Symposium and Exhibition Delivering Quality Data ... · CDM • March 26-29, 2006 • Philadelphia...

Program CommitteeB. Sue Bell, PhDFDA

Colleen M. Cox, CCDMPROMETRIKA

Ronald D. Fitzmartin, PhD, MBADaiichi Medical Research, Inc.

Jonathan Haddad, MT (ASCP), MPHSynta Pharmaceuticals Corp.

Denise DeRenzo Lacey, MA, MSWaife & Associates, Inc.

Chris A. LeGrand, MSConstella Group, Inc.

Johann Pröve, PhDBayer Vital GmbH, Germany

Karen K. UnderkoflerClinical Data Management SAIC

Stephen E. Wilson, DrPHFDA

Target AudienceThis conference welcomes all levels of clinicaldata management professionals, from the begin-ners to the seasoned experts. We also encourageanyone who has an interest in clinical datamanagement or works closely with clinical datamanagement to attend and participate. Ourgoal is to attract a wide spectrum of attendeeswho can contribute to the breadth and depth ofthe meeting.

Online Registration is Available! www.diahome.org Monitor the website for the most current details.DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: [email protected]

THIS PROGRAM WAS DEVELOPED BY THE CLINICAL DATA MANAGEMENT SPECIAL INTEREST AREA COMMUNITY

Learning Objectives� Describe what’s new in Data

Management, from eCRF designthrough most effective organizationalstructures to the latest in validation

� Apply best practices for managingData Managers – what works andwhat doesn’t work

� Demonstrate how to manage changeeffectively within a DataManagement organization

� Summarize ways to prepare for andsurvive a Quality Audit

� Describe what being a Global DataManagement organization reallymeans

� Outline ways to improve workingrelationships with colleagues inClinical, Stats, etc.

� Apply technology to the DataManagement Infrastructure

� Discuss hot topics in coding

� Understand the practical implica-tions of implementing CDISC

� Optimize training for DataManagers

Delivering Quality Data Effectively in a Changing Environment!

21st Annual DIACLINICAL DATA MANAGEMENTSymposium and Exhibition

Program ChairpersonKristin M. Neff, MSBoston Scientific Corp.

BONUS OFFERING!

Attend two meetings for

the price of one!

See page 3 for details.

MARCH 26–29, 2006Philadelphia Marriott

Downtown1201 Market Street

PHILADELPHIA, PA, USA

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Ove

rvie

w

2

OverviewPlease join us in celebrating the 21styear of this hallmark meeting.

We have taken a fresh approach to thisyear’s meeting and are presenting a com-bination of new topics along with someof our ever-popular standard DataManagement topics. The conference isorganized in three parallel tracks:

Data Management FundamentalsManaging Data ManagementData Management – OtherPerspectives

Data Management Fundamentals willcover many popular Data Managementtopics including validation, eCRF designand coding.

Managing Data Management is a newtrack. A wide range of management topics

will be presented such as the optimalorganization structures for data manage-ment organizations and current trends intraining data managers. We have evenincluded a special session on managingchange – something that continues toaffect many of us!

Finally, we are offering a Data Manage-ment – Other Perspectives track. In thistrack, sessions will explore topics whichare not strictly Data Management, butare highly relevant to Data Management.Sessions will cover topics such as qualityaudits, partnering with other functions(Clinical, Stats) and technology.

Another new addition to the symposiumthis year is an organized social event atPhiladelphia’s Constitution Center. Weare excited about this opportunity tomingle and network in a historic settingand hope that all will attend!

Meeting Contact and Exhibit InformationMeeting attendees are welcome to visit the exhibits during the workshop and receptions.

The Drug Information Association (DIA) has been reviewed and approved as an Authorized Provider by theInternational Association for Continuing Education and Training (IACET), 1620 I Street, NW, Suite 615,Washington, DC 20006. The DIA has awarded up to 2 continuing education units (CEUs) to participants

who successfully complete this program and tutorials.

If you would like to receive a statement of credit, you must attend the program and return the credit request and evaluationforms to the DIA. Statements of credit will be issued within 30 days of receipt of these forms.

Disclosure Policy: It is Drug Information Association policy that all faculty participating in continuing education activitiesmust disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentationand (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Faculty disclosure will be included in thecourse materials.

Continuing Education Credit AllocationHalf-day Tutorials: .3 IACET CEUs

Conference: 1.4 IACET CEUs (CEUs will not be offered for the Keynote Address.)

Target Audience This program is designed for pro-fessionals who work in the areas of� Clinical data management� Clinical information technology� Medical coding� Systems validation� Biostatistics� Regulatory� Pharmacovigilance� Industry service providers� Statistical programming

For meeting information, contact Jessica Kusma,Program Manager at the DIA office in Horsham, PA

telephone +1-215-442-6182fax +1-215-442-6199email [email protected]

For exhibit information, contact Jeff Korn, ExhibitsAssociate at the DIA office in Horsham, PA

telephone +1-215-442-6184fax +1-215-442-6199email [email protected]

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Spec

ial

Even

ts

3

About Vicky KeithFor over 25 years, VickyKeith has led large corporations through the quagmire of complexorganizational changeand strategy implementa-tion. She has worked withsuch giants as IBM,General Electric andPepsiCo, with clinicalorganizations withinBoston Scientific, Bristol-

Myers Squibb, McKesson and Pfizer, with data managementorganizations like First Data Corporation and Transamerica,and with health related organizations like the World Bank,Management Sciences for Health and GE Medical Systems.Her unique perspective on change makes Vicky's messageentertaining, informative, and relevant to life in Clinical DataManagement.

SpecialOffer

KEYNOTEChange is Good: Understanding and Mastering Change

1 Date —1 Location — 2 Meetings!For the first time, DIA is offeringco-located meetings: 21st AnnualDIA Clinical Data ManagementSymposium and Exhibition andR&D Meets HIT: Using ElectronicHealth Records to StreamlineClinical Trial Operations: HealthcareIT Transforming DrugDevelopment.

Co-locating these two meetings willoffer enhanced benefits to all atten-dees, as registered attendees foreither meeting will have full accessto both meeting sessions. Also, withcombined breaks and receptions aswell as a shared exhibit hall the networking opportunities will beendless!

To view the agenda for this co-located meeting please visit www.diahome.org.

Networking ReceptionMonday, March 27, 2006

5:30-7:00 PM

Spend an Evening at the National ConstitutionCenter

Enter as a Visitor ... Leave as a CitizenThe National Constitution Center is located in the heart ofPhiladelphia’s historic area on Independence Mall. This museum

is the first in the world dedicated to honoring and explainingthe U.S. Constitution. The Constitution will be brought tolife through numerous interactive and unique exhibits.

Transportation will be provided to and from the PhiladelphiaMarriott Downtown for meeting attendees.

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

4

At A

Gla

nce

Conference at a Glance

Implementing CDISC—Postcards From the Jungle

Standards-based Clinical Safety DataReconciliation: Mapping E2B and SDTM

TRACK 1Form Follows Function or Function

Follows Form?Organizational Structures in Data

ManagementA Global Data Management Organization of a

European-based Pharma Company

TRACK 2Data Quality and Good Clinical Practices

Regulatory Considerations with Technology forAchieving Data Quality

Achieving Data Quality in Device Clinical Trials

Quality Audits and Impact on Query Resolution

TRACK 3

Data Mangement Procedure Review MedDRA Coding Strategy for a Multiyear

MegatrialEffective EDC Pilots for Effective EDC ProgramsUsing Data Status Metrics (and a good process)

to Manage a Trial

TRACK 1Managing Data Management

An Elephant in the Room and Perpetual Change by Design

Creating, Building, and Managing an EverChanging Global CDM Organization

Managing a Clinical Data ManagementDepartment in Times of Extraordinary Change

TRACK 2Data Management Technology

Technology in Clinical Trials: The Right Tools for the Job

Improving Workflow through Electronic CDM Technologies

Connecting the Dots: Integration andInteroperability of Clinical Systems

TRACK 3

A Town Hall on e-Source

Interactive panel discussion on e-Source with representateives from FDA, CDISC, Duke

University, EHR and EDC vendors and thePharma industry

TRACK 1Measuring Data Management—

Toward a Managed ProcessLooking Beyond the Numbers: The Effective Use

of Metrics in Managing Clinical Data

Management Metrics: Eliminate Risks, HaveControl, and Meet Regulatory Mandates

The Methodology of Process Metrics in Leading an Organization to Success

TRACK 2Partnering with Clinical

Mars and Venus Really DO Need to UnderstandEach Other

Practical Strategies for Bridging the Gap andCreating Clinical CDM Partnerships

eClinical: A Site Perspective

TRACK 3

11am - 12pm Plenary Session 3: Data Standards: Critical to the Critical Path Initiative at the FDA

12 - 1:30pm Luncheon in the Exhibit Hall

1:30 - 3pm Parallel Tracks

3 - 3:30pm Refreshment Break


Sunday, March 26, 20068 - 9am Tutorial Registration and Continental Breakfast

9am - 12:30pm Concurrent Tutorials 1 & 2#1 Clinical Statistics for Nonstatisticians#2 Managing Data Management: The Executive Challenge for Today’s Research

10am - 3pm Exhibitor Registration and Booth Set-up

1:30 - 5pm Concurrent Tutorials 3, 4 & 5#3 Managing Projects and Being Project Managed: How to Get Things Done in Data Management#4 Overview of the Pharmaceutical Industry#5 EMR 101

4 - 6pm Attendee and Speaker Registration/Exhibit Hall open

5 - 6pm Reception in the Exhibit Hall

Monday, March 27, 20067 - 8am Registration/Continental Breakfast in Exhibit Hall/Exhibit Hall Opens

8 - 9:30am Plenary Session 1: Welcome and Keynote Address

9:30 - 10am Refreshment Break

10 - 11am Plenary Session 2: Clinical Data Management is Going to Change Dramatically. Why, How andWhen, and What Should We do to Get Ready?

5:30 - 7pm Offsite Reception - National Constitution Center

Tuesday, March 28, 20067 - 8am Registration and Continental Breakfast

8 - 9:30am Parallel Tracks

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

5

At A

Gla

nce

9:30 - 10am Refreshment Break/Exhibit Hall opens at 9:30am



10 - 11:30am Plenary Session 4: Data Standards: Critical to Safety Data Analysis by FDA

11:30am Meeting Adjourned

Validation—Impact On CDMProfessionals

Illustration of Automated Testing for Use in EDC System Validation

Computer System Validation “Lessons Learned”

TRACK 1Innovative Methods For Training Data

Managers

Structure for Combining Training with Career Development

Out of the Classroom: Alternative Venues for Training

Training Data Managers to Keep Pace withEvolving Roles in the Changing Landscape of

Research & Development

TRACK 2Beyond Data Management

Teaming the Data Managers and Statistician:Planning and Teamwork Yields the Best Results

Web-based Audio Computer Assisted Interviewing

What you Need to Know About DataManagement in Phase IV and Post-Approval Trial

TRACK 3

EDC Screen Design: Vehicle for Success

“Clinical” UAT in EDC: Paying Attention to the Real User

Electronic Data Capture Design

TRACK 1Managing Change in the DM

Organization

The Evolution of the Data Manager Role

EDC-driven Functional Changes

Globalization of Clinical Data Management and its Impact

TRACK 2What You Could Learn from a CRO

A New Model for Optimizing Clinical DataManagement

Best Practices for Change Management in aGlobal Data Management Organization

Hiring a Consultant

TRACK 3

The Impact of Data Capture and Qualityon Coding

When Good Data Quality is Not Enough:How Fungus Can Become a Worm or Neoplasm

MedDRA Coding Conventions as a By-product of Data Conversions

TRACK 1Global Data Management

Managing an Offshore Biometrics Center

Offshore—Myths and Reality

The Journey to Global (not International) DataManagement

TRACK 2Data Management and Biostatiscal

Organization for Effective Implementationof Adaptive Clinical Designs

Electronic Data Capture

Process Improvement Initiative: Query Analysisand Breakdown on EDC Trials

Improving Decision Making in DataManagement through Visualization of EDC Data

Using EDC in a New Paradigm to Save ProjectTime and Costs

TRACK 3

TRACK 3MedDRA Training Strategies

MedDRA Training and Monitors and Investigator Sites

Training Strategies to Improve Data Quality and Optimize Coding with MedDRA

MedDRA Training

TRACK 1More Managing Data Management

The 3 Managements: Projects, Data, and Clinical Data – Making It Work for the

CDM Professional

Building Effective Cooperation Between the CDM and CRA in the EDC Environment

Creating a Seamless Interdisciplinary Team

TRACK 2

11:30am - 1:30pm Luncheon in Exhibit Hall


3 - 3:30pm Refreshment Break in the Exhibit Hall/Exhibit Hall closes


Wednesday, March 29, 20067 - 8am Registration and Continental Breakfast


CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Exhi

bit

Hal

l

6

Exhibit Hall Floor Plan

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Exhi

bit

Hal

l

7

Exhibitor Information

Exhibitors (as of February 1, 2006)

AAIPharma

ACS Clinical

Applied Clinical Trials Magazine

Averion Inc.

ClinForce, Inc.

ClinPhone Inc.

ClinPro Inc.

CRF Inc.

DataLabs, Inc.

DATATRAK International

DSG (Document Solutions Group)

eResearchTechnology, Inc.

Ferraris Respiratory

i3 Statprobe

ICON Clinical Research

Image Solutions, Inc.

Imperial Graphics, Inc.

INC Research

Integrated Clinical Systems Inc.

Interactive Clinical Technologies (ICTI)

Invivodata, Inc.

Kforce Clinical Research Staffing

MedFocus, Inc

META Solutions, Inc.

Northrop Grumman

Octagon Research Solutions

Omnicomm Systems Inc.

Open Text Corporation

Oracle Corporation

Paragon Biomedical, Inc.

Pendulum

PharmaNet

PharmaSoft

Phase Forward

Placemart Personnel Service

PPD, Inc.

Provisio

Quintiles

RPS, Inc.

Strata

The Uppsala Monitoring Centre

Ventiv Clinical Solutions

VIASYS Healthcare

Exhibit Hall HoursSunday, March 26 4 - 6pmThere will be an opening reception in the exhibit hall from 5 - 6pm.

Monday, March 27 7am - 5pm

Tuesday, March 28 9:30am - 3:30pm

Don’t miss this opportunity to exhibit in the 7,200 square foot Exhibit Hall!

For more information, contact:Jeff Korn, Exhibits Associate telephone +1-215-442-6184 email [email protected]

Sunday, March 26, 10am - 3pm – Exhibitor Registration and Booth Set-up

Sunday, March 26, 2006 (Tutorials Only)

8 - 9am Tutorial Registration and Continental Breakfast

9 - 12:00pm Concurrent Tutorials 1 & 2

#1 Clinical Statistics for Non-Statisticians(.3 IACET CEUs)

Corina Sirbu, PhD

Kay M. Larholt, ScDBoston Scientific Corp.

OverviewThis tutorial will concentrate on the philosophy and under-standing of the basic statistical principles required in conduct-

ing clinical research investigations. It will provide a short reviewof the terminology and the methods employed to ensure thatclinical trials are designed and analyzed appropriately.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:

� Discuss the importance of statistics in clinical trials and basicprinciples of medical statistics

(continued on page 8)

1 - 4pm Concurrent Tutorials 3, 4 & 5

#2 Managing Data Management: The ExecutiveChallenge for Today’s Research(.3 IACET CEUs)Ronald S. Waife, MPHPresident, Waife & Associates, Inc.Joseph S. AndersonPrincipal Associate, Waife & Associates, Inc.

OverviewClinical Data Management is undergoing more change in this decade than in the last two decades combined. This placesconsiderably more strain on the skills of executives responsiblefor this function. This Tutorial is a mini-MBA for leaders ofdata management, covering the myriad of issues facing them.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:

� Organize and govern tomorrow’s biometrics organization

� Understand the implications of data transparency and the

necessity of interaction and involvement with drug safetyand postmarketing functions

� Understand the pressures facing clinical operations manage-ment, and how data management must support and derivesupport from them

� Discuss the bombardment of new technologies and how tomanage a technology strategy, interactions with vendors, theprocess changes required, competing interests, and limitedbudgets

� Maintain an iterative process change environment withoutsuccumbing to change fatigue

� Manage your personnel in the meantime – maintainingmotivation while pushing for new skills

� Identify if you are ready for leadership

Target AudienceThis tutorial is designed for Executive management of datamanagement, biometrics, clinical IT or clinical operations.

#3 Managing Projects and Being Project Managed:How to Get Things Done in Data Management(.3 IACET CEUs)

Kristin M. Neff, MSClinical Program Manager, Boston Scientific Corp.Denise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

OverviewAs a data manager moves up the career ladder, they move fromthe task-oriented work of a junior player, to being “project-man-aged”as part of a working team, and then to managing their ownspecial projects. In this tutorial, we will examine the skills andbehaviors expected of someone who is part of a team being led bya project manager. Then we will discuss the roles and responsibili-ties of a project manager, both within the project team and withinthe organization. Finally, we will explore the traditional projectmanagement skills – planning, tracking, reporting, and process

improvement – that data managers can develop and use whenmanaging their own initiatives. Participants will practice their project management skills in a project-planning exercise that focuses on negotiation and adjustment.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Identify the skills and behaviors expected of a data manager

who is part of a team led by a project manager� List the roles and responsibilities of a project manager� Draft a focused, yet thorough, project plan including objec-

tives, tasks, schedule, resources, risk management measures,and contingencies

Target AudienceThis tutorial is designed for data managers, database managers,line managers, data management project managers, anyone interested in learning the basic skills required of a project manager.

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Tuto

rial

s

8

12 - 1pm Luncheon Break (Attendees are responsible for obtaining lunch)

10am - 3pm Exhibitor Registration and Set-up

� Describe the statistical principles in the design of clinical trials

� List different elements involved in sample size calculations,significance testing and interpretation of the results of statistical analyses

Target AudienceThis tutorial is designed for individuals within the pharmaceu-

tical and biotech industries including data managers, medicalinvestigators, basic and clinical research scientists, clinicalresearch associates, those involved in regulatory affairs, statistical programmers. The tutorial is oriented toward professionals having no formal training or qualifications inmedical statistics, but need a basic understanding as part oftheir role.

Sunday, March 26, 2006 (Tutorials Only — Tutorial #1 continued)

(continued)

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

#4 Overview of the Pharmaceutical Industry(.3 IACET CEUs)Kim Slocum, FHIMSSDirector, Strategic Planning and Business Development,AstraZeneca

George D’Addamio, FHIMSSPresident, PharmConsult, Inc.

OverviewThis introduction to the pharmaceutical industry will providestakeholders in healthcare information technology with aninside view of how pharmaceutical decision-makers are meetingthe challenges of drug development, clinical trials and productmarketing – and how they expect to benefit from the use ofhealthcare data. Attendees will gain valuable insights into theprocesses used to select and work with vendors, performancebenchmarks, and how to avoid pitfalls. Kim Slocum will offerinteresting perspectives as to how the industry functions at amacro level, how the drug discovery, development, submission

and commercialization process operates – as well as the chal-lenges that we collectively face. He will be accompanied bymembers of the Drug Information Association who can alsoaddress these issues.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Discuss the pharmaceutical industry’s key expectations of

healthcare data to speed drug development processes� Explain the need to move from traditional approaches to this

new data-driven model� Describe the “ins and outs” of working with pharmaceutical

decision makers

Target AudienceThis tutorial is designed for individuals in the area of healthcareinformation technology.

Tuto

rial

s

9

4 - 6pm Attendee and Speaker Registration

10 - 3pm Exhibitor Registration

4 - 6pm Exhibit Hall open

5 - 6pm Reception in the Exhibit Hall

#5 EMR 101(.3 IACET CEUs)

Randy Thomas, FHIMSSFellow, IBM Center for Healthcare Management BusinessConsulting Services

OverviewPharmaceutical industry stakeholders will learn from healthcareinformation technology (HIT) professionals about initiatives fordeveloping and implementing electronic medical records/elec-tronic healthcare records.

Participants will hear some of the challenges and successes in themarketplace, including HIPAA requirements as well as the per-spectives of physicians/hospitals, government, the private sectorand patients. This session will also include a “hands-on”demonstration of populating the EHR as well as factors thatimpact implementation or interoperability. The breadth and

scope of EHR data will be examined giving attendees the opportunity to explore the use of this information in drugdevelopment.

Learning ObjectivesAt the conclusion of this tutorial, participants should be able to:� Discuss the challenges and opportunities for healthcare data

collection � Describe the potential for leveraging EHR data in drug

development� Identify how to access data and work with vendors

Target AudienceThis tutorial is designed for individuals in the pharmaceuticalindustry.

1 - 4pm Concurrent Tutorials 3, 4 & 5 (continued)

8 - 9:30am Plenary Session 1

9:30 - 10am Refreshment Break/Exhibit Hall opens

10 - 11am Plenary Session 2

12 - 1:30pm Luncheon/Exhibit Hall opens

Change is Good: Understanding and MasteringChangeIt is difficult to get things done while everythingaround you is rapidly changing. Once you under-stand the dynamics, you can actually have fun withchange and make it work for you.

Clinical Data Management is Going to ChangeDramatically. Why, How and When, and What Should WeDo to Get Ready?Session ChairJonathan LangePartner, Accenture

Pharmaceutical companies are aggressively outsourcing and off-shoring, new non-traditional players are emerging, and the elec-tronic medical record is getting ready to take hold.

These changes all paint a picture of a dramatic shift in ClinicalData Management. What are these changes, how will theyimpact you, and what can you do to get ready?

11 - 12pm Plenary Session 3

Data Standards: Crictical to The Cricital Path Initiative atthe FDASession ChairsB. Sue Bell, PhDSenior Statistical Reviewer, Division of Biometrics III, CDER,FDA

Kim W. Nitahara, MBA, MITCEO, META Solutions, Inc.

The Agency is actively collaborating with Industry, vendors, andhealth research organizations to make the vision of clinical trialdata standards a reality. The Clinical Research InformationExchange (CRIX) represents one view of the future. CRIX is acollaborative effort lead by the National Cancer Institute inagreement with the FDA to build a shared, standards-based

collaborative research infrastructure. CRIX includes a globalinvestigator registry (Firebird/SAFE), a standards-based reposito-ry for structured clinical data (Janus), and infrastructure for elec-tronic submissions (eCTD). Meanwhile, the Agency is preparingfor this next generation by continuously improving its ability toaccept electronic submissions. This is an opportunity to learn thelatest on how the Agency is moving forward.

CRIX: Toward a Shared Clinical InfrastructureBrenda R. Duggan, RN, BSNProgram Manager, Clinical Informatics, Center for Bioinformatics,NCI, National Institutes of Health

FDA Data Standards Initiatives: An UpdateStephen E. Wilson, DrPH, Capt. USPHSDirector (Acting), Office of Business Process Support, CDER, FDA

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Sche

dule

10

Monday, March 27, 2006

7 - 8am Registration and Continental Breakfast

8:15 - 9:30amKeynote AddressVicky KeithMaster of Change

8:00 - 8:15amWelcome and Opening RemarksKristin M. Neff, MSClinical Program ManagerBoston Scientific Corp.

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

3 - 3:30pm Refreshment Break

1:30 - 3pm TRACK 3

1:30 - 3pm TRACK 2

Data Quality and Good Clinical PracticesSession ChairMichael R. Hamrell, PhDMORIAH Consultants

This session will provide several perspectives on the role of GCPand audit in clinical compliance and assuring data quality. Theadvantage for companies lies in not only how fast clinical datacan be collected, but also on the quality of the data and the valuethe data provides to the company. To assure quality data, clinicalcompliance and oversight must be an integral part of the CDMprocess. In addition, there are new and different challenges pre-sented when data collection involves an electronic-based process.This session will examine the process of getting to a clean data-base with the implementation of quality checkpoints and subject-based data locking. In this regard, the quality of the submission ispivotal, and thus the clinical section and data management issuesare an important aspect of product development.

Regulatory Considerations with Technology for AchievingData QualityMichael R. Hamrell, PhDMORIAH Consultants

Achieving Data Quality in Device Clinical TrialsKaren FrankoManager, Clinical QA, Boston Scientific Corp.

Quality Audits and Impact on Query ResolutionReza Rostami, MBAManager, Clinical Data Management, Duke Clinical ResearchInstitute

Form Follows Function or Function Follows Form?Organizational Structures in Data ManagementSession ChairDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

In this session, three speakers will present their organizationalcharts and talk about how their organizational structureimpacts workflow, governance, budgeting, purchasing deci-sions, and relationships with other departments.

A Global Data Management Organization of a European-based Pharma CompanyJohann Pröve, PhDVice President Data Acquisition and Management, Bayer VitalGmbH

Presentation Title to be determinedRob GoodwinExecutive Director, Global Clinical Data Services, WorldwideDevelopment, Pfizer

Para

llel T

rack

s

11

1:30 - 3pm TRACK 1

Implementing CDISC—Postcards From the JungleSession ChairChris A. LeGrand, MSPresident, Constella Group, Inc.

Standardizing around CDISC is elegant and simple in concept,and holds the promise to be one of the key catalysts towardsreengineering of the clinical research process. Yet, attempts atpractical implementation of CDISC have been difficult andresource intensive. This session provides some encouraging casestudies of success stories “from the CDISC jungle” and lessonslearned for future implementations of various components ofCDISC.

Standards-based Clinical Safety Data Reconciliation:Mapping E2B and SDTMRobbert P. Van ManenWorldwide Technical Director, Lincoln Technologies

Brenda R. Duggan, RN, BSNProgram Manager, Clinical Informatics Center for Bioinformatics,NCI, National Institutes of Health

Parallel Tracks

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Para

llel T

rack

s

12

5:30 - 7pm Off-site Reception: National Constitution Center

3:30 - 5pm TRACK 3

3:30 - 5pm TRACK 2

Data Management Technology Session ChairJohann Pröve, PhDVice President Data Acquisition and Management, Bayer VitalGmbH, Germany

The session on Data Management Technology will highlight thetechnological opportunities available for data management, suchas the integration of different systems used in data managementand the processes requiring a change after new technologieshave been implemented.

Technology in Clinical Trials: The Right Tools for the Job Fritz HaasVice President Information Technology, ICTI

Improving Workflow through Electronic CDMTechnologiesTony VaranoPresident/CEO, DSG Inc.

Connecting the Dots: Integration and Interoperability ofClinical SystemsMarie MacDonaldDirector, Strategic Product Development, ClinPhone Inc.

Managing Data ManagementSession ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp.

Managing Data Management organizations can be challenging,particularly in our ever-changing environments. There arechanges in organizations, changes in resourcing and changes inthe scope of the work that needs to get done. In this session,leaders for Data Management organizations will present theirstrategies for effective management amidst their complex andever-changing environments.

An Elephant in the Room and Perpetual Change by DesignStacy SurenskyDirector of Clinical Data Management, Vertex PharmaceuticalsIncorporated

Creating, Building, and Managing an Ever ChangingGlobal CDM OrganizationCathie MuzaDirector of Data Management, Boston Scientific Corp.

Managing a Clinical Data Management Department inTimes of Extraordinary ChangeDeborah LucasManager of Clinical Data Management, Biogen IdecCarol McKennaSenior Manager of Clinical Data Management, Biogen Idec

Parallel Tracks, continued

3:30 - 5pm TRACK 1

Data Mangement Procedure ReviewSession ChairColleen M. Cox, CCDMManager, Data Management, PROMETRIKA

The three abstracts will present experiences of how the ongoingreview and updating of data management procedures can benefitthe project/submission, the department and the company. Thesession includes a review of MedDRA coding over the course ofa multi-year trial, the effective use of EDC pilots and using met-rics and procedures to manage a large scale trial.

MedDRA Coding Strategy for a Multiyear MegatrialRenee Cacchillo, RACClinical Data Management Associate, Data Management, EliLilly and Company

Effective EDC Pilots for Effective EDC ProgramsDavid FishbachConsulting Manager, Phase Forward

Using Data Status Metrics (and a good process) to Managea TrialJohn SnappManager, Technical Resources, Duke Clinical Research Institute

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Para

llel T

rack

s

13

Tuesday, March 28, 2006 Parallel Tracks7 - 8am Registration and Continental Breakfast

8 - 9:30am TRACK 3

Partnering with ClinicalSession ChairRonald S. Waife, MPHPresident, Waife & Associates, Inc.

This session explores the changing ways that CDM and ClinicalOperations are working together, including organizationalchanges that put them in the same department; exchange ofsome responsibilities between groups; and strategies for moreeffective communication and streamlined workflow.

Mars and Venus Really DO Need to Understand Each OtherRonald S. Waife, MPHPresident, Waife & Associates, Inc.

Practical Strategies for Bridging the Gap and CreatingClinical-CDM PartnershipsRamzi NajmDirector R&D Systems and Information Services, Allergan

eClinical: A Site PerspectiveNate BlevinsIS Business Partner, AstraZeneca

8 - 9:30am TRACK 1

A Town Hall On e-SourceSession ChairCatherine CelingantDirector, Clinical Data Management, MillenniumPharmaceuticals, Inc.

With the increasing use of electronic data capture (EDC) andelectronic patient reported outcomes (ePRO), along with afuture vision of merging data from electronic medical records(EMR) into clinical trial databases, the topic of electronic source(eSource) has never been more key or relevant to the success ofour business as it is today. Industry and regulatory perspectiveson eSource will be shared in a town hall format.

PanelistsHugh DonovanGeneral Manager Clinical Trial Business, Siemens MedicalSolutions Health Services Corp.

8 - 9:30am TRACK 2

Measuring Data Management—Toward A ManagedProcessSession ChairChris A. LeGrand, MSPresident, Constella Group, Inc.

Data management, can be, should be, an engineered workprocess. Mature management principles call for building inmeasurement of elements of any process to create a “managedprocess” that is continuously improving, reducing risk, increasingquality and efficiency. The speakers in this session will explorevarious aspects of implementing metrics within data manage-ment to create a managed data management process, includinghow to implement metrics transparently, examples of best prac-tice metrics, and the underlying requirements for collection andanalysis of metrics.

Looking Beyond the Numbers: The Effective Use ofMetrics in Managing Clinical DataCorey DunhamManager, Clinical Data Management, Averion Inc.

Management Metrics: Eliminate Risks, Have Control, andMeet Regulatory MandatesReza Rostami, MBAManager, Clinical Data Management, Duke Clinical ResearchInstitute

The Methodology of Process Metrics in Leading anOrganization to SuccessDavid EvansChief Information Officer, Octagon Research Solutions, Inc.

Charles N. Mead, MD, MSSenior Director, Healthcare and Life Sciences Strategy, OracleRob Goodwin, MS, MBAExecutive Director, Global Clinical Data Services, PfizerSuzanne Markel-Fox, PhDDirector, Strategy and Process Excellence, GlaxoSmithKlinePaul Bleicher, MD, PhDChairman and Founder, Phase ForwardMark Dente, MDDirector, Healthcare Solutions, GE HealthcareLanden BainHealthcare Liaison, CDISCKen Gersing, MDDirector of Clinical Information Services, Dept. of Psychiatry,Duke University Medical CenterFDA Representative invited

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Para

llel T

rack

s

14


11:30am - 1:30pm Luncheon in Exhibit Hall

10 - 11:30am TRACK 3

Beyond Data ManagementSession ChairJohann Pröve, PhDVice President Data Acquisition and Management, Bayer VitalGmbH, GermanyThe session on Beyond Data Management is going to touchthree different areas that are linked to Data Management activi-ties, however, may not always be in focus. Close cooperationwith statisticians for a successful study completion, the use ofother technology than EDC, and aspects for the handling ofphase IV trials will be presented in this session.

Teaming the Data Managers and Statistician: Planning and Teamwork Yields the Best ResultsEva MillerAssociate Director Biostatistics, ICTI

Web-based Audio Computer Assisted InterviewingConstance Klein, MBASenior Project Manager, Data Management, Nathan Kline Institute

What you Need to Know About Data Management in Phase IV and Post-Approval TrialRichard Glocklich

10 - 11:30am TRACK 2

Innovative Methods for Training Data ManagersSession ChairDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

This session explores innovative ways to integrate training intoclinical data management, to ensure that training is relevant,timely, and effective, with measurable results. Speakers will present case histories of training efforts, with a focus on the“professionalization” of data management.

Structure for Combining Training with CareerDevelopmentRita Nespeca, MSCManager, Data Management, AAI Pharma, Inc.

Out of the Classroom: Alternative Venues for TrainingDenise DeRenzo Lacey, MA, MSAssociate, Waife & Associates, Inc.

Training Data Managers to Keep Pace with Evolving Rolesin the Changing Landscape of Research & DevelopmentAngelo T. Scarsella, MASenior Data Analyst, Takeda Pharmaceuticals North America

10 - 11:30am TRACK 1

Validation—Impact on CDM ProfessionalsSession ChairChris A. LeGrand, MSPresident, Constella Group, Inc.The basic concepts of system and study-level validation havebeen discussed and examined for several years at various industryconferences and symposia. This session, however, explores practi-cal lessons learned and case studies of validation of clinical datacollection and management systems, with specific emphasis onthe impacts on CDM professionals, including their role andresponsibilities and the decisions they have to make.

Illustration of Automated Testing for Use in EDC SystemValidationKaren SteenhoudtConsultant, Validation

Computer System Validation “Lessons Learned”Ken O’BrienDirector, Process Quality Management, Perceptive Informatics

Validation of Newly Adopted Enterprise TechnologiesThurman HamletDuke Clinical Research Institute

9:30 - 10am Refreshment Break/Exhibit Hall opens at 9:30am

3 - 3:30pm Refreshment Break/Exhibit Hall closes at 3:30pm

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Para

llel T

rack

s

15


1:30 - 3pm TRACK 3

What You Could Learn from a CROSession ChairColleen M. Cox, CCDMManager, Data Management, PROMETRIKA

This session will focus on the unique perspective that a CROcan provide. The abstracts include a discussion of the develop-ment of a dedicated team to address sponsor needs, managingchange and expectations in a CRO environment and theadvantage of hiring a consultant to assist with the growth andsupport of a DM department.

A New Model for Optimizing Clinical Data ManagementN. Susan SlagleSenior Director, Clinical Project Management, Ventiv ClinicalSolutions

Best Practices for Change Management in a Global DataManagement OrganizationJeanne AshtonExecutive Director, Data Management, PharmaNet

Hiring a ConsultantPati StonePrincipal Consultant, Helios Consulting Services, LLC

1:30 - 3pm TRACK 2

Managing Change in the Data Management OrganizationSession ChairJonathan Haddad, MT (ASCP), MPHDirector, Biometrics, Synta Pharmaceuticals Corp.

Presentations will address various aspects of change occurring inClinical Data Management today with particular emphasis onhow these changes affect staff as well as strategies for managingthrough these dynamic times. Case studies will be discussed.

The Evolution of the Data Manager RoleKimberly Tiefenbach, BA, MEDDirector, Clinical Services and Support, OmniComm Systems

EDC-driven Functional ChangesMichael WrightSenior Director of Biometrics, Research Pharmaceutical Service

Globalization of Clinical Data Management and its ImpactRalph HarkinsVice President of Biometrics, Otsuka Maryland Research Institute

1:30 - 3pm TRACK 1

EDC Screen Design: Vehicle for SuccessSession ChairHeather WolffAssociate Director, CDM, Oncology, Millennium Pharmaceuticals,Inc.

Everyone wants to have a successful outcome in terms of datacollection compliance and quality in their EDC screens. Whathas worked for others to achieve this goal? A range of sugges-tions and ideas will be discussed in this session, including screencompilation and multi-type data collection approaches and per-forming UAT from a site perspective.

“Clinical” UAT in EDC: Paying Attention to the Real UserEve-Marie Whitsun-JonesAssociate, Waife & Associates, Inc.

Electronic Data Capture DesignValerie WilliamsManager, Advance Technology Setup, PharmaNet, Inc.

Efficiency Approaches to Multiple Electronic Data CaptureTrialsPatrick J. BurnsPrincipal Priject Manager, Phase Forward, Inc.

End of Day 2

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Para

llel T

rack

s

16

3:30 - 5pm TRACK 3

Data Management and Biostatistical Organization forEffective Implementation of Adaptive Clinical DesignsSession ChairBarry A. Turnbull, PhDVice President, Biometrics, BattelleCRO

This session will present an overview of the interactions and newworkflows needed to effectively implement the data-driven interimdecision making required in adaptive clinical trials. Attendees willbe made aware of the basic principles of adaptive designs but, moreimportantly, they will learn the types of changes in traditionalClinical Data Management (CDM) processes required in order to take full advantage of benefits of these types of trial designs.

The importance of CDM’s participation and interaction withBiostatistics on accelerated data capture, cleaning and codingwithout sacrifice of CDM best practices or overall data qualitywill be covered via a company’s specific experiences.

Jerald S. Schindler, DrPH, PharmDPresident, Cytel Pharmaceutical Research

Katherine CoxClinical Data Manager, Genzyme

Barry Turnbull, PhDVice President, Biometrics, BattelleCRO

3:30 - 5pm TRACK 2

Global Data ManagementSession ChairJohann Pröve, PhDVice President Data Acquisition and Management, Bayer VitalGmbH, Germany

The session on Global Data Management will address the hottopic of off-shoring data management and the aspects to takeinto account when going that route. The second part will sharethe experience made when changing a data management organi-zation from a regional / international organization into a globaldata management operation.

Managing an Offshore Biometrics CenterMunish MehraSenior Vice President Clinical Research, Medifacts

Offshore—Myths and RealitiesManjappa Belur ChittaranjanVice President, IDS America Inc.

The Journey to Global (not International) DataManagementPaula Brown StaffordExecutive Vice President, Quintiles


3:30 - 5pm TRACK 1

The Impact of Data Capture and Quality on CodingSession ChairPatricia Mozzicato, MDMedical Officer USA, Northrop Grumman Corporation

Medical data and drug name encoding are critical functionswithin the clinical trial and post-marketing safety data manage-ment processes, but coding alone cannot guarantee quality out-put for analysis. Regardless of whether a company encodesrecords manually or via an autoencoder with downstream med-ical review, the approach to improving data quality and capturewill determine the efficiency of the coding process, given thatqueries and data clarification requests are directly impacted.

As companies have implemented newer terminologies, they alsofaced the dilemma of coding guidelines and how to adapt fordatabase conversion. In this session, we will focus on the impor-tance of data collection instruments and coding conventions,

and how they both require re-engineering to accommodate glob-al terminology standards.

When Good Data Quality is Not Enough: How Fungus CanBecome a Worm or NeoplasmMarie Lou Gacusan-Munson, MDManager, Medical Coding, Gilead Sciences, Inc.

MedDRA Coding Conventions as a By-product of DataConversionsPatricia Mozzicato, MDMedical Officer USA, Northrop Grumman Corporation

Accurate and Consistent Data Coding Can Be Accomplishedwith Quality Data CaptureEric Tate, BSNClinical Coding Specialist, MedImmune, Inc.

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Wednesday, March 29, 2006 Parallel Tracks


Para

llel T

rack

s

17

8 - 9:30am TRACK 3

Electronic Data CaptureSession ChairJohann Pröve, PhDVice President Data Acquisition and Management, Bayer VitalGmbH, Germany

The session on Electronic Data Capture will look into variousaspects of a successful implementation of EDC and how EDCimplementation can be managed, which processes must bechanged and how the true costs can be identified.

Process Improvement Initiative: Query Analysis andBreakdown on EDC TrialsAnthony GoncalvesManager, Data Management, Serono Inc.

Improving Decision Making in Data Managementthrough Visualization of EDC DataSam HumeVice President, Technical Operations, Phoenix Data Systems, Inc.

Using EDC in a New Paradigm to Save Project Time andCostsLorraine D. Ellis, MS, MBAPresident/CEO, Research Dynamics Consulting Group, Ltd.

8 - 9:30am TRACK 1

MedDRA Training StrategiesSession ChairJudy HarrisonClinical Research Consultant, Harrison Clinical Consulting, Inc.

Training in MedDRA is often underestimated in scope of deliv-ery and importance. More often than not, the coders are theonly function targeted for in-depth training on MedDRA and oncompany-developed coding guidelines.

In fact, those who perform analysis and medical review shouldreceive these trainings in addition to training focused onMedDRA-encoded data analysis and interpretation. In order tounderstand data in any form of output, one must fully compre-hend everything that occurs at the time of input. In this session,we shall discuss proven training strategies involving all functions

from the site monitors collecting data to the physicians reviewingit, and every role in between.

MedDRA Training and Monitors and Investigator SitesSandra NolotSenior Coding Associate, Eli Lilly and Company

Training Strategies to Improve Data Quality and OptimizeCoding with MedDRAJudy Harrison, MDClinical Research Consultant, Judy Harrison Clinical ConsultingLLC

MedDRA TrainingSonja Brajovic, MDMedical Coding Manager, PSI International

7 - 8am Registration and Continental Breakfast

8 - 9:30am TRACK 2

More Managing Data ManagementSession ChairKristin M. Neff, MSClinical Program Manager, Boston Scientific Corp.

Management is a complex activity and requires broad skills to be successful in today’s environment. This session will explore several aspects of management including the many ways that“management” is a critical element of Data Management, newapproaches to building effective teams, and changes in roles andresponsibilities due to EDC. Managers and non-managers welcome!

The 3 Managements: Project, Data, and Clinical Data—Making it Work for the CDM Professional Harry J. FisherPresident, PQ Consulting LLC

Building Effective Cooperation Between the CDM andCRA in the EDC EnvironmentTeresa AncukiewiczManager of Data Management, Boston Scientific Corp.

Creating a Seamless Interdisciplinary TeamLisa AnsaldoDirector of Data Management, PharmaNet

11:30am Meeting Adjourned

10 - 11:30am Plenary Session 4

Data Standards: Critical To Safety Data Analysis By FDASession ChairStephen E. Wilson, DrPH, Capt. USPHSDirector (Acting), Office of Business Process Support, CDER, FDA

The Agency is challenged to make science-based decisions aboutwhether a product’s benefits to users will outweigh its risks.Initial decisions are based on safety data collected during devel-opment including adverse event reports and laboratory data. If a safety signal arises post approval, the Agency revisits its prioranalyses. The Agency is concerned that a false positive safety signal could result in a potentially beneficial product not beingused while a missed safety issue could result in undue risk tousers. Standard data structures (e.g., Study Data TabulationModel) and standard terminologies (e.g., MedDRA) are vital toimproving the quality and the efficiency of conducting a clinicalsafety review of a product or a class of products.

In this session, the Agency will provide an overview of the latestguidances relevant to the collection and reporting of safety data.Second, a clinical reviewer will discuss the real world challengesfaced during a clinical safety review and will demonstrate thepotential for the latest generation of tools to facilitate the review.In conclusion, a statistical reviewer will show how a safety reviewcan go beyond tables of counts and percents to include powerfulgraphical and statistical summaries.

Critical Path to Improved Safety DecisionsArmando Oliva, MDAssociate Director for Policy, Office of New Drugs, CDER, FDA

A Clinical Reviewer’s Experience with Standards-based Dataand Tools for NDA Safety ReviewsCharles Cooper, MDClinical Reviewer, Division of Anti-Infective and OphthalmolgicProducts, CDER, FDA

Statistical Safety Reviews: Visions of What Can BeB. Sue Bell, PhDStatistical Reviewer, Division of Biometrics III, CDER, FDA

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.

Audio/Visual taping of any DIA Workshop is prohibited without prior written consent from DIA.

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

18

CDM

• M

arc

h 2

6-2

9,

20

06

• Philadelp

hia

Marr

iott

Dow

nto

wn

• Philadelp

hia

,PA

,U

SA

Addi

tion

al I

nfo

19

Clinical Data Management SIAC

Chris A. LeGrand, North American Chairperson

Johann Pröve, European Chairperson

DIA Contact: [email protected]

The mission of the SIAC is to:

• Establish a global forum to share, evaluate and dissemi-nate information on the processes, standards andtechnologies for the management of clinical data;

• Encourage participation by professionals who are in the biopharmaceutical and healthcare industries;

• Promote education, training and career development ofClinical Data Management professionals;

• Promote multi-disciplinary collaboration and under-standing;

• Increase the visibility and recognition of Clinical DataManagement as a professional discipline.

Special Interest Area Communities (SIACs)Providing members with opportunities for networkingand leadership is an important objective of DIA. Beingable to share common experiences with professionalcolleagues is one of the main reasons members join DIA.DIA Special Interest Area Communities create a networkof member subgroups who share the same professionalresponsibilities, disciplines, or interests. SIAC input helps DIA ensure that workshops, conferences, trainingcourses, publications, and other offerings meet the realneeds, goals, and concerns of that specific professionalcommunity.

SIAC ParticipationSIAC participation is open to all current DIA members.SIACs are multidisciplinary and strive for balanced rep-resentation from professionals in industry, academia,contract support organizations and government.

How Can I Become a SIAC Member?If you are interested in joining the Clinical DataManagement SIAC, please email:[email protected] or go to DIA’s website www.diahome.org

TRAVEL AND HOTEL We advise you to make your airline reserva-tions as early as possible to ensure availability. The nearest airport isPhiladelphia International Airport. The Marriott PhiladelphiaDowntown is holding a block of rooms at the reduced rate below untilMarch 3, 2006, for the DIA Meeting attendees, or until the block isfilled.

Single $182 Double $202To reserve your room, please contact the Marriott PhiladelphiaDowntown by telephone at +1-800-228-9290 or +1-215-625-2900, andmention the DIA Workshop. The Marriott Philadelphia Downtown islocated at 1201 Market Street, Philadelphia, PA 19107, USA.

United Airlines To obtain schedule information andthe best fares, call United Airlines’s Specialized MeetingReservations Center at 1-800-521-4041. Make sureyou refer to Meeting ID Number 571AK. Dedicatedreservationists are on duty 7 days a week from 8:00 AMto 10:00 PM EST.

This special offer applies to travel on domestic segmentsof all United Airlines, United Express, PED, and Unitedcode share flights (UA*, operated by US Airways, USAirways Express and Air Canada).

UNITED AIRLINES & US AIRWAYS

Save through Area Pricing and Discount Fees

Participants with Disabilities

DIA meeting facilities and overnight accommodations are accessible to persons with disabil-ities. Services will be made available to sensory-impaired persons attending the meeting ifrequested at least 15 days prior to meeting. Contact the DIA office to indicate your needs.

Special Interest Area Communities

DRUG INFORMATION ASSOCIATION800 Enterprise Road, Suite 200Horsham, PA 19044-3595 USA

Last Name Check if part of group registration � First Name M.I.

Degrees � Dr. � Mr. � Ms.

Job Title

Company

Address As required for postal delivery to your location Mail Stop

City State Zip/Postal Country

email Required for confirmation

Phone Number Fax Number Required for confirmation

Group Registrant #2 Last Name First Name Completed form required for each group registrant



REGISTRATION FORM Do not remove mailing label. Please return this entire page. 06004PLEASE CONSIDER THIS FORM AN INVOICE

Please check the applicable category: � Academia � Government � Industry � CSO � Student (Call for registration information)

21st Annual DIACLINICAL DATA MANAGEMENTSymposium and Exhibition

Delivering Quality Data EffectivelyIn a Changing Environment!Meeting ID #06004Marriott Philadelphia Downtown,Philadelphia, PA, USAMARCH 26-29, 2006

• 5 exciting tutorials being offered Sunday, March 26th

• 3 parallel tracks: Data ManagementFundamentals, Managing Data Management,Data Management – Other Perspectives

• Offsite reception will be held at the NationalConstitution Center

M E M B E R E A R L Y B I R D Register by MARCH 3, 2006 S A V E $ 1 8 0

Register online or fax this page to +1-215-442-6199

PAYMENT OPTIONS Register online at www.diahome.org or check payment method

� CREDIT CARD number may be faxed to: +1-215-442-6199. You may prefer to pay by check or bank transfer sincenon-U.S. credit card payment will be subject to the currency conversion rate at the time of the charge.

�� Visa �� MC �� AMEX Exp Date _______________________________________

Card # _______________________________________________________________________________

Name (printed) _________________________________________________________________________

Signature ____________________________________________________________________________� CHECK drawn on a US bank payable to and mailed along with this form to: Drug Information Association Inc, P.O. Box

95000-1240, Philadelphia, PA 19195-1240, USA. Please include a copy of this registration form to facilitate identificationof attendee.

� BANK TRANSFER When DIA completes your registration, an email will be sent to the address on the registration formwith instructions on how to complete the Bank Transfer. You may pay in the currency of your choice. Your name and com-pany, as well as the Meeting I.D. # must be included on the transfer document to ensure payment to your account.

CONTACT & EXHIBIT INFORMATIONAttendees may visit the exhibits during the meeting and during receptions (if applicable).

Meeting information: Contact Jessica Kusma at the DIA office by telephone +1-215-442-6182, fax +1-215-442-6199 or email [email protected].

Exhibit information: Contact Jeff Korn Exhibits Associate, at the DIA office by tele-phone +1-215-442-6184, fax +1-215-442-6199 or email [email protected]. Forexhibit space, please check the box below.

� To receive an exhibit application, please check.

GROUP DISCOUNTS (not available online or on already discounted fees)Register 3 individuals from the same company and receive complimentary registrationfor a 4th! All 4 individuals must register and prepay at the same time – no exceptions.See page 5 for complete details.

Registration Fees If DIA cannot verify your membership upon receipt of registrationform, you will be charged the nonmember fee. Registration fee includes refreshment breaks,luncheons, and reception (if applicable), and will be accepted by mail, fax, or online.

MEMBER EARLY-BIRD OPPORTUNITY On or before AfterAvailable on nondiscount member fee only MARCH 3, 2006 MARCH 3, 2006

Member Fee US $1170 � US $1350 �

Join DIA now to qualify for the early-bird MEMBERSHIP

member fee! www.diahome.org US $ 130 �To qualify for the early-bird discount, registration form and accompanying payment must bereceived by the date above. Does not apply to government/academia/nonprofit members.

Nonmember Fee US $1480 �A one-year membership to DIA is available to those paying a NONMEMBER meetingregistration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership.

I want to be a DIA member � I do NOT want to be a DIA member �

Discount Fees MEMBER NONMEMBER*Government (Full-time) US $ 300 � US $ 430 �Charitable Nonprofit/Academia (Full-time) US $ 685 � US $ 815 �

*If paying a nonmember fee, please check one box above, indicating whether you want membership.

TUTORIALS

#1 9 am-12:00 pm US $ 350 � #3 1:00-4 pm US $ 350 �#2 9 am-12:00 pm US $ 350 � #4 1:00-4 pm US $ 350 �

#5 1:00-4 pm US $ 350 �

CANCELLATION POLICY: On or before MARCH 20, 2006Administrative fee that will be withheld from refund amount: Member or Nonmember = $200Government or Academia or Nonprofit (Member or Nonmember) = $100Tutorial = $50Cancellations must be in writing and be received by the cancellation date above.Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hoteland airline reservations. You may transfer your registration to a colleague at any timebut membership is not transferable. Please notify DIA of any such substitutions as soonas possible. Substitute registrants will be responsible for nonmember fee, if applicable.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled,DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

� I cannot attend but please keep me informed of DIA’s future events.(requires completion of name, postal address and email address on this form)

Symposium and Exhibition Delivering Quality Data ... · CDM • March 26-29, 2006 • Philadelphia...

Documents

Transcript of Symposium and Exhibition Delivering Quality Data ... · CDM • March 26-29, 2006 • Philadelphia...