A monthly publication of the Society for Clinical Data Management.
Breaking News

 Have you considered the value of your SCDM membership lately?

Clinical data management professionals worldwide recognize the value of SCDM membership. Our membership continues to grow, both in North America and abroad. In 2009, we saw unprecedented renewal rates - a result of our efforts to provide career-long value to our members.

Your involvement in the Society becomes even more important in today's tight economy and competitive job market. Our member benefits provide you with access to industry-leading education and professional development opportunities, including the Annual Conference, our Good Clinical Data Management Practices resource, webinars and online courses - all designed to help you advance your career and provide more value to your employer.

The networking opportunities provided by SCDM are less tangible, but, for me, are among the most important reasons to continue my membership. I meet new contacts and reconnect with friends at SCDM conferences and have made life-long friendships through my committee and Board involvement. It is so valuable, on both personal and professional levels, to be part of this dynamic, international group of my peers. If you're not already engaged as a GCDMP subject matter expert, on an SCDM taskforce or in another position, I encourage you to consider volunteering - it's the best way to get the most from your membership.

On behalf of the SCDM Board, we hope you'll continue to join with us as we work to advance the profession of clinical data management. Through our efforts, including our Certified Clinical Data Manager (CCDM®) program and other professional development offerings, clinical data managers are increasingly recognized as a vital part of the clinical research process. But there's still more work to do.

Thank you for being a member. We hope you'll consider renewing your membership now.

Please remember that your SCDM leadership is committed to the continued improvement of your Society. If you have suggestions for ways to increase the value of your membership, please let us know at info@scdm.org.

Susan K Howard
2010 Secretary
SCDM Board of Trustees


 Celebrate Your Company's Commitment to Certification with the 2010 CCDM® Industry Partner Program

CCDM® Industry Partner Program

SCDM wants to recognize companies that have made a commitment to quality clinical data management. Our revised CCDM® Industry Partner Program recognizes companies that meet at least one of the following criteria:

Qualifying companies can display the CCDM® Industry Partner Program logo on their Web site, recruitment materials and marketing materials, and will be recognized by SCDM throughout the year online, in print and at events.

Certified Clinical Data Managers have met requirements of education and experience and have passed an exam testing key competency areas in CDM. CCDM credentials must be maintained by fulfilling renewal requirements every three years.

For complete program details and an application, visit www.scdm.org/certification/industry-partners.


 Apply for the CCDM exam by Dec. 31 to lock in 2009 rates

Certification through SCDM identifies versatile, capable professionals with expertise in all functions of clinical data management.

Apply for the Certified Clinical Data Manager (CCDM®) exam by December 31 to guarantee the 2009 rate. You'll still have up to 90 days to schedule your exam.

As an added bonus, we'll also give you 50% off select SCDM On-Demand Webinars to help you prepare for the exam.

Purchase one or all. Your choice of:

SCDM On-Demand Webinars are a convenient way to learn the CDM core competencies addressed in the certification exam. On-Demand Webinars can be accessed at any time, from any computer with an Internet connection, and can be viewed as many times as needed within 90 days.

For more information about the Certified Clinical Data Manager program, eligibility and topics tested, click here.

Apply now!

Upon registering for the CCDM exam, a webinar coupon code will be sent via e-mail. To receive the discounted price, On-Demand Webinars must be purchased by December 31.

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Educational Opportunities

2010 Professional Development Calendar
2010 Online Course Offerings
Program Begins
Data Management Plans Online Course January 17, 2010
CRF Design Online Course March 28, 2010
Query Processing and Tracking/Database Updates Online Course May 9, 2010
Metrics and Identifying Data Trends Online Course June 13, 2010
SAE Reconciliation, Safety Review and Coding Online Course July 25, 2010
Managing Lab Data Online Course September 5, 2010
Database Lock and Randomization Online Course October 10, 2010
Project Management for the Clinical Data Manager Online Course November 7, 2010
2010 Webinar Schedule
Database Updates Webinar January 28, 2010
Lab Data Webinar February 25, 2010
CDISC Webinar March 18, 2010
Data Management Plans Webinar April 22, 2010
Managing Virtual Teams Webinar May 20, 2010
Overall Clinical Trials Process, Roles and Responsibilities Webinar June 17, 2010
Touch Point/Hand offs (with SAE Reconciliation) Webinar September 16, 2010
Protocol Review Webinar November 18, 2010

 On Demand Webinars

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

 New GCDMP Podcasts Available

Don't have time to read the GCDMP? We have your solution! Download the GCDMP chapter podcasts. Podcast recordings of the new Laboratory Data Handling and revised Data Entry Processes chapters can be downloaded to your MP3 player now.

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Get Involved

 Item / Question Writers Wanted

WANTED! - SCDM Item Writers, Volunteers to Contribute to the Future of the CCDM Certification:

SCDM is looking for 20 Subject Matter Experts (SME's) to write questions for the next version of the Certification Test, and to support ongoing educational opportunities by writing questions for Practice Exams and online courses hosted by SCDM.

Requirements for SME's include:

  • Three to five years of direct experience with the topic at an expert level
  • Good communication skills and a good command of the English language
  • Ready access to necessary authorities or resources to confirm accuracy or compliance of content according to governmental or regulatory agencies or other authoritative bodies and guidances
  • Must have the available time needed to serve in the capacity of SME, estimated to be approximately 40 hours over the course of the assignment
  • A collaborative attitude and a commitment to contribute to the development of the CDM profession

Work on the next version of the Certification Test will begin in the first quarter of 2010 and continue until the test is ready for roll-out in 2011. Item writing for online courses will be an ongoing activity. Appropriate training and access to reference materials will be provided.

If you are interested in becoming an Item Writer for any one of these activities, please prepare a half page statement of interest in which you will describe the GCDMP chapter(s) or topics in which you are qualified, and your experience that qualifies you as a Subject Matter Expert. Send your statement of interest and your CV to Sharon Kayne Chaplock via e-mail schaplock@scdm.org

 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: Protocol Review and Safety Data Management and Reporting.

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.

If 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 Sharon Kayne Chaplock at schaplock@scdm.org.

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News Updates

 Get to Know the CCDM®

SCDM is proud to introduce Maron Azar, CCDM, as a recipient of the Certified Clinical Data Manager designation. Maron is an Assistant Clinical Data Manager with Quintiles International in Bloemfontein, South Africa.


Q: Why did you become certified?
A: The benefits of being part of a 'structure/body' that ensures proper knowledge transfers and updates regarding our line of business and expertise.

Q: What challenges did you have taking and studying for the exam?
A: The challenge for me was in planning for enough time to actually prepare for the exam and executing that plan in-between my 'day job' and family responsibilities. The exam itself was very challenging due to large variety of questions, amount of questions and close proximity of correctness regarding possible answers for each scenario.

Q: How has being certified benefited you?
A: I was certified only this year and am still getting accustomed to having the 'SCDM Toolbox at my disposal. Thus far - I have enjoyed the webinars and the possibility of presenting at these webinars. I value the spectrum of experience and knowledge that is shared at the webinars - it makes our world of Data Management an almost 'touchable entity'.

Q: What materials did you use to study for the exam?
A: GCDMP

Q: Can you provide helpful hints for those interested in taking the certification exam?
A:
  • Plan, plan, plan!
  • Execute your plan in preparing for the exam.
  • Do a thorough/comprehensive review of the GCDMP
  • Remember - you know more than you think! Trust your DM experience.




 SCDM welcomed these NEW members in October 2009!

Nitesh Bandekar
Celeste Crouse
Mirella Di Stasio
John Finn
Mike Harbaugh
Laurie Hofer
Christine Lys
Michelle McClanahan-Crowder
Michael McDevitt
Cindy McLaughlin
Jessi L. Odle
Anita Palmer, MS
James Rogers
Roberta Rosenberg, MS
Leigh Ann Sochacki
Soni Suchitra
Chris Wilke

 Companies Demonstrate Commitment to Certification

The CCDM® Industry Rewards Program is now closed for 2009. Watch for updates this fall on the 2010 program.

SCDM rewards the following companies for their commitment to excellence through their support of the CCDM® program:

Industry Master — 100% of CDMs are CCDM®s

Industry Champion — 50% of CDMs are CCDM®s

Industry Leader — 25% of CDMs are CCDM®s

Partner Level — 10% of CDMs are CCDM®s

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Upcoming Events

ExL Pharma's Multiple Comparisons in Clinical Trials
January 25-27
Washington, DC

Clinical trials give rise to enormous amounts of data, both on efficacy and safety. The findings from these trials should be treated with caution and application of statistical methodologies should be defined upfront. The focus of this meeting is to describe and discuss recent developments of methods for handling multiple comparisons, with specific applications in clinical trials. Areas covered include:

  • Multiple dose comparisons
  • Comparisons with a control
  • Multiple endpoint comparisons
  • Interim analyses
  • Multiple subset comparisons.

Expert biostatisticians from industry, academia and regulatory agencies will review and recommend methods, demonstrated with case studies.

For more information or to register, please visit: www.exlpharma.com/multiplecomparisons

ExL Pharma's Site Selection, Activation and Communication
February 1-2
Washington, DC

The selection and evaluation of clinical sites and investigators is critical for the successful completion of clinical trials within budget and timelines. The site selection process and the sponsor-site-investigator relationship are key areas of opportunity in accelerating the drug development process while generating high quality data.

While most conferences remain focused on only one or two aspects of sponsor and site relationships, this conference takes an in-depth look at specific steps and a critical analysis of existing practices, challenges and opportunity to formulate a more solid partnership between sponsors, sites and investigators.

For more information or to register, please visit www.exlpharma.com/siteselection.

VIBpharma's Evolution of Data Management in Clinical Trials USA
February 23-24
Washington, DC

This conference will deliver practical ideas and solutions to help manufacturers and CRO's improve their data management processes, increase efficiency and speed time to market.

With the global emphasis on cost-saving in 2009, improved data management strategies can deliver the long-term cost reductions necessary to survive the current downturn and ensure long-term success. Through a series of presentations and discussion from leading manufacturers, this conference will deliver time and cost saving ideas that you can easily incorporate into your data management program.

To register, visit www.arena-international.com/pharma/datamanagementusa/register.asp; receive a 10% discount on the registration when you reference code SCDM.

For more information please e-mail melissafuentes@arena-international.com.

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