A monthly publication of the Society for Clinical Data Management.
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SCDM Webinar

 Managing Virtual Teams Webinar

April 22 - 11am CDT 60-minute presentation followed by 30-minute Q&A

Presenters
Donna Gugger, associate director, clinical data management at United BioSource Corporation (UBC). Donna has worked at UBC for the last six years and has a total of 21 years of Data Management experience, including various therapeutic areas in Phase I, II and III studies.

Lisa Hanson, project manager at United BioSource Corporation (UBC). Lisa has 18 years experience in drug development with a focus on data management, electronic data delivery, project management and clinical trial execution.

Overview

This program will emphasize strategies for ensuring that virtual teams within a clinical data management environment function well, accounting for challenges that include resource management, training, cultural and language differences, building trust, multiple time zones, goal setting, accountability and team cohesiveness. Case studies will be referenced to illustrate effective practices as well as how challenges were met.

IACET

Continuing Education Credit Opportunity
Attendees are eligible for CEUs upon attendance and successful completion of assessment question.
For further information and to register please click here.

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 SCDM 2010 Annual Conference

Is your company looking for ways to gain exposure?

Become a 2010 Annual Conference exhibitor or sponsor. Packages available to fit all marketing budgets and guaranteed to increase your potential client base. Exhibit booths at the conference begin at $2,800. For even more exposure, SCDM has sponsorship packages available beginning as low as $2,000.

The exhibit hall is open for three days - Sunday, Monday and Tuesday. All meal functions during hall hours are held within the hall, including Sunday night's networking reception.


Increase your company's exposure by submitting an entry for the 2010 Data Driven Innovation Award. All exhibiting or sponsoring companies are invited to submit a product or service developed to benefit the discipline of CDM. For more information, guidelines and an application, click here.

Click here for applications and further information on the 2010 Annual Conference exhibiting and sponsoring opportunities.

Questions? Contact Jean Wenzel at 414.226.0362 or jwenzel@scdm.org.

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Educational Opportunities

 Query Processing & Tracking and Database Updates Online Course

May 9 - May 29

The vast majority of the clinical data manager's time is spent in data clarification, verification and validation. This foundational course will focus on these processes, and contribute to the data manager's ability to identify discrepant data and effectively address data clarification needs. Knowledge from this course can be applied to EDC or paper processes.

Click here for additional information and to register.

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New GCDMP Podcasts Available

Don't have time to read the GCDMP? We have your solution! Download the GCDMP chapter podcasts. Download the podcast recording of the new Edit Check Design Principles chapter to your computer or MP3 player today.

On Demand Webinars

SCDM On Demand Webinars offer the convenience of viewing and listening to recordings of live events on your schedule. Click here for the most recent webinar recordings available.


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Get Involved


 Call for Online Course Content Developers

Do you love to teach? Have you been told you're a natural born educator? Is training part of your job? Do you have areas of CDM expertise? Would you like to give back to the CDM profession?

If you answered "yes" to any of these questions, we invite you to join the following Content Development Teams for new SCDM online courses. Active development time when most meetings will occur is included beside each course.

SAE Reconciliation Safety Review & Coding April 12 - June 14
Managing Lab Data July 7 - August 30
Database Lock & Randomization August 30 - October 1

Work includes drafting a course outline, identifying content resources, creating slide decks, drafting discussion questions and creating assessment items. You'll be guided by an experienced instructional designer. As an added benefit, you'll learn about the process of creating online courses and even be rewarded with participation credits that count toward renewal of your CCDM® credential.

To apply, please send the following to schaplock@scdm.org:

  • A short paragraph outlining why you want to join the team
  • Explanation of your qualifications
  • The course you'd like to work on
  • A copy of your resume or CV

 SME's Wanted

WANTED! Short-Term SCDM-GCDMP Volunteers:
Subject Matter Experts needed to review the next Good Clinical Data Management Practices (GCDMP) chapters scheduled for revision.

SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Safety Data Management and Reporting, Data Integration, Preparing For and Surviving an Audit, Data Storage and Detecting Fraud.

Requirements for SME's include:

Work will begin as soon as SME's are identified and continue until chapters are complete - approximately two to three months.

SMEs are eligible to receive participation credits, which can be used toward certification renewal.

IIf you are interested in becoming a Subject Matter Expert for any of these chapters, please send your qualifications, CV and the chapter(s) you are interested in to Amanda Knack at aknack@scdm.org.

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News Updates

 BoT Update®

The Board of Trustees met in San Antonio, Texas, on March 14 and 15 for our quarterly meeting.

A discussion of trends in the industry was one of our first topics. There have been numerous mergers and acquisitions in the industry and our Board members are not immune to these changes. It is now more important than ever to show the value of data management and the value of our certification program. We continue to look at strategic partnerships for our organization so that we can strengthen what we have to offer our members and stay ahead of industry trends.

Metrics are important to us in our Board roles as well as in our regular work life. We discussed additional reports we would like to review on a quarterly basis to gauge our performance over the last several years. As with any discussion of metrics, it is important to not get carried away with data overload and ensure measurement of key indicators.

We reviewed how we are doing as a Board. Vice Chair Nimita Limaye recently attended a Board Leadership conference with our executive director, Eloiza Altoro-Acevedo, and shared information from that conference, allowing us to consider how we evaluate our roles as Board members and as a complete Board. It is important to ensure we are a group where free exchange of ideas occurs and where we challenge the status quo to ensure we are doing the best possible job for the organization. We will be doing some additional strategy building around Board Governance in the future. It is a different level of responsibility to oversee the direction of an association. Eloiza ensures we have the information we need to do the job right.

We also heard some of the work in progress for the Board of Trustees meeting in Minneapolis in October. The Annual Conference Taskforce is doing a great job planning yet another exciting conference. For those of you who have not been involved in the Annual Conference Taskforce, this is not an easy job - but it can be very rewarding!

Finally, the Board also met with the Committee Chairs. This outstanding group has been busy writing product road maps. We look forward to the building of new products, strategy and the continued implementation of the committee plans.

Susan K. Howard
Secretary
SCDM Board of Trustees

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Dr. Abhishek Kadam, BHMS, CCDM

 Get to Know the CCDM®

SCDM is proud to introduce Dr. Abhishek Kadam, BHMS, CCDM, as a recipient of the Certified Clinical Data Manager designation. Dr. Kadam is an associate data analyst with Cognizant Technology Solutions India Pvt. Ltd in Mumbai, Maharashtra.

Q: Why did you become certified?
A: For me, becoming certified meant learning the latest CDM best practices. The certification also helps me grow as a CDM professional.

Q: What challenges did you have taking and studying for the exam?
A: The challenges were many. Taking time off for studies from a tight schedule was the most challenging task. I was supported by my organization. Once time was made available, utilizing it for studying was not a big challenge.

For the exam the challenge was to get acquainted with the nature of exam. For this I became a member of SCDM, used the self assessment tool and the GCDMP. Thank you to the SCDM staff as well for getting the logins and password in time.

Q: How has being certified benefited you?
A: Getting certified has definitely brought recognition in the organization.

Q: What materials did you use to study for the exam?
A: I used The GCDMP and Practical Guide to Clinical Data Management 2nd Edition.

Q: Can you provide helpful hints for those interested in taking the certification exam?
A:
  1. Get to know the competencies for which one would be tested
  2. Make use of the Self assessment tool
  3. View the CCDM exam Prep Strategies archived webinar
  4. Study the GCDMP for what are the minimum standards and the best practices
  5. Study in a group
  6. Discuss the chapters and the finer points
  7. Most importantly trust your experience while answering the questions


Looking for a step up in your career?
Why not become a Certified Clinical Data Manager?
For more information visit www.scdm.org/certification


Submit your News
Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to Sue Abrahms at sabrahms@scdm.org.
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 SCDM welcomed these NEW members in February 2010!

Tiffany Alderson
Deborah E. Alexis-francis, BS
Deven K. Babre, CCDM
Matt Baker
Patricia Bartlett, BS
Frank Beddia, BSc
Kendal Benza
Navindra Boodhoo
Charles Bunn
Danielle Caswell
Ning Cegielski
Stephannie Charles
Jean Cheng, BA
Salvador Corona
Trisha A. Crawford, Sr.
Laura D'Angelo Day
Cora Dela Cruz
Wayne DellaMaestra, BS, MCS
Kellie Duncan
Charlotte G. Eddins, RN
Winni Fad
Maria Fassano
Tina France
Carol Frazee
Sharon Frost, MS
Michelle Galindo
Richard Gee
Krishna Ghoshal, MCA
Theodore Gillan, CCDM
Krishnan S. Gopal, PhD
Angela Hall
Rashmi S. Hardikar, BS
Shawn Harrison
Kelly Haupert, BS
Jennifer Hawkins
Susan Heard, BS
Heather Heimerdinger
Demetric L. Hillman
Kayo Inushima
Kazumasa Iwamoto, BS
Melissa Johnson
Sharon Jung, BCompSC
Bridget-Anne Kirwan, PhD
Sonali Krishnan, CCDM
Sandeep Kumar, MCA MBA
Valdelania Aparecida Lamounier, RN
Tracie Lomax, BS, MS
Tomoko Maegawa
Megan DeLuca Malloy
Victor Marciano
Dmitri Mariassov
Winifred A. Meeker-O'Connell
Beverly A. Mersing
Annamaria Muraro, BSc
Tamara D. Nickerson
Frances Nolan
Maricia B. O'Connor, II, MS
Kristal Pennington, MBA
Alecia Peterson
Rita Philavanh
Andrew Pikus, BS
Nick Pokoluk, BS
Susan Rapp
Chris Reid
Tanya Santelli
Jhansi Lakshmi Saranu, BDS PGDCR
Michael Sieb, Dipl HTL Ing
Diane L. Siegel, CCDM
Laura Smith
Anamika Takle
James H. Tatsch
Mary Templeton, BS
Mary Tipmore
Janice Pui-Yin Tseung, BSc
Lynn Van Dermark
Lisa Wandersee-Gleason
John Werner, BA PMP
Marsha Williams
Jennifer Williamson
Bret Wilson
Steve Wong
Zhongqi Xu
Vicken Yanikian, BS
Angelica Yesepkin
LeighAnn Zimmer-Abel

 SCDM congratulates the following members for entering their 5th year of membership in February 2010!

Linda Allen, BS
Bernadette Brown
Natalie Carnahan, BS
Angela Di Donato, BA
Jennifer Egizio
Larry Emerson
Heather A. Gerding, CCDM
Vikas Gulati, CCDM
Hiromi Hasegawa, BSN
Diahann Higgins, BA
Hiroshi Honkawa, BS
Julie Ju-Yeon Kang, BS
Elizabeth Keller
Susan Keller
David Kozlowski, BS
May Luo, CCDM
Karine Ly
Molly Magee
M. Joseph Mardesich
Kimberly Marty, BSc
Sherrie McCaskill
Elzbieta McElroy
Yttel Mercedes Mora, RN, BSN
Melissa Philbrook
Rachel Rerko
Lynda R. Sawyer
Aldo Schepers, PhD
Cheryl A. Simon, CCDM
Susan M. Smith
Karen Spohn
Dorothy L. Stokes, CCDM
Daniel R. Stover, MT (ASCP), CCDM
Brooke Trupin
Katherine Vandebelt
Maria Villarroel
Suzie Young
Linda Zheng, MS

 SCDM congratulates the following members for entering their 10th year of membership in February 2010!

Karen E. Green
Leon Hoffman
Alicia Mae Noel, CCDM
Nancy A. Sigman
Lori Tholkes Venable, BS

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Special rates for AHIMA ICD-10 Summit

2010 ICD-10 Summit
A Strategic Approach to Challenges and Opportunities
Washington, DC
April 12-13

The Second Annual ICD-10 Summit builds on the progress of last year's summit, and further explores challenges of the transition to ICD-10-CM/PCS. Leaders from every segment of the healthcare industry will collaborate and exchange information to strengthen the industry.

Get ready to experience an atmosphere of openness and discovery, inspiring you on your journey. Discover how a carefully planned process can yield a smooth, successful transition, taking you beyond simple compliance and on to strategic advantage. Come ready to share your ideas. Leave with valuable information, resources and connections!

Pricing

  • Collaborating Partner Price (without audio recording) $699
  • Collaborating Partner Price (with audio recording) $849*

*Audio recordings will be provided within eight weeks after the Summit.

Take advantage of special pricing available only to collaborating organizations by entering Coupon Code MX4376 when registering for the event. Discounts will be reflected at check out.

Visit SCDM at IIR eClinical Technology Summit

The Society for Clinical Data Management is proud to be a media partner at the 14th Annual eClinical Technology Summit, April 12-14 in Orlando, FL. Visit us in booth #142.

Register for this event to:

  • Explore all-new methods for integrating eclinical systems to improve data quality and drive efficiency
  • Learn how the shift from the "blockbuster" drug to the "nichebuster" can contribute to pipeline growth and increased revenue.
  • Network with 2,000 clinical professionals from the co-located Partnerships in Clinical Trials event
  • Master FDA guidelines and standardization initiatives to speed time to market
  • Get up to date on site preferences to save time and money on your clinical trials
  • Leverage the new patient-centered clinical trial model with telemedicine and health information technology
  • Determine how to integrate and connect electronic health records with your existing systems to boost patient and physician recruitment

Please use Priority Code XP1509SCDM when registering.

For full program details and the complete speaker faculty line-up, download the conference brochure.

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