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					                S O C I E T Y     F O R    C L I N I C A L    DATA M A N AG E M E N T




2007 Fall conFerence
Preliminary registration Program


                                                                                        September 16-19, 2007
                                                                                       Hyatt Regency Chicago
                                                                                              Chicago, Illinois




                                                                                                                scDm-0507-109




                                      Society for Clinical Data Management
     555 e. Wells st., suite 1100 milwaukee, Wi 53202-3823 (414) 226-0362 (414) 276-3349 (fax)   www.scdm.org
                                                        taBle oF contents
2007 Fall Conference Preliminary Registration Program



                                                          invitation to Participate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
                                                          about scDm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
                                                          scDm core Values. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
                                                          2007 Fall conference Planning committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
                                                          scDm Board of trustees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
                                                          schedule at-a-glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
                                                          Pre-conference tutorials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
                                                          leadership Forum . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
                                                          2007 Keynote Presentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
                                                          session Descriptions and Presenters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
                                                          conference information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
                                                          registration information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
                                                          special events . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
                                                          2007 sponsors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
                                                          exhibit Hall information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
                                                          2007 exhibitors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
                                                          advertising opportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
                                                          Dates to remember . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
                                                          registration Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27




                                                                                                                www.scdm.org
                                                                            inVitation to ParticiPate




                                                                                                                                 Society for Clinical Data Management, Inc. - 2007 Fall Conference
Dear colleagues,

the 13th annual Fall conference for the society for clinical Data management (scDm) will be
held in chicago, illinois from sunday, september 16th through Wednesday, september 19th at the
cosmopolitan Hyatt regency chicago, located within walking distance from michigan avenue and
navy Pier. With the help of a dedicated and hard working Fall conference committee, we have
created a program that is targeted at individuals in the discipline of clinical Data management at
various levels of experience.

the conference will kick off on monday morning with a keynote presentation entitled--
Pharmacovigilance in 2010 - What Should we be Prepared for?--by Dr. Hugo stephenson, mD,
President, Quintiles, inc., strategic research & safety. Dr. stephenson is one of the few executives
in the world who specializes in strategic research - a specialty discipline that blends knowledge of
research, marketing, law and psychology. Following regulatory approval, clinical researchers and
brand teams are continually looking at ways to determine “real world” safety through well-qualified
studies. Dr. stephenson’s recent book, Strategic Research: A Practical Handbook for Phase IIIB and
Phase IV Clinical Studies, provides an overview of study designs, advantages/disadvantages, dynamics and the value of
Phase iiiB and iV research.

additionally, prior to the conference will be an all-day leadership Forum for senior-level industry leaders, on sunday,
september 16th. Further details can be found at www.scdm.org.

there will be two tutorials offered at the Fall conference, both of which are full-day (six hour) intensive training sessions.
the first, offered on saturday, september 15th, will provide an introduction to coding. our second tutorial will take place
on sunday, september 16th and focus on managing lab Data.

the exhibit hall and conference schedule will provide attendees dedicated time to meet with all of our exhibiting vendors.
in addition, this year we are introducing the SCDM “Data Driven” Innovation Awards. this new program will give service
and technology providers an opportunity to highlight innovative solutions they have developed with their customers to meet
the needs of clinical Data management organizations.

the 13th annual conference will conclude at noon on Wednesday, september 19th.

Please join us in chicago for the scDm 13th annual conference. We look forward to meeting you and learning about your
vision of clinical Data management in the future.

sincerely,




Paul clarkson, ccDm and ralph russo
conference co-chairs




  Questions? Please contact the scDm administrative office at (414) 226-0362 or email: marnold@scdm.org                                        
                                                        society For clinical Data management
2007 Fall Conference Preliminary Registration Program

                                                        Data DriVen

                                                        aBoUt scDm

                                                        scDm is a non-profit professional society founded in 1994 to advance the discipline of clinical data management.

                                                        scDm consists of over 1600 data management professionals. Positions held by members within their respective
                                                        organizations range from President to associate. members are from pharmaceutical companies, biotechnology firms,
                                                        clinical research organizations, software and hardware vendors, academia, consulting firms and more. all top
                                                        pharmaceutical companies are represented, as are all regions of the United states, canada, europe, and the asia Pacific
                                                        region. the common thread binding these individuals together is a commitment to promoting quality and excellence in the
                                                        clinical data management profession.

                                                        scDm and its members pave the way to advancing the discipline through activities such as formally certifying clinical
                                                        data management professionals, setting clinical data management standards and processes through the continued
                                                        development of the good clinical Data management Practices (gcDmP), providing publications, and offering
                                                        opportunities for education and professional networking.

                                                        Whether you are just starting out or you are a seasoned data management professional, scDm provides the road map
                                                        and the vehicle that will help you reach your destination within the clinical data management industry.

                                                        Fall conFerence target aUDience
                                                        this conference will benefit those in the fields of clinical data management, clinical information technology, regulatory,
                                                        systems validation, biostatistics, and industry service providers. over 550 professionals attended the 2006 Fall
                                                        conference.




                
                                           society For clinical Data management




                                                                                                                              Society for Clinical Data Management, Inc. - 2007 Fall Conference
                                                                                                          Data DriVen

scDm core ValUes
KnoWleDge anD exPerience oF oUr memBers
the intellectual capital and collective experience of our members are our greatest assets. We rely on and embrace the
participation and contributions of our members and volunteers.

scHolarsHiP
We encourage and promote rigor and discipline in the research of topics affecting our industry. our positions, publications
and programs will be the result of scholarly investigation.

QUality anD continUoUs imProVement
We are committed to the development and enhancement of products, services and relationships of the highest quality.

oPen commUnication
We encourage open communication and information sharing. We provide our members with insight to the organization’s
initiatives and activities.

integrity
We exemplify and expect honesty and integrity.

oUr coDe oF etHics
clinical Data management is a key component of the development of new medications, medical procedures and devices.
clinical Data management professionals are:

• Committed to following the laws and guidelines applicable to clinical research (including the Declaration of Helsinki),
  to participate in the protection of the safety, dignity and well being of patients and to maintain the confidentiality of
  medical records.
• Committed to creating, maintaining and presenting quality clinical data, thus supporting accurate and timely statistical
  analysis, and to adhering to applicable standards of quality and truthfulness in scientific research.
• Committed to facilitating communication between clinical data management professionals and all other clinical
  research professionals, to maintaining competency in all areas of clinical data management, to keeping current with
  technological advances, and to ensuring the dissemination of information to members of the clinical research team.
• Committed to working as an integral member of a clinical research team with honesty, integrity and respect. to
  making and communicating accountability for clinical data management decisions and actions within the clinical trial
  process.
• Committed to maintaining and respecting proprietary knowledge at all levels, to avoiding the use of proprietary
  knowledge for personal gain, and to disclosing any conflict of interest. to avoiding any conduct or behavior that is
  unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management.
• Committed to advancing the profession of clinical data management through the development, distribution and
  improvement of good clinical data management practices; to aiding the professional development and advancement
  of colleagues within the clinical trial industry.




                                                                                                                                            
                                                        2007 Fall conFerence Planning committee
2007 Fall Conference Preliminary Registration Program



                                                        Paul Clarkson, CCDM        Co-Chair    Susan Howard               Member    Leigh Smith, CCDM          Member
                                                        genentech, inc.                        glaxosmithKline Pharmaceuticals      shire Development, inc.
                                                        south san Francisco, ca                collegeville, Pa                     collegeville, Pa
                                                        clarkson.paul@gene.com                 susan.k.howard@gsk.com               lesmith@shire.com

                                                        Ralph Russo                Co-Chair    Debra Jendrasek             Member   Pat Stetser, CCDM          Member
                                                        schering Plough research institute     chiltern international               accenture
                                                        Kenilworth, nJ                         Berwyn, Pa                           collegeville, Pa
                                                        ralph.russo@spcorp.com                 debra.jendrasek@chiltern.com         stetsep@wyeth.com

                                                        Marcia Brackman, CCDM Member           Susan Kozak               Member     Pati Stone                   Member
                                                        eli lilly and company                  Wyeth                                DatatraK international, inc.
                                                        indianapolis, in                       collegeville, Pa                     raleigh, nc
                                                        brackman_marcia@lilly.com              kozaks@wyeth.com                     pati.stone@datatrak.net

                                                        Rennie Castelino, CCDM Member          Michelle Meany              Member   Leslie Vallée              Member
                                                        genentech, inc.                        schering Plough research institute   genentech, inc.
                                                        south san Francisco, ca                Kenilworth, nJ                       south san Francisco, ca
                                                        castelino.rennie@gene.com              michelle.meany@spcorp.com            vallee.leslie@gene.com

                                                        Carolina Cubillos            Member    Marianne Plaunt, PhD        Member   Demetris Zambas             Member
                                                        schering Plough research institute     i3 statprobe                         schering Plough research institute
                                                        Kenilworth, nJ                         ann arbor, mi                        Kenilworth, nJ
                                                        carolina.cubillos@spcorp.com           marianne.plaunt@i3statprobe.com      demetris.zambas@spcorp.com

                                                        Charlene Dark, CCDM           Member   Jessica Scott             Member     Vesna Zovkic               Member
                                                        statistics & Data corporation          ascenta therapeutics                 DePuy orthopaedics, a Johnson &
                                                        raleigh, nc                            san Diego, ca                        Johnson company
                                                        cdark@statisticsanddata.com            jscott@ascenta.com                   Warsaw, in
                                                                                                                                    vzovkic@dpyus.jnj.com
                                                        Brenda Hoeper              Member
                                                        Quintiles, inc.
                                                        cincinnati, oH
                                                        brenda.hoeper@quintiles.com




                
                                                                  scDm BoarD oF trUstees




                                                                                                                      Society for Clinical Data Management, Inc. - 2007 Fall Conference
Anthony Costello, CCDM       Chair    Paul Clarkson, CCDM           Trustee    Derek Perrin                 Trustee
nextrials, inc.                       genentech, inc.                          Pfizer global research and
san ramon, ca                         south san Francisco, ca                  Development
costello@nextrials.com                clarkson.paul@gene.com                   new london, ct
                                                                               derek.perrin@pfizer.com
Jonathan Andrus, CCDM Vice-Chair      Charlene Dark, CCDM           Trustee
Phoenix Data systems                  statistics & Data corporation            Linda Talley                 Trustee
King of Prussia, Pa                   raleigh, nc                              eli lilly and company
jandrus@pdsedc.com                    cdark@statisticsanddata.com              indianapolis, in
                                                                               talley_linda_m@lilly.com
Pamela Norton,CCDM    Treasurer       Mary Foy, CCDM                 Trustee
Pharmanet, inc.                       Duke clinical research institute         Jill Vath               Past Chair
cary, nc                              Durham, nc                               genentech, inc.
pnorton@pharmanet.com                 mary.foy@duke.edu                        south san Francisco, ca
                                                                               vath.jill@gene.com
Colleen Cox, CCDM         Secretary   Karen Hicks, CCDM            Trustee
PrometriKa, llc                       sirion therapeutics
cambridge, ma                         tampa, Fl
collmcox@yahoo.com                    khicks@siriontherapeutics.com



scDm committee cHairs
Certification Committee               External Relations Committee             Membership Committee
leigh smith, ccDm                     Jonathan andrus, ccDm                    Deborah cole, ccDm
shire Development, inc.               Phoenix Data systems                     Quintiles, inc.
collegeville, Pa                      King of Prussia, Pa                      cincinnati, oH
lesmith@shire.com                     jandrus@pdsedc.com                       deborah.cole@quintiles.com

Vesna Zovkic                          Marketing Committee                      Publications Committee
DePuy orthopaedics, a Johnson &       Jim Dorsey                               lynda Hunter, ccDm
Johnson company                       Phoenix Data systems                     Pra international
Warsaw, in                            King of Prussia, Pa                      raymore, mo
vzovkic@dpyus.jnj.com                 jdorsey@pdsedc.com                       hunterlynda@praintl.com

Education Committee                   Good Clinical Data Management
ellen coull, ccDm                     Practices (GCDMP) Committee
Pra international                     carol garvey
Hazlett, nJ                           genentech, inc.
coullellen@praintl.com                south san Francisco, ca
                                      garvey.carol@gene.com




                                                                                                                                    
                                                        Preliminary Fall conFerence scHeDUle at-a-glance
2007 Fall Conference Preliminary Registration Program



                                                        satUrDay, sePtemBer 15, 2007
                                                          8:00 a.m. - 5:00 p.m.        scDm Board of trustees meeting
                                                          8:00 a.m. - 4:30 p.m.        Pre-conference tutorial: introduction to coding (separate registration fee)

                                                        sUnDay, sePtemBer 16, 2007
                                                          7:00 a.m.   -   8:00 p.m.    registration open
                                                          8:30 a.m.   -   4:00 p.m.    leadership Forum (separate registration fee)
                                                          8:00 a.m.   -   4:30 p.m.    Pre-conference tutorial: managing lab Data (separate registration fee)
                                                         12:00 p.m.   -   5:00 p.m.    exhibitor move-in
                                                          6:30 p.m.   -   8:00 p.m.    opening reception in the exhibit Hall

                                                        monDay, sePtemBer 17, 2007
                                                          7:00 a.m.   -   7:00 p.m.    registration open
                                                          7:30 a.m.   -   8:30 a.m.    continental Breakfast
                                                          8:30 a.m.   -   9:00 a.m.    scDm Business meeting & awards ceremony
                                                          9:00 a.m.   -   10:00 a.m.   Keynote Presentation: Pharmacovigilance in 2010 - What should we be Prepared for?
                                                                                       Dr. Hugo stephenson, mD, President, Quintiles, inc., strategic research & safety
                                                         10:00 a.m. - 5:00 p.m.        exhibit Hall open
                                                         10:00 a.m. - 10:30 a.m.       morning Break in the exhibit Hall
                                                         10:30 a.m. - 12:00 p.m.       session ia: contents of a Data management Plan: identifying and managing the
                                                                                       challenges of content and a comparison/contrast of the DmP for Paper & eDc
                                                                                       studies
                                                                                       session iB: electronic Health records
                                                         12:00 p.m. - 1:30 p.m.        Box lunch in the exhibit Hall, sponsored by
                                                         12:00 p.m. - 1:00 p.m.        certification luncheon, sponsored by
                                                          1:30 p.m. - 3:00 p.m.        session iia: cDm Working relationships i
                                                                                       session iiB: evolving cro/sponsor Partnership models in a changing
                                                                                       Business environment
                                                                                       session iic: Working session on the cDisc chapter addition to the good clinical Data
                                                                                       management Practices (gcDmP) Document
                                                          3:00 p.m. - 3:30 p.m.        afternoon Break in the exhibit Hall, sponsored by
                                                          3:30 p.m. - 5:00 p.m.        session iiia: metrics for eDc studies
                                                                                       session iiiB: surviving audits
                                                          5:30 p.m. - 7:00 p.m.        networking event




                
           Preliminary Fall conFerence scHeDUle at-a-glance




                                                                                                                Society for Clinical Data Management, Inc. - 2007 Fall Conference
tUesDay, sePtemBer 18, 2007
  7:00 a.m. - 6:00 p.m.    registration open
  7:30 a.m. - 8:30 a.m.    continental Breakfast
  8:30 a.m. - 10:00 a.m.   session iVa: managing cro/sponsor relationships
                           session iVB: resource Planning
 10:00 a.m. - 3:30 p.m.    exhibit Hall open
 10:00 a.m. - 10:30 a.m.   morning Break in the exhibit Hall, sponsored by
 10:30 a.m. - 12:00 p.m.   session Va: metrics for outsourced studies
                           session VB: cDm in late Phase studies and registries
 12:00 p.m. - 1:30 p.m.    Box lunch in the exhibit Hall
  1:30 p.m. - 3:00 p.m.    session Via: cDm Working relationships ii
                           session ViB: Vendor Qualification
  3:00 p.m. - 3:30 p.m.    afternoon Break in the exhibit Hall
  3:30 p.m. - 5:00 p.m.    session Viia: managing the Data management Plan: managing creation, maintenance of
                           the Data management Plan and Facilitating Documentation outcome
                           session ViiB: regulatory issues
  3:30 p.m. - 11:59 p.m.   exhibitor move-out
           5:00 p.m.       evening on your own

WeDnesDay, sePtemBer 19, 2007
  7:00 a.m. - 12:00 p.m.   registration open
  7:30 a.m. - 8:30 a.m.    continental Breakfast
  8:30 a.m. - 10:00 a.m.   session Viiia: Data standards
                           session ViiiB: cDm in Device trials
 10:00 a.m. - 10:30 a.m.   Break—attendee hotel check-out
 10:30 a.m. - 12:00 p.m.   session ixa: the Data manager/Database Developer relationship
                           session ixB: Data Quality control and audits in eDc studies
          12:00 p.m.       conference adjourns for 2007




                                                                                                                              
                                                        Pre-conFerence tUtorials
2007 Fall Conference Preliminary Registration Program



                                                        Presented by the Society for Clinical Data Management, in collaboration with the Duke Clinical Research Institute.

                                                        register for both tutorials for $900; a savings of $90.


                                                        satUrDay, sePtemBer 15, 2007                                    sUnDay, sePtemBer 16, 2007
                                                        8:00 a.m. - 4:30 P.m.                                           8:00 a.m. - 4:30 P.m.
                                                        Pre-Conference Tutorial:                                        Pre-Conference Tutorial:
                                                        Introduction to Coding                                          Managing Lab Data
                                                        Presented by: Betsy Thomas, RN, Coding Specialist, Duke         Presented by: Arleen Eppinger, CCDM, Clinical Data
                                                        Clinical Research Institute                                     Specialist, Duke Clinical Research Institute

                                                        this introductory training session is intended for those who    effective management of laboratory data is critical to
                                                        have an understanding of clinical data flow and will have       the conduct of clinical trials. this tutorial will provide
                                                        responsibility for coded data. examples of commonly coded       clinical data managers with an opportunity to develop the
                                                        data include adverse events and concomitant medications         knowledge needed to meet a variety of study requirements.
                                                        that are part of a trial database managed in a clinical Data    considerations in managing local, central and point of care
                                                        management system (cDms). the instructor will review:           lab data will be covered. this tutorial will include practical
                                                        common coding dictionaries (controlled terminologies),          exercises using a mock study protocol.
                                                        considerations for when coding terms in a clinical trial,
                                                                                                                        Upon completion of the training, participants should be able
                                                        and designing workflow for the ongoing coding process.
                                                                                                                        to…
                                                        the session will include demonstrations using a cDms
                                                                                                                        • Describe how the unique issues of lab data collection
                                                        coding tool and participant exercises to reinforce learning
                                                                                                                          impacts data management
                                                        objectives. group discussions will be facilitated to benefit
                                                        from common experiences and practices used across               • Define lab data collection plans for a clinical trial
                                                        organizations.                                                  • list the lab requirements of the scope of work and the
                                                                                                                          protocol
                                                        Upon completion of the training, participants should be
                                                                                                                        • identify different types of laboratories used in clinical trials
                                                        able to…
                                                                                                                        • list common lab tests and groups
                                                        • Discuss standard event and medication controlled
                                                                                                                        • Discuss how vendor relationships impact lab data
                                                          terminologies; including basic statistics, structure of the
                                                                                                                          management
                                                          dictionaries and how versions are managed
                                                                                                                        • Describe regulations and standards that impact labs and
                                                        • explain how new versions are applied to the cDms and
                                                                                                                          lab data
                                                          how this affects coded data
                                                                                                                        • Describe how units and reference ranges impact lab data
                                                        • Discuss situations where lexical variants are added,
                                                                                                                          management
                                                          codes are inactivated, or codes are reassigned
                                                                                                                        • compose a quality control processes for lab data
                                                        • explain the pros and cons of updating a coding diction-
                                                          ary mid study                                                 Tutorial fee: $495
                                                        • Understand workflow (algorithms) for auto-encoding and        Separate registration required.
                                                          interactive (manual) coding
                                                        • Write coding guidelines and convention
                                                        • specify coding consistency reports

                                                        Tutorial fee: $495
                                                        Separate registration required.
      10
                                                                                             leaDersHiP ForUm




                                                                                                                                 Society for Clinical Data Management, Inc. - 2007 Fall Conference
Data stanDarDs anD tecHnology - Past, Present anD FUtUre
sUnDay, sePtemBer 16, 2007
8:30 a.m. – 4:00 P.m.
Do data standards keep you up at night? Do you see cDisc in your coffee cup? Hear esource in your iPod?

if so, the 2007 society for clinical Data management leadership Forum is designed for you. Join your peers in a
meaningful, results-driven dialogue about the challenges and opportunities involved in the implementation of data
standards. through participation in Data standards and technology – Past, Present and Future, you and other industry
leaders, will help bring clarity and understanding to the Data management profession on this critical topic.

Beginning with an historical overview from experts in the discipline of Data standards, you will gain a better appreciation of
the path that led us to this important period in our industry.
general session Presenters include:
Clement McDonald, MD, Director of lister Hill center, national library of medicine, national institutes of Health
and Carl Kraus, MD, senior Director, infectious Diseases, i3research and Vice President, i3global technology

then, forum participants will hear from a variety of organizations (e.g. cro, Pharma, technology vendor, etc.) on how they
have interpreted the standardization movement and how they have implemented changes to date. this important session
will feature peer discussion on:

• How will new technology and data standards change data management?
• What kind of process and organizational changes are recommended to take place to ensure successful implementation?
• What is the effect on a business when adopting data standards?
• are there different interpretations of where data and technology standardization will take us?
• can companies take different paths and still be successful?
• How can you best ensure your organization is knowledgeable about the industry changes?
• can a better dialogue and understanding be had across the profession? How can scDm facilitate?
• How can continued changes and discoveries be communicated and shared?

Forum Facilitators include:
Anthony Costello, CCDM ,Vice President, Product Development and Data services, nextrials, inc.
Suzanne Lamerand, Vice President, Data management, Dsg, inc.
Ginger Kessing, senior Director, clinical Data management, Quintiles, inc.
Michael Luker, manager, medical informatics, eli lilly and company
Regina Nye, Director of Dictionaries and standards, global clinical Data services, Pfizer, inc.
Landen Bain, cDisc liaison to Healthcare, clinical Data interchange standards consortium (cDisc)

the leadership Forum is designed for 80 people and will allow for time for informal discussion in addition to the
presentations and group discussions.

those that would benefit most from this discussion are individuals who:
• Have director, managerial or supervisory responsibilities
• Have input and been involved in the strategic direction of their department and/or organization with regard to standards
and technology.

the cost to attend the leadership Forum is $250, which includes all session materials, continental breakfast, lunch and
two breaks. those attending both the leadership Forum and the 2007 scDm Fall conference will receive a reduction in
fee of $50.                                                                                                                        11
                                                        session DescriPtions anD Presenters
2007 Fall Conference Preliminary Registration Program



                                                        monDay, sePtemBer 17, 2007
                                                        9:00 a.m. - 10:00 a.m.
                                                                                         Keynote Presentation: Pharmacovigilance in 2010 - What Should we be Prepared
                                                                                         for?
                                                                                         Dr. Hugo stephenson, mD, President, Quintiles, inc., strategic research & safety
                                                                                           Dr. Hugo stephenson established Quintiles strategic research services (srs), now strategic
                                                                                           research & safety, in 2003 to consolidate Quintiles’ non-registration research services across north
                                                                                           america, europe, asia/Pacific and Japan. Quintiles strategic research services is a leading provider
                                                                                           of global Phase iiiB and iV research activities, working with a wide range of major pharmaceutical
                                                                                           companies. Dr. stephenson recently authored a new book: “strategic research: a Practical Handbook
                                                                                           for Phase iiiB and Phase iV clinical studies” to help pharmaceutical and biotech companies conduct
                                                                                           research on competitive positioning and post-marketing safety research for their products. Dr.
                                                                                           stephenson calls this type of research “strategic research” to differentiate it from the basic safety
                                                        and efficacy studies required for FDa approval. Dr. stephenson is one of the few executives in the world who specializes in strategic
                                                        research - a specialty discipline that blends knowledge of research, marketing, law and psychology. Following regulatory approval,
                                                        clinical researchers and brand teams are continually looking at ways to determine “real world” safety through well-qualified studies. Dr.
                                                        stephenson’s book provides an overview of study designs, advantages/disadvantages, dynamics and the value of Phase iiiB and iV
                                                        research.


                                                        10:30 a.m.-12:00 P.m.
                                                        Session IA: Contents of a Data Management Plan:                      Session IB: Electronic Health Records
                                                        Identifying and Managing the Challenges of Content                   session chair: Debra Jendrasek, Head, US EDC Solutions,
                                                        and a Comparison/Contrast of the DMP for Paper &                     Chiltern International
                                                        EDC Studies
                                                        session chair: Rennie Castelino, CCDM, Manager, Clinical             this session is an update from last year’s scDm fall conference
                                                        Data Management, Genentech, Inc.                                     on the future use of eHr data in clinical research. since that time,
                                                                                                                             several “use cases” have been developed and demonstrated.
                                                        this session will be an exploration of Data management Plan          During this session we will learn from examples of scenarios
                                                        (DmP) content. During this session we will learn about relevant      where data collected in eHr is used in other systems and will
                                                        content, impacts of regulations and study decisions on content       see an actual demonstration where clinical research is done
                                                        as well as the rationale for inclusion of certain content. We        within an eHr environment. Join us to learn the background for
                                                        will consider DmP types and associated content for various           this demonstration and for an update on the recent, cutting edge
                                                        resourcing models (sponsor only, co-management between               technology (rFD profile),and where we go from here including an
                                                        sponsor & cro and cro-only with sponsor oversight). We will          update on concrete items for furthering eHr in clinical trials.
                                                        also learn about DmP content in a comparison / contrast format
                                                        for Paper & eDc studies. session attendees will learn these key      Presenters Include:
                                                        planning concepts for clinical Data management in clinical trials.   Linda King, Global Clinical Data Mgmt Team Leader, Center for
                                                                                                                             Process Expertise, Eli Lilly and Co.
                                                        Contents of Data Management Plan                                     Landen Bain, Healthcare Liaison, CDISC
                                                        Anuprita Sheth, Program Manager (Operation Leader),
                                                        Cognizant Technology Solutions
                                                        Data Management Plans
                                                        Nimita Limaye, CCDM, Head, Data Management
                                                        (CDM & Biometrics), SIRO Clinpharm Pvt. Ltd
                                                        Data Management Planning for EDC Studies
                                                        Jonathan Andrus, CCDM, VP, QA and Clinical Data Management,
                                                        Phoenix Data Systems, Inc.
      1
                                                session DescriPtions anD Presenters




                                                                                                                                          Society for Clinical Data Management, Inc. - 2007 Fall Conference
monDay, sePtemBer 17, 2007
1:30 P.m. - 3:00 P.m.
Session IIA: CDM Working Relationships I                             Session IIB: Evolving CRO/Sponsor Partnership
session chair: Marcia Brackman, CCDM,                                Models in a Changing Business Environment
Associate Clinical Data Management Consultant,                       session chair: Leigh Smith, CCDM,
Eli Lilly and Company                                                Associate Director Clinical Data Management,
With the continually evolving role of the clinical data manager,     Shire Development, Inc.
it is imperative to establish productive working relationships       clinical Data management is hardly immune from the changing
with both our internal and external counterparts, specifically       shifts in the pharmaceutical industry, whether they be operational
clinical operations. this session will discuss how to establish an   or global. this session examines both how these shifts affect
effective cross-functional team to allow for open communication      the relationship between contract research organizations and
and to establish consistent and standardized processes for           sponsors, as well as how specifically models of cro/sponsor
issue communication, data review, and clinical endpoint trial        Partnerships can proactively address how these shifts will
management.                                                          impact one’s organization. attendees will hear from a group of
Collaboration of Data Management and Clinical Operations             representatives from both cros and sponsors who discuss how
in the Management of a Clinical Endpoint Trial                       they implemented a new Partnership model, which paired the
Suellen Bertram, Clinical Data Manager Coordinator,                  sponsor’s cro partners down from 12 to just two. additionally,
Eli Lilly and Company                                                the session will address how changes on an international level are
                                                                     impacting the relationship between sponsors and cros.
How to Review & Clean 70 Million Data Points - A Success
Story of Cross-Functional Data Review                                Sponsor - CRO Partnerships
Susan Krikorian, CCDM, Senior Manager,                               Armand Matejunas, Sr. Director, Global Clinical Information &
Data Management, CV Therapeutics                                     Data Management, Shire Development, Inc.
                                                                     Jeanne Ashton, VP, Data Management, PharmaNet Inc.
The Successful Team: Clinical Data Management and
                                                                     David Wignall, Director, Clinical Data Management, PRA
Clinical Trial Management
                                                                     International
Sherri DeGiorgio, Practice Lead, Eliassen Group
                                                                     Change in the Pharmaceutical Market – Impacts and Effects
                                                                     on the Sponsor-CRO Relationship in Data Management
                                                                     Markus Klose, Senior Database Programmer, Accovion GmbH




  Session IIC: Working Session on the CDISC Chapter Addition to the Good Clinical Data Management
  Practices Document (GCDMP)
  session chair: Dr. Khaled el-emam, chief scientist,
  trialstat corporation

  this workshop is the first meeting of the cDisc/standards task force. the objective of the task force is to identify and document
  how cDisc-developed (and other standards) impact data management, and provide input into how this can be addressed in the
  gcDmP. our first meeting will define the scope and work plan for the task force and outline the method by which the task force will
  address the topic of standards in the gcDmP. it is hoped that many of the participants in this session will continue on to become
  members of the task force and work toward the development of meaningful and useful gcDmP content for data management
  professionals. this will be a working session where small groups will discuss together and then provide a group debrief with their
  ideas to the group at large.

  Please note this session is limited to the first 60 people.

                                                                                                                                            1
                                                        session DescriPtions anD Presenters
2007 Fall Conference Preliminary Registration Program



                                                        monDay, sePtemBer 17, 2007
                                                        3:30 P.m. - 5:00 P.m.
                                                        Session IIIA: Metrics for EDC Studies                             Session IIIB: Surviving Audits
                                                        session chair: Demetris Zambas, Associate Director,               session chair: Susan Howard, Assistant Director,
                                                        GCDM, Schering Plough Research Institute                          GlaxoSmithKline Pharmaceuticals
                                                        Performance metrics can be viewed as the mirror through which     the Pharmaceutical industry is under intense scrutiny by the
                                                        an organization can observe its current and past performance.     public and governmental agencies. increasingly, more and
                                                        With the advent of eDc a broader spectrum of metrics can be       more of us will find ourselves in the situation of being audited
                                                        collected, consolidated and reported to facilitate tactical and   by regulatory agencies at least in part due to this scrutiny. the
                                                        strategic decision making. this session will demonstrate the      speakers in this session will provide three unique perspectives
                                                        potential operational knowledge contained within eDc databases    on auditing. a seasoned survivor of numerous FDa, emea
                                                        as well as examples of how various cDm organizations have         and Health canada audits will provide strategies for preparing
                                                        been able to leverage this valuable resource.                     for audits and audit tips. an vendor will provide an overview of
                                                                                                                          information technology (it) Best Practices and give a step-by-
                                                        EDC Metrics: The Ultimate Proof of Full Utilization of EDC
                                                                                                                          step approaching to hosting a successful external it audit. the
                                                        Functionality
                                                                                                                          third speaker (invited) is a seasoned FDa auditor. you will hear
                                                        Teresa Ancukiewicz, Senior Manager, Data Management, Boston
                                                                                                                          information that will be applicable to your every day job and will
                                                        Scientific Corporation
                                                                                                                          prepare you for an audit on your study.
                                                        Metrics for EDC Studies
                                                                                                                          Best IT Practices When Preparing for an External Audit
                                                        Marysasser Holloway, Director and Derek Campbell, Manager,
                                                                                                                          Earl Hulihan, Vice President, Global Regulatory Affairs and
                                                        Clinforce, LLC
                                                                                                                          Quality Assurance, Medidata Solutions
                                                        Metrics for EDC Studies
                                                                                                                          The Art of Succesful Audit Survival
                                                        Stefanie Alfano, Manager, Schering Plough Research Institute
                                                                                                                          Scott Chase, QA Team Lead, BLCPro
                                                                                                                          With an additional presentation from:
                                                                                                                          Michael Rashti, Consumer Safety Officer,
                                                                                                                          Investigations Branch of the U.S. Food and Drug Administration




      1
                                                 session DescriPtions anD Presenters




                                                                                                                                                Society for Clinical Data Management, Inc. - 2007 Fall Conference
tUesDay, sePtemBer 18, 2007
8:30 a.m. - 10:00 a.m.
Session IVA: Managing CRO/Sponsor Relationships                          Session IVB: Resource Planning
session chair: Charlene Dark, CCDM, Director, Data                       session chair: Leslie Vallée, Senior Manager, Clinical Data
Management, Statistics and Data Corporation                              Management, Genentech, Inc.
“i’m already managing the data, now i need to manage the                 resource planning is a critical activity for all cDm departments. in
relationship with my cro or sponsor?!” no matter what side               this session we will discuss:
(cro or sponsor) of clinical Data management you are                     • How can we determine the resources we need? What are the
on, managing the relationship with the other side can be an                 questions we need to ask and what information do we need to
increasing part of your daily job. this session will discuss different      know to estimate resources?
methods and scenarios of optimizing these partnerships.                  • What are some common approaches to resource planning?
                                                                            What are the advantages and disadvantages of having special-
CRO/Sponsor Relationships: “We Can Work It Out” -
                                                                            ist or generalist data managers?
Successfully Managing a Difficult Study
                                                                         • What tools are cDm departments using to plan resources?
Marina Kelly, Manager, Data Management and
                                                                            How are the tools validated? a case study will show how one
Martha Johnson, Manager, Data Management,
                                                                            cDm department adapted its resource planning tool to a divi-
PharmaNet, Inc.
                                                                            sion-wide tool.
Niche Development Operations Support Organization and
                                                                         Resource Planning and Models at TAP R&D
Relationship Management, Working with a Large Sponsor
                                                                         Judith Kasperczyk, CCDM, Director,
Kevin Hurley, Partner, BLCPro
                                                                         Clinical Data Management, Abbott Laboratories
CRO vs. Sponsor- The Love/Hate Relationship of All Time.
                                                                         How Can I Predict the Time and Resources Needed for
Why Do These Two Groups Need to be at Such
                                                                         Clinical Data Management to Set Up and Conduct
Opposing Odds?
                                                                         a Clinical Study?
michelle Harrison, manager, clinical Data management, coley
                                                                         Lori Venable, Principal Consultant, BioPharm Systems, Inc
Pharmaceutical group
                                                                         Data Management Resource Planning: Specialist or
                                                                         Generalist Approach?
                                                                         Jennifer Duggan, CCDM, Manager, Clinical Data Management,
                                                                         Allied Research International




                                                                                                                                                  1
                                                        session DescriPtions anD Presenters
2007 Fall Conference Preliminary Registration Program




                                                        tUesDay, sePtemBer 18, 2007
                                                        10:30 a.m. - 12:00 P.m.
                                                        Session VA: Metrics for Outsourced Studies                           Session VB: CDM in Late Phase Studies and
                                                        session chair: Carolina Cubillos, Associate Director,                Registries
                                                        Clinical Data Management,                                            session chair: Brenda Hoeper, Proposal Manager,
                                                        Schering Plough Research Institute                                   Quintiles, Inc.
                                                        the use of good metrics is a must for the successful conduct         is it true? are they really different? that different? Do late phase,
                                                        and cost/performance management of clinical trials. this session     registry and observational trials really present challenges different
                                                        will specifically focus on the use of metrics for outsourced         from Phase i, ii and iii trials? aren’t they easier (and cheaper)
                                                        clinical trials and the role metrics can play in ensuring quality,   to execute from a data management perspective? attend this
                                                        performance, collaboration and program success.                      session to learn the realities of managing data for late phase,
                                                                                                                             observational and registry studies. learn about how technology
                                                        Setting the Bar on Metrics
                                                                                                                             can be leveraged to increase efficiency and reduce costs, about
                                                        Carol Garvey, Associate Director, Genentech, Inc.
                                                                                                                             special challenges regarding regulatory and safety issues, and
                                                        Metrics for Outsourced Studies: An Integrated Approach               about the challenges associated with the long-term duration of
                                                        Nicole Duffey, Senior Operations Manager, Clinical Data              some of these trials.
                                                        Management and Michael Wright, Senior Director, Biometrics,
                                                                                                                             EDC Strategies for Phase IV Trials
                                                        ReSearch Pharmaceutical Services, Inc.
                                                                                                                             John Simpson, Director, Product Strategy, TrialStat Corporation
                                                        Phase-Specific Measures to Determine CRO Performance:
                                                                                                                             Long Term Observational Trials: Managing the Challenges of
                                                        A CRO Perspective
                                                                                                                             Study Technology Change
                                                        Kelly Ritch, Clinical Data Project Manager, Rho, Inc.
                                                                                                                             Kathy Haag, CCDM, Associate Clinical Data Management
                                                                                                                             Consultant, Eli Lilly and Company
                                                                                                                             Facing the Challenges of Late Phase Trials: A Case Study
                                                                                                                             Jamie Hahn, Clinical Data Project Manager and
                                                                                                                             Allison Fowlkes, Clinical Data Project Manager, Rho, Inc.




      1
                                                 session DescriPtions anD Presenters




                                                                                                                                              Society for Clinical Data Management, Inc. - 2007 Fall Conference
tUesDay, sePtemBer 18, 2007
1:30 P.m. - 3:00 P.m.
Session VIA: CDM Working Relationships II                               Session VIB: Vendor Qualification
session chair: Dr. Marianne Plaunt, PhD, Vice President,                session chair: Jessica Scott, Senior Manager, Clinical Data
Data Management, i3 Statprobe                                           Management, Ascenta Therapeutics
this session will discuss different solutions to bring together         With the fast-paced and technologically-advanced industry that
the clinical and technical sides of data management. With the           we are a part of, more and more companies are moving towards
increasing use of eDc, it is critical that there is an effective        outsourcing various tasks or functional areas and exploring new
communication flow between cDm, programmers, and Biostatics             technologies. so, your company has now decided to outsource
to ensure quality and consistency in the clinical trial data.           a task, or maybe it’s time to consider eDc, ePro, a safety
the presentations will address ways to establish this working           database, or iVrs. Where does one begin trying to assess the
relationship, including the creation of specific groups to facilitate   many different vendors, and how does one decide on the vendor
and establish best practices.                                           that is just right for his or her departmental and organizational
Information Central: CDM’s Role in EDC Trials                           needs? this session will answer these questions, from the
Michael Lozano, Associate Clinical Data Management                      viewpoints of sponsors, vendors, and it. the presentations will
Consultant, Eli Lilly and Company                                       address the role and leadership of clinical data management in
                                                                        the qualification and selection of various vendors, as well as the
The Soul of a New Technology: Working Relationships                     key factors to consider when selecting an eDc, ePro, or other
Across a Technologically Connected Process                              it vendors. it promises to be filled with key take home points that
Carolina Cernadas, Project Manager Clinical Data Management,            can be put to use immediately when making those important
Schering Plough Argentina                                               decisions!
Why CDM Working Relationships with Programming and                      The Role of Clinical Data Management in the
Biostats are the Key to Success                                         Qualification of Vendors
Nicole Gallegos, Data Management,                                       Kristan Gallitano, Director Data Management, Eliassen Group
Schering Plough Research Institute
                                                                        Clinical Data Management Leadership in Qualifying and
                                                                        Selecting an ePRO Vendor
                                                                        David Borbas, Associate Director, Data Management,
                                                                        Jazz Pharmaceuticals, Inc.
                                                                        Developing Criteria for EDC Vendor Selection
                                                                        Jennifer Price, CCDM, Senior Director, Clinical Systems,
                                                                        Phoenix Data Systems
                                                                        IT Vendor Selection
                                                                        Michelle Zubatch, Director of Business Development,
                                                                        BioPharm Systems




                                                                                                                                                1
                                                        session DescriPtions anD Presenters
2007 Fall Conference Preliminary Registration Program



                                                        tUesDay, sePtemBer 18, 2007
                                                        3:30 P.m. - 5:00 P.m.
                                                        Session VIIA: Managing the Data Management                        Session VIIB: Regulatory Issues
                                                        Plan: Managing Creation, Maintenance of the Data                  session chair: Pati Stone, Senior Consultant,
                                                        Management Plan and Facilitating Documentation                    Enterprise Consulting, DATATRAK International, Inc.
                                                        Outcome
                                                                                                                          regulations affect every aspect of our daily work and so it is fitting
                                                        session chair: Rennie Castelino, CCDM, Manager,
                                                                                                                          that in this session we will hear three diverse presentations. the
                                                        Clinical Data Management, Genentech, Inc.
                                                                                                                          presentations will discuss the best methods to decommission an
                                                        this session will focus on the activities and tasks involved in   eDc study, clinical data security compliance using encryption,
                                                        managing the ‘living’ content of a Data management Plan (DmP).    and medDra coding strategy in readiness for regulatory review.
                                                        During this session we will learn about the development cycle
                                                                                                                          How Secure is Secure – Taking Data Encryption
                                                        of a DmP and how it may be expedited considerably. We will
                                                                                                                          to the Next Level
                                                        consider prospective planning, documenting agreements and
                                                                                                                          Peter O’Blenis, VP Product Manager, TrialStat Corporation
                                                        versioning (in sections or as a whole) of the DmP. We will also
                                                        consider efficiencies involved in using the DmP to facilitate     Study Decommissioning, Order or Chaos: Best Practice
                                                        management of clinical data management study documentation.       Methods to Meet FDA’S Records Retention Requirements for
                                                        attendees will learn about the strategies for managing the DmP    EDC Studies
                                                        and re-application in your clinical Data management workplace.    Gaby Trespalacios, Vice President of Quality Systems and
                                                                                                                          Compliance, ClinPhone, plc
                                                        How to Create a Standardized and Hyperlinked DMP in one
                                                        Day                                                               MedDRA Coding Strategy for a Submission
                                                        Michael Goedde, CCDM, Director of Clinical Data Management,       Renee Cacchillo, Data Management Coordinator,
                                                        Human Genome Science                                              Eli Lilly and Company

                                                        Data Management Plan - A Road Map to Success
                                                        mary Baldovsky, associate Director, Data management,
                                                        Pharmanet, inc.




      1
                                             session DescriPtions anD Presenters




                                                                                                                                         Society for Clinical Data Management, Inc. - 2007 Fall Conference
WeDnesDay, sePtemBer 19, 2007
8:30 a.m. - 10:00 a.m.
Session VIIIA: Data Standards                                       Session VIIIB: CDM in Device Trials
session chair: Michelle Meany, Manager, Clinical Data               session chair: Vesna Zovkic, Manager of Hip Clinical
Management, Schering Plough Research Institute                      Research, DePuy Orthopaedics,
                                                                    a Johnson & Johnson Company
the use of standards is not something new; many of us have our
own standards. as the FDa moves toward the use of a platform-       exactly how different are device trials? this set of presentations
independent data standard for submissions – cDisc – we are all      will explore understanding the idiosyncracies of device trials
now faced with evaluating the impact this change will have on our   from a data management perspective. From overcoming the
current standards and processes. in this session we cover three     challenges in changing regulations to comprehending a different
data standards topics:                                              set of study objectives to simply learning a separate lexicon than
• an overview of cDisc and an update on the cDasH project           your pharmaceutical peers, this session is a “must-attend” for any
• Use of a cross-functional standards team                          clinical data manager already in or planning to enter the device
• Use of a common data elements (cDe) project                       arena.
                                                                    Data Management Challenges of Device Clinical Trials
CDASH: Building Global Consensus to Define CRF                      Reza Rostami, Manager, Clinical Data Operation,
Standards                                                           Duke Clinical Research Institute
Shannon Labout, CCDM, Senior Consultant, CSS Informatics
Rhonda Facile, CDASH Program Director, CDISC                        CDM in Device Trials
                                                                    Theresa Sampo, Founder and Principal Consultant,
Data Collection vs. Data Sharing: The National Institute of         Clinical Trial Data Services
Neurological Disorders and Stroke Common Data Elements
Project                                                             “Do you speak device?” A TMA perspective
Kristy Woolbert, Project Manager, Patti Shugarts, Operations        Patrick Stern, Manager, Data Management,
Manager, and Selma Kunitz, PhD, Principal, KAI Research, Inc.       Ethicon Endo-Surgery, Inc.

CRF/eCRF Standards - A Team Exercise
Cheryl Simon, Manager, GCDM and Carol Rybarczyk,
Supervisor, CRFD, Schering Plough Research Institute




                                                                                                                                           1
                                                        session DescriPtions anD Presenters
2007 Fall Conference Preliminary Registration Program



                                                        WeDnesDay, sePtemBer 19, 2007
                                                        10:30 a.m. - 12:00 P.m.
                                                        Session IXA: The Data Manager/Database Developer                    Session IXB: Data Quality Control and Audits in EDC
                                                        Relationship                                                        Studies
                                                        session chair: Pat Stetser, CCDM, Associate Director,               session chair: Susan Kozak, Associate Director, Wyeth
                                                        CDM, Accenture
                                                                                                                            in the ever-changing world of clinical data management, we are
                                                        Within the industry today, it is well known that a key factor to    constantly exploring new ways to improve our processes, work
                                                        ensuring that database development meets the needs of the           smarter, work faster and not adversely impact the quality of our
                                                        team is the relationship between the Data manager and the           data. With the change from a paper environment to electronic
                                                        Database Developer. this session will look at how these roles are   data capture systems; data managers, auditors, and inspectors
                                                        intertwined, how they have and are continuing to evolve and how     face new challenges to ensure not only the quality of subject
                                                        ensuring a strong relationship between these roles is necessary     data but also the integrity of the electronic data capture system.
                                                        for a success story.                                                this session’s focus will look at ensuring quality in the eDc
                                                        case studies will be used to show the good and the bad while        environment. this session will consider the following questions:
                                                        addressing the lessons learned. in addition, we will look at a      What is value added quality control in an eDc environment;
                                                        specific team who created a semi-automated system to support        how is an eDc system quality documented; how do we assure
                                                        discrepancy documentation creation that realized a 50%              preparedness for regulatory inspections.
                                                        time-savings during the time-critical start-up phase of study       Practical Implementation of EDC Study Audits
                                                        development.                                                        Jonathan Andrus, CCDM, VP, QA and Clinical Data Managemet,
                                                        Technical Advantages for Data Management/Database                   Phoenix Data Systems, Inc.
                                                        Development                                                         Electronic Data Capture Audits: What to Expect and How to
                                                        Domenica Romano, Manager, Clinical Data Management, Tech            Prepare
                                                        Ops., and Rinol Nol Alaj, Clinical Database Developer,              Crystal Leff, Audit Manager II, Wyeth
                                                        Schering Plough Research Institute
                                                                                                                            How Can You Trust the Data?
                                                        Walking the Walk, Talking the Talk: Relationships Between           Lisa Olson, Associate Director, Quality Assurance, i3
                                                        Data Managers and Data Programmers
                                                        Deborah Cole, CCDM, Clinical Data Specialist, Quintiles, Inc.
                                                        The Data Manager and Database Developer Relationship
                                                        – Building a Successful One
                                                        Raj Indupuri, Practice Manager, Eliassen Group




      0
                                                                          conFerence inFormation




                                                                                                                               Society for Clinical Data Management, Inc. - 2007 Fall Conference
Hotel anD location
all educational sessions, exhibits, registration, and social events held as part of the society for clinical Data management
Fall conference will take place at the following location:
Hyatt Regency Chicago
151 east Wacker Drive
chicago, il 60601
Web: chicagoregency.hyatt.com
Phone: (312) 565-1234
Fax:     (312) 239 4414

Just off michigan avenue in the heart of the magnificent mile, the Hyatt regency chicago hotel connects you to the best
music, art, entertainment and the nightlife of chicago. Hyatt regency chicago is recognized among chicago hotels for its
excellence in hospitality and cuisine, including stetson’s chop House and the Bar at 151. amenities include Wireless &
High-speed Dsl internet access, fitness center and spa.

room rates for 2007 are:
• $242 (single)             • $262 (Double)             • $282 (triple)             • $302 (Quad)

room reserVations
reservations will be accepted based upon availability. conference delegates are responsible for making their own
individual reservations. Please call (888) 421-1442 to make your reservation and identify yourself as being with the
society for clinical Data management. reservations may be made online via a link on the scDm website. reservations
need to be made by thursday, august 23, 2007 in order to qualify for the scDm group rate.

sPecial accessiBility neeDs
We encourage participation by all individuals. if you require special accommodations in order to fully participate at the
conference or if you have a special dietary request, please contact the scDm administrative office at (414) 226-0362. the
staff will be happy to assist you with your specific needs.

no smoKing
smoking is prohibited at all scDm meetings and educational sessions. guests of the hotel will be permitted to smoke in
designated smoking areas only.

conFerence attire
all sessions are business casual attire. Please remember that it is difficult to control temperatures in a hotel setting we
recommend that attendees bring along a light jacket or sweater to the session rooms. coat and tie are not required for any
of the evening social functions.

scDm JoB Postings
at the 13th annual Fall conference, there will be a forum for companies to promote open career opportunities to
conference attendees. if you have open positions, please bring multiple copies of your job posting to the conference.
similarly, if you are seeking a job, please bring multiple copies of your resume to post. all postings must be typed on 8.5”
by 11” paper. scDm will not take responsibility for resumes sent to the scDm office in response to a job posting. if you
would like more information about this service, please contact info@scdm.org.


                                                                                                                                 1
                                                        registration inFormation
2007 Fall Conference Preliminary Registration Program


                                                        conFerence registration Fees                                   registration QUestions
                                                        registration fees include access to the sunday opening         Please contact the scDm administrative office with
                                                        reception, continental Breakfast on monday and tuesday,        questions about registration for the scDm 2007 Fall
                                                        lunch on monday and tuesday, monday’s networking               conference.
                                                        reception, all educational sessions, access to the exhibit     telephone: (414) 226-0362
                                                        hall and the syllabus on cD-rom.                               e-mail: info@scdm.org
                                                        early registration Fees                                        cancellation Policy
                                                        (Postmarked on or before July 13, 2007)
                                                                                                                       if you need to cancel your registration for the 2007 Fall
                                                        scDm member: $650.00
                                                                                                                       conference you must submit your request in writing (post
                                                        non-member:      $700.00
                                                                                                                       or e-mail) prior to september 4, 2007. a $25.00 processing
                                                        regUlar registration Fees                                      fee will be charged for refunds. We regret that refunds
                                                        (Postmarked between July 14 – august 31, 2007)                 cannot be granted for requests postmarked or emailed after
                                                        scDm member: $700.00                                           september 4, 2007.
                                                        non-member:     $800.00
                                                                                                                       registration/inFormation DesK
                                                        late registration Fees
                                                                                                                       name badges and final programs will be distributed at the
                                                        (Postmarked after august 31, 2007)
                                                                                                                       registration desk located in the registration booth at the
                                                        scDm member: $750.00
                                                                                                                       bottom of the convention center escalators.
                                                        non-member:      $850.00
                                                                                                                       the registration desk will be open during the following
                                                        Pre-conFerence eVents:
                                                                                                                       hours:
                                                        saturday tutorial: introduction to coding: $495*
                                                                                                                       sunday, september 16                 7:00 a.m. – 8:00 p.m.
                                                        sunday tutorial: managing lab Data: $495*
                                                                                                                       monday, september 17                 7:00 a.m. – 7:00 p.m.
                                                        *Register for both: $900
                                                                                                                       tuesday, september 18                7:00 a.m. – 6:00 p.m.
                                                        leadership Forum: $250=
                                                                                                                       Wednesday, september 19              7:00 a.m. – 12:00 p.m.
                                                        register for both the leadership Forum and the Fall
                                                        =

                                                        conference and save $50.                                       HoW to register
                                                                                                                       to register, please return the form located in the back of
                                                        registration DiscoUnts                                         this program to the society for clinical Data management
                                                        if you register three or more people from the same             (scDm), 555 e. Wells st, ste 1100, milwaukee, Wi 53202
                                                        company you will receive a $25.00 discount on all              or fax to (414) 276-3349.
                                                        registrants.
                                                                                                                       attendees may also register online at www.scdm.org.
                                                        note: all registrations must be mailed together in order to
                                                        qualify for the $25.00 discount. this discount will apply to
                                                        scDm members as well as non-members. the discounted
                                                        rate only applies to the full-conference registration fee.
                                                        there is no discount for the Pre-conference tutorials.




      
                                                                                              sPecial eVents




                                                                                                                                  Society for Clinical Data Management, Inc. - 2007 Fall Conference
sUnDay, sePtemBer 16, 2007 – 6:30 P.m. – 8:00 P.m.              monDay, sePtemBer 17, 2007 – 5:30 P.m. – 7:00 P.m.
oPening recePtion                                               netWorKing recePtion
enjoy the tastes of chicago while you reunite with              on monday evening, please join us for a fun and relaxed time
colleagues and network with this year’s Fall conference         of networking with fellow colleagues and friends. cocktails
exhibitors and sponsors. all the exhibits will be located in    and hors d’oeuvres will be served in the Hard Drive lounge.
columbus Hall.

monDay, sePtemBer 17, 2007 – 12:00 P.m. – 1:00 P.m.
                                                                scDm “Data DriVen” innoVation
certiFication lUncHeon                                          aWarDs - neW
                                                                this year exhibiting and sponsoring companies are invited
                                                                to submit an abstract of a vendor/sponsor relationship
the certification luncheon will provide for an interactive      highlighting a new-technology product or service offering they
dialogue guided by certification committee co-chairs and        developed and deployed in production to innovatively address
members, beta testers and ccDms with in-house training          the sponsor’s study needs from a clinical data management
programs. learn about how they prepared for the exam,           perspective. the application deadline will be Friday, august
what advice they would have for those that are considering      11, 2007. the top five entries will be selected and information
taking the exam as well as for those that are “on the fence”,   about the competition and the finalists will be placed in each
and what the certification committee has planned for the        attendee’s conference bag. a panel of judges will review
upcoming year. you will not want to miss this discussion,       the finalists on sunday and monday. the winner and runner
even if you are already certified! Participants will be         up will be announced at the monday night reception. For
required to register in advance. space is limited to 100        more information and an application, on the “Data Driven”
registrants.                                                    innovation awards, please visit www.scdm.org.


2007 Fall conFerence sPonsors
(as of June 15, 2007)
golD sPonsor
sas (Box lunch on monday)
silVer select
clinPhone inc. (conference notebook)
i3 statprobe (certification luncheon)
mednet solutions (conference Bags)
nextrials, inc. (Hotel Keycards)
PPD (Water Bottles)
silVer
medidata solutions (conference signs)
omnicomm systems, inc. (lanyards)
Quintiles, inc. (Banners)
trialstat corporation (time Zone maps)
Patron
genentech, inc. (monday afternoon Break)
the cambridge group ltD (tuesday morning Break)
meDia
applied clinical trials
PharmaVoice                                                                                                                         
                                                        exHiBit Hall inFormation
2007 Fall Conference Preliminary Registration Program


                                                        exHiBit location anD HoUrs                                     2007 Fall conFerence exHiBitors
                                                        Please allow adequate time in your daily schedule to visit     (as of June 15, 2007)
                                                        the exhibit hall located in columbus Hall.                     accovion
                                                                                                                       applied clinical trials
                                                        exHiBit HoUrs                                                  ars, inc.
                                                        sunday, september 16                                           averion international corp.
                                                                                                                       the cambridge group ltd.
                                                        move-in                              12:00 p.m. – 5:00 p.m.    cDisc
                                                        sunday, september 16                                           clinForce, llc
                                                                                                                       clinPhone, inc.
                                                        opening reception exhibits open        6:30 p.m. – 8:00 p.m.
                                                                                                                       clintech research
                                                        monday, september 17                                           cmed research inc.
                                                                                                                       crF, inc.
                                                        exhibits open                        10:00 a.m. – 5:00 p.m.
                                                                                                                       css informatics
                                                        tuesday, september 18                                          DatatraK international
                                                        exhibits open                        10:00 a.m. – 3:30 p.m.    Drug information association (Dia)
                                                                                                                       Dsg
                                                        tuesday, september 18                                          DZs software solutions, inc.
                                                        move-out                             3:30 p.m. – 11:59 p.m.    eliassen group
                                                                                                                       eresearch technology
                                                        note: all exhibitors are welcome to attend the monday          etrials, inc.
                                                        networking reception.                                          Fast track systems
                                                                                                                       i3 statprobe
                                                                                                                       icon plc
                                                                                                                       imperial clinical research services, inc.
                                                                                                                       inc research
                                                                                                                       international Drug Development institute (iDDi)
                                                                                                                       Kendle
                                                                                                                       KForce clinical research staffing
                                                                                                                       Kika medical inc.
                                                                                                                       maJaro infosystems, inc.
                                                                                                                       medFocus llc
                                                                                                                       medidata solutions
                                                                                                                       mednet solutions
                                                                                                                       nextrials, inc.
                                                                                                                       omnicomm systems, inc.
                                                                                                                       Pharmanet
                                                                                                                       PharmaVoice
                                                                                                                       Phase Forward
                                                                                                                       Phoenix Data systems
                                                                                                                       Placemart Personnel service
                                                                                                                       PPD
                                                                                                                       PrometriKa llc
                                                                                                                       Quintiles, inc.
                                                                                                                       rPs, inc.
                                                                                                                       sas
                                                                                                                       smith Hanley
                                                                                                                       society for clinical Data management
                                                                                                                       strata
                                                                                                                       trialstat corporation
                                                                                                                       Uppsala monitoring centre
                                                                                                                       Westat
      
                                                                                         aDVertising oPPortUnities




                                                                                                                                                                      Society for Clinical Data Management, Inc. - 2007 Fall Conference
scDm annUal Fall conFerence Program
increase your exposure by advertising in scDm’s Final Fall Program. the program is a comprehensive guide to all
activities at the annual Fall conference and is distributed to all attendees.

scDm 2007 Fall conference exhibitors and sponsors can take advantage of a special offer of 10% off advertising in
scDm’s annual Fall conference Final Program.

Program aD rates (all aDs are grayscale/BlacK & WHite):
$1,500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 x 10”. . . . . . . . . . . . . full-page, non-bleed
$ 750 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 x 4 ¾” . . . . . . . . . . . ½ page horizontal, non-bleed
$ 750 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 ¼ x 10”. . . . . . . . . . . ½ page vertical, non-bleed
$ 500 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 ¼ x 4 ¾”. . . . . . . . . . ¼ page non-bleed

For more information, please contact meghan arnold at (414) 226-0362 or by e-mail at marnold@scdm.org. or reserve
your ad online at: www.scdm.org/events/Fall2007/advertise/

Data connections
Data connections is an electronic newsletter e-mailed monthly to all scDm members. the costs for electronic distribution
of an individual link to a web site, including a brief description of the company and services (six line maximum), as
advertisement to the membership via the scDm enewsletter are as follows:

aD rates
                                 x1                                       x2                                        x3                                      x4

                      $285 each                                $270 each                                 $255 each                               $240 each


     scDm also Has oPPortUnities to aDVertise emPloyment anD eVent Postings
                                        For more information, please go to www.scdm.org/employment




                                                                                                                                                                        
2007 Fall Conference Preliminary Registration Program



                                                        Dates to rememBer
                                                        July 13, 2007           early Bird conference registration Deadline

                                                        July 15, 2007           Final Payment due for Platinum, gold and silver sponsors

                                                        august 23, 2007         Hyatt regency chicago reservation cut-off

                                                        august 31, 2007         conference registration Deadline
                                                                                (late fees apply after this date)

                                                        september 4, 2007       cancellation Deadline

                                                        september 7, 2007       Pre-registration Deadline
                                                                                (register on-site after this date)

                                                        september 16-19, 2007   2007 scDm Fall conference




                                                                                                                       FUtUre Fall
                                                                                                                       conFerences
                                                                                                                       September 21-24, 2008
                                                                                                                       Hyatt regency Dallas
                                                                                                                       Dallas, tx

                                                                                                                       October 4-7, 2009
                                                                                                                       Westin seattle
                                                                                                                       seattle, Wa




      
Fall conFerence registration Form                                                                               For office Use only ________________




                                                                                                                                                        Society for Clinical Data Management, Inc. - 2007 Fall Conference
Please note: if you wish to qualify for the “three or more Discount” you may copy this form;
however each registrant must complete a separate application.                                                   member iD#   _________________

ParticiPant inFormation (this information will be used to create your name badge. Please type or print legibly.)
last name: ____________________________________________ First name: __________________________________________
title: ______________________________________________________________________________________________________
company or institution: _______________________________________________________________________________________
mailing address: ____________________________________________________________________________________________
city: _______________________________________ state:__________________Zip/Postal code: __________________________
telephone: (___) _________________________________________ Fax: (___) __________________________________________
e-mail address: _____________________________________________________________________________________________
Special Needs: Please indicate any dietary or accessibility needs:__________________________________________________
registration Fee inFormation
                                           (postmarked or                 (postmarked or                  (postmarked or                  Total:
                                         e-mailed by Jul. 13)          e-mailed after Jul. 13          e-mailed after Aug. 31)
                                                                     and on or before Aug. 31)
scDm member                                   $650.00                        $700.00                          $750.00                 $ ________
non-scDm member                               $700.00                        $800.00                          $850.00                 $ ________

If you are attending two days or less, please contact the SCDM office.
Pre-conFerence eVents
saturday tutorial: introduction to coding                                                                                               + $495.00*
sunday tutorial: managing lab Data                                                                                                      + $495.00*
*Both tutorials                                                                                                                          + $900.00
leadership Forum                                                                                                                         + $250.00
   i meet the requirements to participate (see p. 11)
sPecial sessions
certification luncheon                      yes                 no                                                                              $0.00
DiscoUnts
leadership Forum and Fall conference                                                                                                       - $ 50.00
three or more discount                                                                                                                     - $ 25.00
All three or more registrations must be submitted at the same time. (See p. 22)
total amoUnt DUe                                                                                                                      $ ________
Payment inFormation
Please make all checks payable to scDm (U.s. funds drawn on U.s. bank only) or provide credit card information. Please do not send cash.
   check enclosed                 Visa              mastercard              american express
credit card number _____________________________________________________ expiration Date: ______________________
                                                                                                                                 (month/year)
cardholder’s name __________________________________________________________________________________________
cardholder’s signature _______________________________________________________________________________________
register online at www.scdm.org or mail or Fax this registration form and fees to: scDm conference registration/555 e. Wells st./suite 1100/mil-
waukee, Wi 53202/Fax: (414) 276-3349. Questions?: contact Kim Breitbach or meghan arnold at (414) 226-0362 or e-mail: kbreitbach@scdm.org or
marnold@scdm.org.
cancellation Policy: if you need to cancel your registration you must submit your request in writing prior to tuesday, september 4, 2007. a $25.00
processing fee will be charged for refunds. We regret that refunds cannot be granted for requests postmarked after september 4.                           
                                    Prsrt stD
                                    U.s. Postage
                                        PaiD
                                    Hartland, Wi
                                    Permit no. 53



555 east Wells street, suite 1100
     milwaukee, Wi 53202

				
DOCUMENT INFO
Description: Clinical Datamanagement document sample