We hope you like our new look!
Data Connections has undergone a transformation to make it more reader-friendly.
One thing hasn't changed: Each month, you'll still find all the important announcements and information that you expect.
You will see other changes over the coming months as we continue our improvements.
As always, we welcome you feedback at info@scdm.org.
Membership Ratifies Bylaws Revisions
The SCDM membership ratified the recently proposed Bylaws amendments, making clarifications and minor changes to membership eligibility, leadership offices and committee structure, among others.
To read the updated Bylaws, click here.
Leadership Forum Provides Strategies for Changing Times
We welcome your feedback on this year's Leadership Forum. You should have already received an e-mail survey invitation. Please help us to continue to meet your needs by completing this short survey. If you did not receive the e-mail, or have additional comments, please contact Margaret Trotter, SCDM meetings manager, at mtrotter@scdm.org.
Again in 2009, the SCDM Leadership Forum provided an unmatched venue for collective and comprehensive assessment of issues facing clinical data management executives and the industry as a whole.
Discussion focused on topics at the forefront of the industry, including the role of CDM in the larger dialogue of health care, creating effective partnerships and FDA views of risk assessment.
"The strategic agenda, diverse and senior leadership in attendance, engaging and high-level speakers, plus an intimate setting created a great environment to debate and discuss the topics that will affect our profession in the years to come," said Gregg Dearhammer, co-chair of the Leadership Forum Taskforce. "This Forum truly offered something for everyone who leads a CDM organization."
Nearly 70 top leaders in the clinical data management industry attended the conference, held March 15-17 in Nashville. Through presentations, panel discussions and interactive sessions, they developed a deeper understanding of issues facing the industry and the strategies needed to meet those challenges.
SCDM members can access the presentation slides from the Leadership Forum in the Members Only section of the SCDM Web site.
The Leadership Forum Taskforce would like to thank all who attended and contributed to this event's success. A special recognition to the speakers who shared their knowledge and experience:
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Joseph Anderson Barbara Cannon Paul Clarkson, CCDM Anthony Costello Charlene Dark, CCDM Carol Garvey, CCDM Rob Goodwin |
John Haley Tom Moreno Armand Matejunas Jonathan Perlin, MD, PhD, MSHA David Reasner, PhD Linda Talley, CCDM Katherine Vandebelt |
If you are interested in helping plan the 2010 Leadership Forum, please contact SCDM at 414.226.0362 or info@scdm.org.
Preparing for the CCDM® Exam: An Insider's View
Learn the ins and outs of applying, preparing and sitting for the certification exam from Certified Clinical Data Managers who have experienced it all.
- Why be certified?
- Setting up the appointment
- Notification of results
- Logistics on exam day
- Test taking strategies
- Preparation resources
- Forming a study group
If you missed the free live presentation, you can view the recording to assist you as you prepare for the CCDM® exam.
Contact Sue Abrahms at sabrahms@scdm.org for more information.
SCDM is accepting articles for the summer issue of Data Basics.
The theme for this issue is Leadership/Project Management. The submission deadline is April 6. Please contact SCDM at 414.226.0362 or info@scdm.org for submission requirements.
Suggested topics:
- Clinical data managers (CDMs) as project managers (PMs)
- How are these roles different/similar? How can we effectively develop CDMs into PMs and vice versa?
- What tools can help us manage effectively as a PM? What role can timeline management software play (i.e. MS Project)?
- What are pitfalls to avoid when practicing true PM skills?
- Industry trends reshaping clinical data management and its leadership
- How do company buyouts/mergers affect the average CDM? What should be expected when departments are merged under central leadership (i.e. biostatistics merged with CDM)?
- What are the benefits/limitations of a technical vs. leadership career path?
- How is the current state of the economy affecting companies (sponsors, service organizations, etc)?
- Have six sigma principles been implemented? What were the lessons learned?
- What is senior CDM leadership's view of the future of the industry? What do other functions see as the future of CDM (next five years, 10 years, etc.)?
Upcoming Webinars
| Date | Title | Sequence |
| April 23 & 30 | Data Query Processing & Tracking | Certification Sequence |
| June 4, 11 & 18 | EDC Today and Tomorrow | Certification Sequence |
| July 9 & 23 | Emerging and Established Standards | Career Development Sequence |
| August 13 & 20 | Patient Reported Outcomes | Career Development Sequence |
| September 10 & 17 | Database Validation and Surviving an Audit | Certification Sequence |
| November 5, 12 & 19 | Project Management Toolbox | Certification Sequence |
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 volunteers@scdm.org.
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 Vendor Management, Data Acquisition, Edit Check Design Principles and Project Management for the Data Manager. Please respond no later than April 15.
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.
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
Share your CCDM® Study Group Best Practices
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.
Volunteer Opportunities
SCDM encourages members to become actively involved in the organization. Volunteering is an excellent way to advance your professional development and broaden your network of professional colleagues.
Click on the taskforce listed for a detailed description of volunteer opportunities.
Products and Services Committee
Education and Professional Development
Marketing and Communications
If you would like to volunteer, please contact volunteers@scdm.org.
SCDM Board of Trustees Update
Spring has finally arrived, unless you are in the northern plains. Here in the greater Philadelphia area, flowers are blooming and we are having intermittent days of warm, sunny weather.
The 2009 SCDM Leadership Forum was held March 22-24 in Nashville, TN. Sixty-four CDM executives and other leaders were in attendance. Numerous exciting topics were discussed including the use of electronic health records and implications for industry, future roles for data managers and approaches to risk management and new FDA Initiatives. The good news is that even those outside of the industry feel that data managers have the skills for the future. Attendees at the meeting came out feeling very positive about the future of data management.
The Board of Trustees met in Nashville prior to the Leadership Forum. We had a very worthwhile meeting. Topics for this meeting focused on how we can ensure the organization's financial health and how we can best show value to our members. We now meet with the committee chairs and co-chairs for at least an hour at every Board meeting. This is usually via teleconference but may be in person at the spring and fall meetings that correspond with our educational conferences. All have found this worthwhile to make sure that we are on track to meet our goals and priorities.
It was particularly encouraging to hear that our current membership stands at 2,800. Eighty-nine percent of our members are from North America. It is important to note that SCDM's international presence is growing; we have members from the following countries: Argentina, Australia, Austria, Bahamas, Belgium, Canada, Croatia, Denmark, Finland, France, Gambia, Germany, Greece, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Kenya, South Korea, Luxembourg, Malaysia, Mali Mexico, Netherlands, New Zealand, Nigeria, People's Republic of China, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom and, of course, the United States. We are becoming truly global in our work. Our colleagues from other countries have unique challenges and opportunities to share with us.
Please don't forget to mark your calendars for the 2009 SCDM Annual Conference, October 4-7 in Seattle, WA.
Susan K. Howard
Member, Board of Trustees
Therapeutic Program Manager
Oncology Data Management
GlaxoSmithKline
Get to Know the CCDM®
SCDM is proud to introduce Subhash Choudhary, CCDM, as a recent recipient of the Certified Clinical Data Manager designation. Subhash is a manager of clinical data management with Roxaane Research Limited in Chennai, India.
| Q: | Why did you become certified? |
| A: | Becoming certified adds value not only to your profile but also to your employer and demonstrates my commitment to clinical data management as a domain. The stamping of CCDM® provides great recognition in the CDM community, CRO, pharmaceutical and biotech industries, as well as increases employability. Having CCDMs in a CRO provides additional confidence to the clients that their projects are in safe hands. I also wanted to know where I stand in terms of skills and knowledge in CDM and the areas on which I need to focus more to deliver much better. |
| Q: | What challenges did you have taking and studying for the exam? |
| A: | I personally feel that practical knowledge is key to clear this exam. Good Clinical Data Management Practices (GCDMP) and other reference books and regulatory guidelines are also valuable since the exam covers the entire spectrum of CDM activities - and it's very difficult to get an opportunity to work in all these areas. I learned from the SCDM Web site that the questions would be largely based on practical scenarios rather than straight-forward questions from the references. Therefore, it became very important to brush-up my past working experience and to explore the areas to which I had not been exposed. |
| Q: | How has being certified benefited you? |
| A: | By becoming certified, I gained a sense of personal satisfaction that I have achieved an important milestone in furthering my career and made myself and my current organization more marketable in the data management industry. I also feel much more confident than ever before.
Moreover, studying for the exam forced me to once again go through GCP and other ICH guidelines thoroughly and enabled clearing my pending doubts. Apart from these benefits, I did incur a monetary loss by hosting a celebration party. Just kidding. |
| Q: | What materials did you use to study for the exam? |
| A: | I relied on SCDM's Good Clinical Data Management Practices (GCDMP) and Data Basics, as well as resources from CDISC, IHC, FDA and various trade articles.
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| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: | Familiarize yourself with all areas of data management. Start preparing well in advance rather than reading everything in 10-15 days. Focus more on your weaker areas by reviewing literature and interacting with subject matter experts in your organization. Participating in online clinical research discussion forums or communities is also helpful. Start every day with a mindset that you are still a fresher in this domain. |
| Q: | Any additional comments you would like to provide? |
| A: | I am thrilled to get the title of CCDM®! Thanks to SCDM!
I have learned a lot from and will always be obliged to my previous organizations (Manipal AcuNova and Quintiles). Also, I thank my colleagues, peers, superiors and supervisors for their guidance and support. Last but not the least, I would like to thank Dr. M. Vasudevan, President, Roxaane Research Limited, India, for providing me with some of the vital study resources and tremendous support and time for preparing for this exam. I hope I will be able to encourage and guide others within my organization for this exam. |
Save on Registration for e-Clinical Trials Conference
VIB events' ninth annual e-Clinical Trials conference will explore the critical challenges and latest developments companies are currently facing when using electronic systems within clinical trials.
SCDM members can save 10 percent off the registration costs for the conference, which is scheduled for May 13-14 in London. To receive the discount, mention your SCDM affiliation when registering or inquiring.
This year's conference will focus on how the e-clinical mix is improving the functional areas of clinical trials and on how manufacturers can maximize their cost savings.
Complete event details and a full conference schedule are available online.
Register online or by contacting VIB events at events@vibevents.com.
Leadership Institute Offers Program Discount to SCDM Members
It is essential for technical professionals to perform leadership and communications tasks at optimal levels.
Receive a 30 percent discount when you register for the Science and Technology Leadership Institute's Intelligent, Bottom Line Leadership Training for Information Architecture, May 18-19 in Cambridge, MA.
This Institute program will enable participants to improve their leadership and communications skills, with an emphasis on leading teams of technical professionals and connecting with customers.
The Institute program also delivers excellent lasting results because it includes two customized follow-up activities - a post-program 360 Survey provides participants with objective feedback on their own communications style and effectiveness; and two individual one-hour coaching sessions enable participants to apply new approaches in their everyday work.
For more information, visit the Science and Technology Leadership Institute's Web site.
SCDM welcomed these NEW members in February 2009!
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RicJunette Addie, BS Kim Allen Draga Andonovska Debra Bagan Gladis Bamba Joel Banks Margaret Becker Loura Berlen Kimberly Blankenship Evan Bliss Jessica Bok Aimee Bolen Jill Bowers Patrica Boyd, PhD Lolita Braden Kimberly Brown Joy Bullock, CRS Patricia Burden-Brady Selma Cardenas, MD Hillary Castaneda Susan Chrusciel Lisa City Lawrence Cobb Cynthia Covington Eshwar Das, MS Carrie DaSilva Shannon Day Anvella Deng Rosetta DeSheilds Susan Desovic |
Tecia Dimond Nalantha Durairaj Lori Fenner Benjamin Finkel Ann Fowler Shawn Franke, BS, CCDM Lorraine Freeman David Friend, MT, ASCP Shrikant Gawande Kenneth Gilmartin, BSS, CCRP Stephanie Guina Patricai Guiney Zebiba Hassen Helen Hayes Amy Hayward Patricai Hazelgrove Liang He Barbara Hewett-Osterhot Robyn Homer, BA, BS Erika Horan Molly Hummel Karmin Jackson Shaheda Jamil, CCDM Deana Jelley Eugene Johnson Sunita Joseph Kristal Kingsley Kris Kirkpatrick Nandini Kumar Michelle Ledford |
Adriana Licona-Garcia, BS Susan Light Ian Marsh Jennifer Martin Molly Mast Patricia Michael Laura Mihankhah Jennifer Miller Jessica Miller Barbara Nagaraj Amit Naik, BS, CCDM Michelle Noel Sarah Parsons Steve Parsons Rakesh Patel Chot Patsakham Tiffanie Pederson Greg Pfeiffer Dorothy Presutti William Primwhere Jody Ann Rainbolt Maria Raya Jenny Rayner Andrea Rice Deborah Robertson Eboni Russell, CCDM Munim Saeed, CCDM Kate Sandler Carmen Saylor Indrani Sen |
Maulik Shah Dianna Sharp Luba Shtipelman, MD Jennifer Showalter Kelley Shrum Reta Shulman Edward Slezinger Anne Smith Kristine Smith, CCDM Calvin Stewart Cindy Stoner Jared Stull Margaret Suraf Darren Svetlik Mark Talbert Admire Terry Elizabeth Thorndyke Jun Tian Patrica Touil Micah Tragesser Denis Vacek Richard Vachal Sushama Wooravakonda Radhika Yalamanchili Stephanie Young David Zhu, CCDM Chuan Zhu, SCDS |
SCDM congratulates the following members for entering
their 5th year of membership in February 2009!
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Herman M. Berenguer Elena V. Kalita, CCDM, MsRA Mel Liebelt |
Alanna Mohan Sveta Patel, CCDM Heidi Saunders |