Join the SCDM Board of Trustees
Your vision and leadership are needed to guide the future of SCDM and the clinical data management industry. Complete an application or nominate a colleague by July 19.
All SCDM members are eligible to apply for the board. New trustees will be elected by the membership in August, with results announced at the SCDM Annual Conference in October.
Eligibility and Process
All SCDM members are eligible to serve on the Board of Trustees. Members may nominate themselves or other SCDM members as candidates. Please carefully review the Board of Trustees Fact Sheet and the SCDM strategic plan prior to submitting your nominations.
All nominees will be required to complete an application. Applications will be reviewed and approved by the Nominating Committee prior to announcement of the final slate of candidates Monday, August 2.
Virtual voting will open Monday, August 2, and close Friday, August 20, via the Members Only section of the SCDM website. Election results will be announced at the 2010 Annual Conference, October 17-20.
All Board members are required to attend four face-to-face meetings per year. Board members are expected to cover their costs for transportation and lodging for these meetings. Additionally, board members are invited to attend a Board orientation and the Board meeting held at the 2010 Annual Conference on Saturday, October 16.
SCDM Online Course
Metrics and Identifying Data Trends
Enrollment is limited - Register today!
Course begins June 13
This asynchronous online course has been designed for anyone directly involved with managing EDC or paper trials. It assumes that learners will have some basic clinical research knowledge including the importance of metrics. The course will provide a more expert level of detail in following the flow of CRF data through defined process, and understanding data trends within the data that has been collected. Participants will have opportunity to practice applying what they learn.
Over four weeks, the course will address general principles, best practices and issues to consider for establishing metrics of CRF flow. Standards and compliance for tracking data will be detailed in depth. Collaboration and communication with appropriate team members during all phases of clinical trials will be highlighted.
Module 1: What are Metrics?
Module 2: Implementing Metrics for Clinical Data Management
Module 3: Interpreting Metrics: Identifying Workflow and Tracking Trends
Module 4: Identifying Data Trends During the Validation Process
For further information and to register click here
SCDM 2010 Annual Conference
Registration Opens June 14
Preliminary program information available June 14, detailing preconference tutorial options, session information and networking opportunities for all attendees. New to 2010, intermediate and advanced tracks available to better fit your learning expectations.
Is Your Company Looking for Ways to Gain Exposure?
Become a 2010 Annual Conference exhibitor or sponsor. Our most popular sponsorship opportunities are selling quickly. Reserve your sponsorship now to guarantee your choice of giveaway items. Remember, conference sponsors also get premium booth location!
Increase your company's exposure entering the 2010 Data Driven Innovation Award program. All exhibiting and 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.
Questions? Contact Jean Wenzel at 414.226.0362 or jwenzel@scdm.org.
Overall Clinical Trials Process, Roles and Responsibilities
June 17 & 24 11 a.m. CDT
60-minute presentation followed by 30-minute Q&A
This program will provide you with an overview of the clinical trial process from study design through database lock and those roles, tasks and activities for which Clinical Data Managers assume responsibility. The roles and responsibilities will be defined to ensure clarity at the task and process level, as well as expected interactions and communication with the overall project team.
At the conclusion of the program you will be able to:
- Describe the clinical trial process from study design through database lock
- List roles and responsibilities for data management functions
- Describe the methods of managing processes and tasks
- Describe the expectations of communicating with the cross functional areas of the project team
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| Metrics and Identifying Data Trends | June 13 |
| SAE Reconciliation, Safety Review and Coding | July 25 |
| Managing Lab Data | September 5 |
| Database Lock and Randomization | October 10 |
| Project Management for the Clinical Data Manager | November 7 |
| 2010 Webinar Schedule | |
| Overall Clinical Trials Process, Roles and Responsibilities | June 17 & 24 |
| Vendor Management | July 15 & July 22 |
| Protocol Review | August 12 & 19 |
| Touch Point/Hand Offs (with SAE Reconciliation) | September 16 & 23 |
| CDISC | November 11 & 18 |
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.
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.
| 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 will be guided by an experienced instructional designer. As an added benefit, you will learn about the process of creating online courses and even be rewarded with participation credits that count toward renewal of your CCDM.
To apply, please send the following to schaplock@scdm.org:
- short paragraph outlining why you want to join the team
- your qualifications
- the course you'd like to work on
- a copy of your resume or CV.
Get Published - Share Your Knowledge
Are you a data management professional with knowledge to share with the rest of the industry? Are you involved in a project that would be of interest to other SCDM members? Share your experience or expertise by authoring an article for a future issue of Data Basics. Topics vary from data quality to pharmacogenetics to metibolomics and other related topics.
Not sure where to start? Read Writing for Data Basics for our guidelines.
The submission deadline for the next issue of Data Basics is July 6.
We look forward to receiving your article!
Call for Study Group Task Force Volunteers
Have you ever joined a study group to prepare for an exam or deepen your understanding of coursework? If you have, you know how valuable they can be in bringing a diverse group of people together to share their knowledge and experience. Tips for studying and exam taking, as well as discussions of key concepts and case studies are all part of the study group experience. It is also a very productive way to prepare yourself for the CCDM exam. SCDM is looking for volunteers who want to help design a study group experience that can reach out to all, no matter where people happen to be located.
If you are interested in joining the team to create SCDM study groups for the Certified Clinical Data Manager certification exam, please contact Sharon Kayne Chaplock, Director of Education at schaplock@scdm.org. Include a short paragraph about your experience with study groups - participant and/or host - and why you want to join the study group design team. Work on the formation of study groups will begin in July.
BoT Update®
May is a relatively quiet month for the Board of Trustees. It is not hectic yet in preparation for the Annual Conference and our next full Board meeting is in mid-July. We will finalize our plans for that meeting sometime in June.
If you haven't been to the website for a while, I suggest you check it out. There are now easy links to all of the professional development opportunities that we offer. We also have a quick link for volunteer opportunities with SCDM. The link for GCDMP Subject Matter Experts lists the chapters we are planning to work on in the near future and need experts. The Presentations link will take you to a list of future webinars for which we are recruiting presenters. Our Publications link will provides you with a contact for further information regarding editorial guidelines and an editorial calendar. The link for Taskforces and Committees provide you information on how to join or become a Taskforce leader.
Susan K. Howard
Secretary
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Lydia Akalesto, BSc, CCDM, as a recipient of the Certified Clinical Data Manager designation. Lydia is Clinical Data Manager with Concordia University in Laval, Quebec.
| Q: | Why did you become certified? |
| A: | I took the exam because of the personal and professional benefits as well as the acknowledgement of value and advantages that come with being certified as well as the CCDM status establish me as a leader in the industry.
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| Q: | What challenges did you have taking and studying for the exam? |
| A: | Having worked for a large pharmaceutical company, the positions/ roles are very structured and since then facing re-organization, I was left with the task of studying on my own and reviewing all the competencies that I was not entirely familiar with. I had to focus on industry best practices separating them from company specific practices. |
| Q: | How has being certified benefited you? |
| A: | As a CDM trainer, becoming certified has been my career goal for 4 years and even though I have the experience and training, I am now able to advance to the next level with confidence because of the recognition of SCDMs certification program which allows me to keep up with industry standards and train others to do the same.
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| Q: | What materials did you use to study for the exam? |
| A: |
I used the GCDMP (Manual and Podcasts), Practical Guide to Clinical Data Management by Susanne Prokscha, ICH Guidelines 21CRF 11, Project Management Book of Knowledge (PMBOK) and Relational Databases for Mere Mortals and any online resources. Finally, take the practice 'Self Assessment Tool' on the education Portal. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Review all the core competencies, focus on the topics that you are not familiar with, consult peers and take notes. I set aside 3-4 weeks for full time study since there are 3 sections outlined in the competencies. During the exam, manage your time, answer the easy questions first and flag the difficult ones, take advantage of the entire 3.5 hours and review at the end.
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| Q: | Any additional comments you would like to provide? |
| A: |
Good luck to all and don't give up!!! Congratulations to all new CCDMs!!!
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Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to Sue Abrahms at sabrahms@scdm.org.
SCDM welcomed these NEW members in April 2010!
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Elizabeth Olubukola Adeniran Tracy Balentine Russell Cender Daniel S. Chapple, PhD Susan M. Christopher, BS Nicole Coggins Heather Cosman Jerel Crew Emmalee Crow Gloria Crowl Tiffany Daniel Jaime De Blas Lop Sheila Dennis Amanda L. Dey, CCDM Kim Dukes Candace R. Edwards, CCDM Ginika Egesimba Kimberly R. Ellis, MBA Michael Elmshøj Lora L. Gay Gathari Ndirangu Gichuhi Cindy CG Gratto, Sr. Susan Green Sue Gregory David A. Gurley Mark Haemmerle Nam Ho Cindy Cindy Huang Fred Jacome MinGeol Jang Lucie Jindrova Rose Johnstone Darshit V. Joshi Steven E. Kalloger Ramana Kuchibhatla, CEO David J. Lee Janae Lehto Lisa Lopez Wendy Mack Norah Mawoko Stella McDonald Melissa Millet Joao Miraglia Gary Molino Gudalupe Montano |
Lieuwkje Mooney Carol Wanjiku Ndungu Catherine Judith Njeri Raul Nunez Shifana Nuraney Alexey V. Odintsov Gayle O'Neil Maricianah Atieno Onono Justyna Monika Oracz Tina Patel Luce M. Penney Erin Phillips Cheri Raffo Noorani Sherali Ramji Jamie Ramsey Rafael Romero, eMBA Lisa Ruehr David GC Rutt JT Rynak Aimee Sargent Rudy Scholte, MSc Cindy L. Schreiber Betty Anne Schwarz Jamie Lynn Selbie, MS Shanmugavel Shanmugasundaram Mark A. Shapiro, MA, MBA Lorraine F. Sharon, BS Simon J. Shortt Rashmi Sidharthan Lawson Simapuka Joel Singer, PhD Karl Smith Nicci Smith Travis Smith Linda Cecilia Soloshy Stephanie Starr Christele M. Strowder Michelle Taylor Michelle Taylor Francis B. Verissimo, II Nina Walker Sherese Woods Cynthia Woolery Srinivas Yereneni, Sr. |
SCDM congratulates the following members for entering
their 5th year of membership in April 2010!
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Carolyn Alimecco, MS, MT(ASCP) Stephane Bertolini, PharmD Tami Bowman Donna Brungo-McCabe, AA Paul Comer, CCDM Shelly Davis, MA Renee Flak Chip Gettys, BS Joan L. Goldblatt Kristie Harris |
Aminta Susana Jimenez, CCDM Andrea Lazevnick Mary Mattes Carrye Nibbelink Theresa Perry Sherry Powell, BA Sean Quigley, BS Stephanie Shifflett Susan K. Wilson |
SCDM congratulates the following members for entering
their 10th year of membership in April 2010!
Rebecca A. Bond, CCDM
David Borbas
Tina M. Sinnett
ACRP issues 2011 Global Conference & Exhibition Call for Proposals
The ACRP 2011 Global Conference Planning Committee seeks proposals for the 2011 ACRP Global Conference & Exhibition, with the APPI Physicians Program, in Seattle, Washington, April 29-May 3. Proposals must be submitted online no later than June 14, 2010, 11:59 p.m. EDT.
New among proposal topics this year is Clinical Data Management. The committee encourages submissions of advanced-level content with appeal for the highly skilled clinical research professionals who attend this conference.
To find out more, visit www.acrp2011.com
Top 5 Reasons to Attend the 6th Leveraging Healthcare Technology to Monitor &Leveraging Healthcare Technology to Monitor & Improve Clinical Outcomes Improve Clinical Outcomes conference:
- ExL Pharma's Leveraging Healthcare Technology to Monitor & Improve Clinical Outcomes Conference was the original and continues to be the only industry conference focused on the convergence of clinical research and clinical care.
- This event has become an annual gathering for HIT leaders across all industries.
- Only event built upon case study examples of actual and pilot programs demonstrating the benefit of convergence to patient, physician and pharma.
- The unique audience features an intimate gathering of influential decision-makers and visionaries from pharma, healthcare, academia, technology providers, regulatory and standards bodies, nonprofits, medical centers and several others providing an ideal opportunity to share and discuss new ideas to achieve interoperability.
- Learn strategies for leveraging government funded HIT initiatives to expedite convergence.
SCDM Members Save on Central Labs East Event
Central Labs East, taking place September 20-22 in Boston, MA, is the only place for central lab outsourcing and data management professionals to improve their relationships with central, ECG and imaging labs partners. Save your company millions of clinical development dollars and reduce cycle times without compromising quality.
- Take lab relationships from transactional to true partnerships by establishing clear expectations and deliverables from the beginning
- Obtain over 20 examples of how to streamline core lab processes to reduce unnecessary and unexpected trial costs and delays
- Ensure first-time quality and seamless data integration during four intense hours of case studies
- Take away 15 new tools to overcome challenges specific to the most promising clinical research areas including oncology, diabetes, infectious disease and cardiac safety
- Drive down costs and improve quality of global trials during strategic sessions on doing business in China, India and Latin America
- Network and team build during 25 hours of interactive learning formats
SCDM members receive 25% off the cost of registration with code XPSCDM. Register online.
A Henry Stewart Briefing on Effective R&D SOPs, Process Maps & the Quality System
*Detailed *Comprehensive *Practical * Relevant *Essential
September 14
Washington, DC
"This is an essential briefing of extreme value"
Marie-Christine Poisson-Carvajal
Clinical Project Manager, Core Clinical Sites
Pfizer Global R&D
This one-day interactive briefing goes well beyond an introduction to the basics of SOP writing. It covers:
- Latest methodologies, approaches, tools and technology for the development and implementation of R&D SOPs
- Latest thinking on best practice
- What industry leaders are already doing, and what everyone should be doing, to ensure effectiveness, efficiency and Quality Assurance.
A briefing essential for all pharmaceutical R&D management and staff responsible for or involved in the development, review, implementation and maintenance of SOPs, SOP Training and the overall Quality System.
- SOP writers
- R&D functional area / department managers
- QA Auditors
- QA Managers
- Training managers and training staff
Full documentation will be provided to all participants and adequate time allocated for questions and current best practice discussion. For further information visit http://www.hsconferences.com/page12631354.aspx or contact Julie Kerry at juliek@henrystewart.co.uk
