IMPORTANT ANNOUNCEMENTS

Reminder: Vote Now for SCDM Bylaws Amendments

Only a few days remain to cast your vote for proposed SCDM Bylaws changes.

All SCDM members are eligible to vote. If you haven't voted yet, follow the link below or visit the Members Only section of the SCDM Web site.

Vote Now!

Votes must be received by March 4.

You will need your SCDM member login information to access the ballot. If you need your login information or have additional questions, please contact info@scdm.org.

Only a Few Spots Remain for the SCDM Leadership Forum

2009 SCDM Leadership Forum
March 15-17
Vanderbilt University
Nashville, TN

If you've been waiting to register for the 2009 SCDM Leadership Forum, don't delay any longer.

Registration for the SCDM Leadership Forum is nearly full. We expect these last remaining spots to fill quickly.

Reserve your space today.

With a theme of "Strategic Leadership in a Changing Environment," the 2009 SCDM Leadership Forum is a unique opportunity for executives in clinical data management to join other leaders in strategic discussions of key industry issues.

We have several exciting speakers lined up to address this topic. Highlights include:

• Keynote speaker Congressman Jim Cooper (D-TN), an instructor of health policy at Vanderbilt University and a healthcare policy adviser to the Obama presidential campaign, offers an insider's look at healthcare policy trends and challenges
• Tom Moreno, U.S. Food and Drug Administration, heads a discussion on developing and applying risk management methods
• Katherine Vandebelt, director of Data Sciences and Solutions (world wide) at Eli Lilly and Company, and Joseph Anderson, principal associate at Waife and Associates, will discuss effective leadership in the changing environment of clinical data management.

The SCDM Leadership Forum specifically targets executives and other decision-makers in clinical data management. Don't miss this opportunity to learn from and network with industry leaders in a personal environment.

Register Now

Complete Leadership Forum details, including a schedule of events, are available online.

SCDM would like to thank the following 2009 Leadership Forum Sponsors:

Monday Luncheon Monday Reception Monday Continental Breakfast Tuesday Continental Breakfast

Monday Morning Break Tuesday Morning Break Audience Response System

SCDM Hopes to See You at DIA Data Conference

The Society for Clinical Data Management will be attending the Drug Information Association Data Conference and Exhibition, March 9-11 in Philadelphia.

Visit SCDM (booth 304) in the exhibit hall to learn about volunteer opportunities within SCDM or share your suggestions for educational and professional development programs that would enhance your SCDM membership.

You can also bring a colleague who you think could benefit from SCDM membership or our Certified Clinical Data Manager (CCDM®) program.

SCDM Education Director Sharon Kayne Chaplock will be available to take suggestions, answer questions and promote the value of SCDM membership and programs.

The DIA Data Conference is a multi-track conference to discuss standards, processes, and infrastructure across the clinical data lifecycle. If you are interested in attending, register online now.

To learn more about SCDM programs or submit feedback, please contact SCDM at 414.226.0362 or info@scdm.org. For additional conference details, visit the DIA Web site.

New GCDMP Podcasts

Podcast recordings of new and revised GCDMP chapters can be downloaded to your MP3 players now. Just go to GCDMP page on the SCDM Web site to access these new additions:

• EDC Study Startup
• EDC Study Conduct
• EDC Study Closeout
• Data Management Plans
• Measuring Data Quality

EDUCATIONAL OPPORTUNITIES

Don't Miss: Archived Webinar Addresses Trend Toward EHR, EDC

Trends toward electronic health records and other healthcare technology will affect nearly every aspect of clinical trials, including how clinical data managers receive and interpret data in the future.

With this shift in mind, SCDM recently hosted a webinar "Trends Shaping Clinical Data Management" to address expected changes and challenges to the industry.

President Obama has put an emphasis on expanding use of electronic health records and improving health technology, including a $19 billion commitment in the recent economic stimulus package, making this topic timelier than ever.

"I think it's an incredibly auspicious moment to be talking about the electronic health record in the context of the clinical trial because the EHR … is really ready to play a significant role in clinical research," said Mark Uehling, editor of Clinpage and an expert presenter for the SCDM webinar. "(The stimulus package is the beginning of) a significant federal push that we are going to see to help people train and learn how to use these technologies and develop them and integrate them."

The webinar also featured insights from Steven P. Schwartz, senior vice president of corporate business development at Allscripts, and Anthony Costello, a former chair of the Society for Clinical Data Management.

Learn more: The complete two-part webinar, including the question-and-answer session, is now available for purchase online. SCDM is authorized by IACET to offer .2 CEU credits for this program.

SCDM has eight webinar series remaining in 2009 on topics including:

• Data management and oncology trials
• Emerging and established standards
• Database validation and surviving an audit

A complete schedule of upcoming webinars is available online.

Enjoy Reading Data Basics? Now is Your Chance to Contribute to the Next Issue!

This is a wonderful opportunity to earn SCDM participation credits toward certification renewal.

Please contact Sue Abrahms at sabrahms@scdm.org for submission requirements.

Now Accepting Abstracts for Annual Conference

2009 Annual Conference
October 4-7
Westin Seattle
Seattle, WA

The 2009 Annual Conference Call for Abstracts is NOW AVAILABLE ONLINE!

The Annual Conference Taskforce is soliciting abstracts for possible presentations for the 2009 Annual Conference. Please submit abstracts on topics that match your interest and expertise.

A complete listing of suggested topics, including information on how to submit an abstract is available online.

For additional information, please contact SCDM at 414.226.0362 or info@scdm.org

Professional Development Opportunities 2009 Webinar Schedule

For more information and registration, please click on the webinar title below.

To sponsor a webinar, please CLICK HERE.

SCDM CLASSIFIEDS

SCDM Travelport Offers Convenient, Personalized Travel Service

As a special program for our members, SCDM has partnered with Olson Travel in Milwaukee to offer the SCDM Travelport - a one-stop online source for making flight, vehicle and hotel reservations.

Next time you are in need of travel arrangements, visit the SCDM Travelport, located in the events section of the SCDM Web site.

The Travelport can be used to book travel arrangements for SCDM-related travel or other business or personal use. Once you have made a reservation, you will be able to view your itinerary online, print/e-mail your schedule and view destination details, including hotel photos and area events.

You can also set a personal profile - with saved seating and hotel preferences and frequent flier programs - for quick service and personalized recommendations.

SME's Wanted

WANTED! Short-Term SCDM-GCDMP Volunteers:
Subject Matter Experts 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: Data Acquisition, Edit Check Design Principles; Project Management for the Data Manager; Database Closure; Metrics for Clinical Trials; Systems Validation/Systems Auditing; External Data Transfers.

There is an immediate need for Data Acquisition, Edit Check Design Principles and Project Mangement for the Data Manager.

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 30 to 40 hours over the course of the assignment

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.

Volunteer Speakers Bureau Forming

Share your knowledge of best practices.

Let us know your group is meeting.

SCDM is organizing a Volunteer Speakers Bureau composed of experts in topics of interest to clinical data managers. If you have experience and expertise in areas that are aligned with the GCDMP and have strong presentation skills, SCDM invites you to join!

Volunteers may be called upon to be presenters for webinars, conferences or other venues. If you are interested, please send your CV and a history of your presentations to info@scdm.org.

Content Specialists Needed for Project Management and Data Management Online Courses

SCDM is working in partnership with Leadership Online to create online courses for clinical data managers seeking to advance their knowledge of the discipline or attain the CCDM® credential. The SCDM Board of Trustees has identified the development of these programs as a major goal among its strategic priorities for 2009-2012.

The Board has engaged the services of Leadership Online to meet the objectives of developing an educational track focused on CDM technical skills and on CDM project management skills. Leadership Online is a Wisconsin-based company that has developed over 3,000 hours of web-based learning applications for such organizations as the Medical College of Wisconsin, Marquette University, the Associate Degree Program in Medical Coding at Madison Area Technical College, GE Medical and Sedation Management at Centegra Health Systems.

Content experts should have the following qualifications:

• 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
• Experience with online pedagogy and learning
• Must have the available time needed to serve, estimated to be approximately 30 to 40 hours over the course of the assignment

Work is in progress now and will continue until the courses are complete - approximately two to three months.

If you are interested in becoming a Content Specialist for any one of these courses please send your qualifications, CV and the course(s) you are interested in to Sharon Kayne Chaplock at schaplock@scdm.org

Have you Formed a Study Group to Prepare for the CCDM® Exam?

SCDM is looking for CDMs who have formed or participated in a study group that helped them prepare to sit for the Certified Clinical Data Manager exam. The Society is assembling a group of volunteers to contribute to a best practices page of the Education Portal that will serve as a guide for forming effective study groups. This is a short-term project that will contribute to the content of the webpage on what works in terms of structure, content, frequency and support materials. Your experience is vital to the successful launch of this resource.

As part of this initiative, SCDM will be posting locations that are hosting study groups. If you have a study group planned or that is meeting now and would welcome people to join, please let us know so that we can post it on the Web site.

To respond, please contact Sharon Kayne Chaplock at schaplock@scdm.org. The group will meet via teleconference as soon as the group is formed.

IN OTHER NEWS

Get to Know the CCDM®

SCDM is proud to introduce Marsha Charron as a recent recipient of the Certified Clinical Data Manager (CCDM®) designation. Marsha is a senior clinical data manager with Kendle in Waterford, CT.

Q: Why did you become certified?
A: Data management is an area with defined processes but it also involves abstract thinking and decision-making. Certification confirms that my data management experience can be quantified, measured and validated–just like data management itself.

Q: What challenges did you have taking and studying for the exam?
A: The biggest challenge was finding the time to study. Juggling life and work time is always a balancing act. This exam is known to be tough but knowing that ahead of time helped me to stay more focused during my study sessions.

Q: How has being certified benefited you?
A: It is still a bit early to really know the benefits; however, the most immediate one is the self respect I feel at having done well on the exam to become certified.

Q: What materials did you use to study for the exam?
A: The Good Clinical Data Management Practices document formed the basis of my study material. The most effective study tool, though, proved to be my experience in data management.

Q: Can you provide helpful hints for those interested in taking the certification exam?
A: Studying in a group is ideal, but if that is not possible, self study is still very effective. Set aside defined study time and keep the sessions short, half-hour increments work well. Read through a chapter to see what is being reviewed then go back and review section by section. Ask yourself if there is anything that is unclear and try to find resources to help clarify.

Q: Any additional comments you would like to provide?
A: It was definitely worth the study time and effort to become certified. The accomplishment is the best reward.

SCDM Welcomed the Following NEW Members in January:

SCDM Congratulates Members Entering their Fifth Year of Membership in January:

SCDM Congratulates Members Entering their 10th Year of Membership in January: