First Look: 2009 Annual Conference
Join us at the 2009 SCDM Annual Conference, October 4-6 in Seattle, WA, for educational presentations (and a few social events) that will expand your understanding of the latest developments in clinical data management.
Our call for abstracts was met with record interest - more than 220 submissions were received. The Annual Conference Taskforce has narrowed this field to 40 high-quality, diverse presentations. We are confident that this meeting will offer valuable, interesting information to CDM professionals at all levels.
Planned highlights include:
- Engaging and thought-provoking featured speakers
- Productivity expert Laura Stack
- Diane Jorkasky, former President of Clinical Research Operations at Pfizer Global R&D
- Our 2nd Annual SCDM-FDA Forum
- An exciting Data Driven Awards Reception at the Experience Music Project/Science Fiction Museum (empsfm.org)
- More than 40 presentations from your peers on a wide range of topics of interest to CDM professionals at all levels
- A selection of pre-conference tutorials on Sunday
- Information about the latest products and services in the Exhibit Hall
- Opportunity to earn continuing education units (CEUs) toward Certified Clinical Data Manager (CCDM®) renewal
Annual Conference registration opens June 1. A preliminary program will be available online June 1. Mark your calendar now and get ready for this great opportunity to learn, share and network at the 2009 SCDM Annual Conference.
Join the conversation. Find SCDM on social network sites.
The Society for Clinical Data Management is making it easier for you to discuss industry developments, connect with colleagues, make new contacts and get the latest SCDM news.
We invite you to find us online and join the conversation. Follow the links below to get started. If you don't already have an account, you'll be prompted to create one — it's free and easy!
On Facebook? Become a fan of SCDM.
LinkedIn? Network through SCDM's group.
There is also a special LinkedIn group for CCDMs.
Sign up to follow SCDM on Twitter (@SCDM_DataDriven) for short, timely SCDM updates.
We're just getting started. In coming months, SCDM will be creating new groups designed to meet your specific networking needs.
We welcome your feedback. Please forward any questions, comments or suggestions to Kimberly Jahnke kjahnke@scdm.org.
Please note membership in the CCDM LinkedIn group is restricted to those holding the CCDM® designation.
SCDM Leaders Build Global Strategy
SCDM Executive Director Eloiza Altoro-Acevedo and Past-President Jonathan Andrus recently attended the American Society of Association Executives (ASAE) Associations International Conference in Washington, DC. The conference explored the challenges, considerations and keys to success for taking an association global. SCDM is focused on expanding our reach to clinical data managers around the world. The Board of Trustees is actively working on formalizing partnerships and strategies to pursue this goal. The ASAE conference provided proven models, alternatives and resources to guide SCDM on how to proceed with our efforts.
Impact Survey invitation
SCDM will be collaborating with the American Society of Association Executives and the Center for Association Leadership (ASAE and The Center) as they conduct an impact study, on Beliefs, Behaviors and Attitudes in Response to the Economy.
As a member of SCDM you may receive an e-mail inviting you to take part in this volunteer survey. We encourage you to participate as SCDM will be able to utilize the results of this study to better meet the needs of its members. Stay tuned for a future issue of Data Connections, where we will share with you some of the survey results and a link to the full report with detailed findings.
Look for the survey to arrive from ASAE and The Center the beginning of June!
Master Data Management Plans through Online Course
SCDM is excited to offer a new opportunity to CDM professionals looking to expand their understanding of data management plans.
A new eight-week online course will review documentation requirements and common practices and include examples and exercises using a fully developed training protocol. Online group discussions will be facilitated to benefit from common experiences and practices across organizations. A group project will provide students with experience in creating a data management plan.
The Data Management Plans course runs June 8 through July 31 and is led by Anita Walden of Duke Clinical Research Institute. Registration opens Wednesday, May 6, through the SCDM Education Portal. Enrollment is limited to 20 participants. Watch your e-mail inbox for updates.
Learning objectives
Upon completion, participants should be able to:
- Define key elements in a Data Management Plan
- Gather and organize the information describing the data handling processes used for a clinical trial
- Describe workflow for electronic and paper data capture, quality control and related data processing procedures and metrics
- Discuss clinical data management documentation requirements and rationale
- Apply standards for creating, approving and maintaining Data Management Plans
About online courses
Our online learning courses are specifically designed for adult students seeking to balance their professional, personal and student lives. Unlike a traditional class that meets at a designated day and time, students are allowed one week to complete each lesson. You set the schedule; all materials are accessible any time of day or night. Estimated weekly time commitment is 10-12 hours per week to complete each module.
Continuing education
SCDM is authorized by IACET to offer CEUs for this program.
More information
Check the SCDM Education Portal for updated information.
Preparing for the CCDM® Exam: An Insider's View
Learn the ins and outs of applying, preparing and sitting for the certification exam from CCDM®s 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 Certified Clinical Data Manager (CCDM®) exam.
Contact Sue Abrahms at sabrahms@scdm.org for more information.
Recent Data Query Webinar Available in Archives
Our Data Query Processing and Tracking webinar has concluded, but that doesn't mean you've missed this valuable opportunity to learn tips for improving the quality of your data.
The archived webinar is now available for purchase through the Education Portal of the SCDM Web site.
This two-part webinar provides a general overview of the query process, followed by in-depth exploration of the challenges faced by data managers.
Here's what some attendees had to say:
"This was the best webinar I have attended for data management. The material was related to real experiences from people who have actually experienced it."
"It confirmed some processes I thought that I understood and provided a clearer explanation on those that I did not."
Read on for a schedule of upcoming webinars.
2009 Webinar Schedule
| Date | Title | Sequence |
| May 14 | Overview of Emerging and Established Standards | Career Development Sequence |
| June 4 & 11 | From Protocol to Collection to Submission - Putting CDISC Standards to Work for You | Certification Sequence |
| July 9, 23 & 30 | EDC Today and Tomorrow | Certification Sequence |
| August 13 & 20 | Patient Reported Outcomes | Career Development Sequence |
| September 10 & 17 | Database Validation and Surviving an Audit | Certification Sequence |
| October 22 & 29 | CDASH User Guide | Certification Sequence |
| November 5, 12 & 19 | Project Management Toolbox | Certification Sequence |
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.
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, Project Management for the Data Manager, Database Closure, Metrics for Clinical Trials, Systems Validation/Systems Auditing and External Data Transfers.
There is an immediate need for Data Acquisition and Project Management for the Data Manager. Please respond by May 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 guidance
- 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.
New Opportunities for Volunteers
Help develop industry-leading educational programs and shape the future of clinical data management. SCDM is now seeking volunteers for two exciting new opportunities:
Webinar Sub-taskforce
Determine topics for 2010 webinars, identify presenters and guide content. Group will begin meeting in June.
Online Courses Development Sub-taskforce
Determine topics for online courses and review content. The first teleconference meeting is scheduled for 11 a.m. (CDT) May 13.
For more information or to volunteer, send your contact information and interest area to volunteers@scdm.org.
Unique Leadership Opportunity Offers a Chance to Contribute
The Membership Taskforce has an immediate opening for a taskforce leader. Influence the future of SCDM and gain valuable experience through this exciting role.
Taskforce goals
Increase retention and recruitment of SCDM members by:
- Identifying demographics of SCDM members and using this information to reach out to prospects within and outside of data management
- Conducting and analyzing surveys to provide value through membership benefits, meeting needs and international membership campaigns
- Sharing information with other volunteer leaders to assist in marketing efforts
Responsibilities
Coordinate taskforce activities, including:
- Prepare agendas and lead Membership Taskforce conference calls, currently held at 12 noon on the first and third Wednesday of the month
- Work closely with SCDM staff liaison to implement taskforce goals and objectives
- Collaborate with the Products & Services Committee co-chairs on taskforce objectives and progress
Benefits of volunteering for SCDM
Professional and personal development:
- Networking opportunities with other CDM professionals
- Direct impact on enhancing member values and benefits
- Participation credits toward CCDM® renewal
- Practice your leadership skills
- Enhance your resume
If you are interested in serving as a Membership Taskforce Leader, please contact Kat Gál at 414.226.0362 or kgal@scdm.org.
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.
CCDM® Industry Rewards 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
- Cleveland Clinic Vascular Surgery Academic Coordinating Center
- McDougall Scientific Ltd.
- ClinForce LLC
- Kestrel Consultants, Inc.
Industry Champion — 50% of CDMs are CCDM®s
- Cetero Research
Industry Leader — 25% of CDMs are CCDM®s
- Covidien
- Duke Clinical Research Institute
- Enzon Pharmaceuticals, Inc.
- Innovative Analytics
- Phoenix Data Systems, Inc.
- ResearchPoint
SCDM Board of Trustees Update
This is a very unusual time in our industry. Many of our colleagues have been laid off or are worried about the potential of losing their jobs. There are multiple reasons for this situation. The most obvious reason is the current economy. Other reasons include recent mergers and acquisitions and one issue we all have faced in this industry - failure of a drug to progress for either safety or efficacy reasons. Additionally, sites, CROs and vendors are being affected by companies reviewing all of their work and making tough budgetary decisions as to which trials are most important. I have never seen such tough times in my 15 years in the industry.
During these challenging times, networking becomes more important. Your colleagues may know of job openings prior to official postings or may know when someone is hiring a position that could be filled remotely. I encourage you to stay in touch.
Your SCDM membership may be even more valuable now. As an SCDM member, you can download the GCDMP document for free. You can keep your knowledge current by periodically reviewing chapters. Everyone complains they never have time to stay up to date on their profession. Make the time now. Join the SCDM DataMatters Listserv and start or contribute to conversations with others in the profession. Review documents in preparation for the CCDM® exam. Write to your Board of Trustees and let us know how we can better serve you. We want to know.
Watch for news in Data Connections about our new online career center. We think this will benefit our members and companies looking for staff.
On a positive note, experts are predicting that the economy is getting stronger. Let's all hope they are right and that May brings opportunities for those seeking them.
Susan K. Howard
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Raja Warfield, CCDM, as a recent recipient of the Certified Clinical Data Manager designation. Raja is a clinical data analyst with Cytokinetics, Inc., in South San Francisco, CA.
| Q: | Why did you become certified? |
| A: | Professional recognition from my colleagues. Working in a small biotech company, our department isn't very big but we are responsible for very big and important projects. I work closely with upper management daily and I wanted to be perceived as competent. This certification recognizes my "knowledge, education and experience" and goes a long way to support that perception. I'm also looking toward the future in terms of industry recognition |
| Q: | What challenges did you have taking and studying for the exam? |
| A: | I decided to take the Beta version late in June and I was a little pressed for study time. I have gone through certifying professionally for my CCRP years ago and since that took six month in a group effort I needed to organize. I posted to SCDM's members Discussion Forum (now DataMatters listserv) for interested parties to form a local study group and received several responses. As a group we organized materials, assigned individual study projects to be presented and met as often as possible. Working full–time through an interim analysis was a challenge to finding the time, energy and motivation to keep studying for the exam. |
| Q: | How has being certified benefited you? |
| A: | It's too early to tell, but I know there were skeptics here at work and it was nice to prove them wrong. |
| Q: | What materials did you use to study for the exam? |
| A: |
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| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
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| Q: | Any additional comments you would like to provide? |
| A: | Work hard and good luck! |
SCDM welcomed these NEW members in March 2009!
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RicJunette Addie, BS Draga Andonovska Kathi Adolph Kim Allen Raquel Allen Draga Andonovska Ullas Arabhavi |
H. V. Ashwath Jeong Bae Jody Breneman Walter Briggs Shubha Chaudhari, CCDM Cynthia Craft Joe D'Antonio |
Karin Daun Telsa De Lange Angela DeLoe Mary Ellis Penny Eyer Menka Favhane Greg Fegan |
Sandra Frazilus Carol Gamble Ella Guillaume William Harel Mie Iwaida Tracy Keys Kovuru Maheshwar |
SCDM congratulates the following member for entering
his
5th year of membership in March 2009!
Arjun Roy
SCDM congratulates the following member for entering
her
10th year of membership in March 2009!
Lori Nowland, MS
