individual investments, accel-erate innovation through focused and shared investment whilepresenting new opportunities for collaboration and team support.The session will discuss how a properly governed, secured, costeffective and widely available collaboration capability can provideinroads to clinical data exchange and collaboration.
Business/Research Value of a Shared CollaborationPlatformLaura Esserman, MD, MBADirector, Carol Franc Buck Breast Care Center, Professor ofSurgery and Radiology
The Foundation of a Collaboration PlatformMark VermetteProduct Manager, CRIX International
Governance of a Shared PlatformJames Bland, MBAExecutive Director, CRIX International
CDM without Traditional Clinical Data ManagementSystemsSession ChairpersonPaul Bleicher, MD, PhDChairman and Founder, Phase Forward
As EDC adoption continues, large and small companies alikeare rethinking their strategies regarding data management.Many organizations now go directly from EDC to data analysis,skipping traditional data management systems. Some are alsolooking to open data repository and data warehouse strategies tomaximize the value of their clinical trial data assets. This sessionwill explore real-world experience with these systems, and willexamine their implications for the future.
Living without a Clinical Data Management SystemKeith L. HowellsVice President, Development, Medidata Solutions, Inc.
EDC Data Extracts without a CDMS – One Company’sApproachPaul Bukowiec, MSDirector, Statistical Programming, Millennium PharmaceuticalsSteve Wong, MSAssociate Director, Statistical Programming, MillenniumPharmaceuticals
3:30 - 5pm TRACK 1 – Clinical Data Management – Focusing on the Data
Sequential Adaptive Design Considerations inObservational Studies and RegistriesSession ChairpersonSean D. Kennedy, MPHDirector, Registries and Observational Studies, CovancePeriapproval Services
The purpose of this session is to address the use of SequentialAdaptive Methodology in the conduct of Phase IV programs,Observational Studies, and Registries with a specific discussionon the impact to Data Management. Presentation of case studiesand real-world examples will enhance the following learningobjectives: how Adaptive Design is easily applicable to observa-tional programs and registries; challenges handling retrospective
data and site re-training needs as a result of implementingAdaptive Design changes; demonstrated improvements in dataquality and site efficiency as a result of Adaptive change; under-standing appropriate ways to implement a Sequential Adaptivestrategy without adding bias and variance; and expanding aware-ness of Sequential Adaptive Study Design and providing a forumfor consistent application throughout the industry.
Richard PiazzaVice President, New Products, Medidata Solutions Worldwide
Eva R. Miller, PhDHead of Biostatistics, ALMAC Clinical Technologies
Michael J. HillSenior Registry Associate, Covance Periapproval Services
Data Standards: What Are They Good for?Session ChairpersonDon RosenPrincipal, Don Rosen Consulting
eClinical professionals love standards – that’s why there are somany of them. This session will explore the current state ofrelevant clinical data standards, and provide some input on how they can be used to facilitate the management of theclinical development information value chain.
The Landscape of Standards: Making Sense of the Alphabet SoupKit HowardPrincipal and Owner, Kestrel Consultants, Inc.
SDTM – Plus or Minus?Barry R. CohenDirector, Clinical Data Strategies, Octagon Research Solutions
Integrated Database and CRF DevelopmentAndy Richardson, PhDADH Solutions Ltd.
Implementing Standards: The Evolving Roadmap forIntegrating Patient Care and Clinical Research DataSession ChairpersonCharles Jaffe, MD, PhDCEO, Health Level 7, Inc.
Although importing health record information into an elec-tronic data capture system is a useful first step, it falls short of bringing data from the bench to bedside and back again.With the development of unified data standards and the adop-tion of structured vocabularies, true data sharing is possible.This will require cooperation at a policy level as well as from a technical perspective. Opportunities are now being nurturedto make both of these goals a reality.
Connecting Two Worlds: Electronic Health Record Systems and Clinical ResearchLinda King, MT(ASCP)Data Management Team Leader, Center for Process Expertise, Eli Lilly and Company
Speakers invited
5pm Conference Adjourned
The most convenient airport is Reagan National Airport and attendees shouldmake airline reservations as early as possible to ensure availability. The JWMarriott Hotel is holding a block of rooms at the reduced rate below untilFebruary 22, 2008, for the DIA event attendees. Room availability at thisrate is guaranteed only until this date or until the block is filled.
Single $289 Double $289
Please contact the JW Marriott Hotel by telephone at +1-800-228-9290or +1-202-393-2000 and mention the DIA event.
The hotel is located at 1331 Pennsylvania Avenue NW, Washington,DC 20004, USA.
TRAVEL AND HOTEL
Parallel Tracks, continued
3:30 - 5pm TRACK 3 – Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
Data Warehousing Concepts for CDISC SDTM DataSession ChairpersonStephen J. Kopko, MSSenior Director, Biostatistics Systems Development, Wyeth Research
As sponsor organizations generate clinical information in theon-going clinical research process, they must determine theoverall objective for the information, namely regulatory sub-mission needs. The FDA is currently requesting the submis-sion of the SDTM-compliant data as part of the eCTDSubmission process for use in the submission review processand ultimate upload to the JANUS data warehouse. Sponsororganizations have taken a number of different approaches on the development and implementation of SDTM data basedon a number of “white papers” describing potential approaches.This session will focus on the architectural, technological andprocess aspects of designing, developing and implementingcomplex, SDTM related clinical data warehouses. The goal ofthese clinical data warehouses is to support the compliance
with the CDISC SDTM standards and integration of theirdata management and statistical analysis practices with theconsolidated and compliant data. Another need for these datawarehouses is to share and create integrated databases forAlliance partnerships. The speakers will each present their own concepts and models for accomplishing this vision and the level of effort and resources that have been required toimplement this concept within their own organization. Thespeakers will consists of individuals from Pharma/Biotech and clinical research organizations that currently have SDTM-related data warehouses active or underway.
Metadata Repository Use in an End-to-end, CDISCStandards-based Clinical Data LifecycleBarry Cohen, MSDirector, Clinical Data Strategies, Octagon Research SolutionsStephen J. Kopko, MSSenior Director, Biostatistics Systems Development, Wyeth Research
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Drug Information Association www.diahome.org
• 4 Parallel Tracks: Clinical Data Management — Focusing on the Data
CDM/eClinical — Management Best Practices
Data Management in Transition – From Keepers of Clean Data to Stewards of the Clinical Data Pathway
eClinical Technology Trends and Innovations
• FDA Update Session
• Keynote Address: Janet Woodcock, MD, FDA
• Tutorials: 3 tutorials will be offered on Sunday, March 16.
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Tutorials
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23rd Annual DIA CLINICAL DATA MANAGEMENT Conference and ExhibitionData Management in Transition: Putting the “e” in Data Management
March 16-18, 2008 | JW Marriott Hotel, Washington, DC, USA
GROUP DISCOUNTSRegister 3 individuals from the same company and receive complimentary registration for a 4th! All 4individuals must register and prepay at the same time – no exceptions. DIA will apply the value of thelowest applicable fee to this complimentary registration; it does NOT include fees for optional events orDIA membership. You may substitute group participants of the same membership status at any time;however, administrative fees may be incurred. Group registration is not available online and does notapply to the already-discounted fees for government or charitable nonprofit/academia.
Please make a copy of this registration form for EACH of the four group registrants. Include the namesof all four group registrants on each of the forms and return them together to DIA.
