Free DMP Online Course Information Session Tomorrow
Meet Anita Walden, Instructor for SCDM's online Data Management Plans course during a free, 30-minute webinar on Tuesday, March 2 at 3:00 p.m. Central, 4:00 p.m. Eastern time. Anita will provide a brief overview of course objectives as well as describe course content. She'll explain how the online course is conducted, including participation requirements and how to be a successful e-learner. Information about registration will be provided and there will be an opportunity to ask questions. The course starts March 8 and ends April 13 and is for experienced clinical data managers. Passing a pre-test is required to enroll.
For more details, please contact info@scdm.org.
Flexible Learning to Fit Your Schedule
Data Management Plans for the Advanced Practitioner - Online Course
March 8 - April 13
Instructor: Anita Walden, Duke Clinical Research Institute
This popular topic returns in 2010 as a five-week course designed for experienced clinical data managers. This course will focus on the planning of data management processes for a trial or study with minimal discussion on how to complete data management tasks.
Through instructor-led sessions, review of examples, online discussions and a group project, students will learn:
- Key elements in a Data Management Plan
- How to gather and organize the information describing the data handling processes used for a clinical trial
- The workflow for electronic and paper data capture, quality control and related data processing procedures and metrics
- Clinical data management documentation requirements and rationale
- Standards for creating, approving and maintaining Data Management Plans
Prerequisite: All students are required to pass the pre-course tutorial. Project management experience is recommended.
Click here for more information.
Strategies for Coding Oncology Trial Data in Today's World
2-part Webinar series
March 18 & 25 - Noon EST
60-minute presentation followed by 30-minute Q&A
Overview
A working knowledge of MedDRA and WHO Drug are essential to coding oncology trial data. Strategies will be discussed to overcome the challenges of coding unique concepts found within oncology data. Implementation of the CTCAE Version 4.0 will help facilitate coding and reporting of adverse events. A frequent challenge for medication coding is combination chemotherapies which are not included in the WHO Drug dictionary to date. Utilization of the MedDRA and WHO Drug browsers provide essential tools for coding processes. Standardized MedDRA queries and standardized drug queries can be utilized for signal detection. Discussions related to future strategies to address these issues will also be presented.
Outcomes
- Explain the implementation of CTCAE Version 4.0 toxicity reporting
- Discuss of the challenges and strategies for coding chemotherapy regimens
- Explain the value of the MedDRA and WHODrug browsers
- Describe Standardized MedDRA Queries (SMQs) and Standardized Drug Queries (SDQs)
Attendees Who Will Benefit From This Webinar Include:
- Coding Coordinators
- Medical Monitors
- Drug Safety Associates
- Programmers
- Statisticians
For further information and to register please click here.
Be a presenter at the SCDM Annual Conference
SCDM is now accepting abstracts for presentation at the 2010 SCDM Annual Conference, October 17-20 in Minneapolis, MN. This is your opportunity to share your knowledge and best practices with the largest audience of clinical data management professionals.
The Annual Conference planning taskforce will select a diverse field of speakers, representing viewpoints from pharmaceutical, biotech, medical device trials at sponsor companies or contract research organizations.
Abstracts are due March 29. Download the Call for Abstracts now and start preparing your proposal. The 2010 Annual Conference program will consist of two tracks of concurrent sessions - one track for intermediate audiences; one for advanced. Generally, each session consists of three 20-minute presentations, 15 minutes for questions and five minutes for discussion.
Suggested presentation topics include:
- Management and Integration of Laboratory Data
- Clinical Site Scientific Misconduct Detection
- The Benefits of Cross-Functional Training of CDMs
- Site and Monitor Perspective on CRF/eCRF Design
- Impact of CTCAE on Coding
- Managing External Vendors from a Sponsor Perspective
For a complete listing of suggested topics, including information on how to submit an abstract, view the Call for Abstracts. View complete Annual Conference details at www.scdm.org.
Questions? Please contact SCDM at 414.226.0362 or info@scdm.org.
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| CRF Design | March 28 |
| Query Processing and Tracking/Database Updates | May 9 |
| 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 | |
| Strategies for Coding Oncology Trial Data | March 18 & 25 |
| Managing Virtual Teams | April 22 |
| Data Management Plans | May 20 |
| Overall Clinical Trials Process, Roles and Responsibilities | June 17 & 24 |
| Outsourcing | July 15 |
| Protocol Review | August 12 & 19 |
| Touch Point/Hand offs (with SAE Reconciliation) | September 16 & 23 |
| CDISC | November 11 & 18 |
Credit-Earning OpportunitiesThat Suit You Live Webinars For further information contact info@scdm.org |
On Demand WebinarsSCDM 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. |
Item / Question Writers Wanted
Volunteer 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 Certified Clinical Data Manager exam, 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 exam will begin in the first quarter of 2010 and continue until the test is ready for rollout 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 describe the GCDMP chapter(s) or topics for 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 at schaplock@scdm.org.
Enjoy Reading Data Basics?
Now is Your Chance to Contribute to the Next Issue!
| Issue | Topic | Submission Deadline |
| Summer | Virtual Teams/Project Management | April 6 |
| Fall | Data Quality | July 6 |
| Winter | Pharmacogenetics and Metabolomics | October 5 |
This is an excellent opportunity to earn SCDM participation credits toward certification renewal.
Please contact Sue Abrahms at sabrahms@scdm.org for additional information or click here.
Marketing and Membership Volunteers Needed
SCDM is in need of a few dedicated members to serve on its Marketing Taskforce and Membership Sub-Taskforce.
The SCDM Board of Trustees recently approved an ambitious marketing plan for 2010. We need the expertise of our members to help execute the strategies.
An interest in marketing is helpful, but experience is not required.
Responsibilities
Volunteers are encouraged to participate in a monthly conference call and complete some individual/small group work. This could include:
- Providing guidance on communication to CDM professionals and related audiences
- Developing membership surveys and analyzing results
- Sharing industry knowledge and perspectives
- Identifying opportunities for solicitation, advertising and partnering
Benefits
- Professional Development SCDM taskforces are a great opportunity to gain leadership experience and build your resume.
- Networking Work alongside CDM professionals with shared interests. Make new professional connections and lifelong friends.
- Make an Impact Taskforces work on focused, short-term projects. Your input and ideas shape the programs we offer.
If you are interested in volunteering or would like more information on these opportunities, please contact Kimberly Jahnke, communications manager, at kjahnke@scdm.org or 414.226.0362.
Please remember, these volunteer opportunities are open to members only. Not a member? It's easy to join.
BoT Update®
Each year, we observe a grace period, extending membership benefits to those who are slow to renew. That period is coming to an end and, if you haven't yet renewed your membership, this is the last issue of Data Connections you will receive. To avoid a lapse in your member benefits, please renew your membership now.
At our January meeting, the Board of Trustees refined our strategic priorities and reviewed our progress to ensure that we are on track toward achieving our goals. The Board is in the process of identifying benchmarks and outcomes to be able to effectively measure our success. We may reach out to our members to obtain additional information to assist us in better understanding our effectiveness. This may be in the form of surveys, focus groups or brief interviews. We also reviewed our strategic priorities and discussed additional opportunities to expand our reach.
Our Finance Committee continues to meet on a quarterly basis to review financial trends and make adjustments to our budget as needed. We are committed to fiscal responsibility.
A new and exciting update is the development of a comprehensive multi-year marketing strategy by our Marketing Taskforce. This plan will guide our efforts to market to current and new audiences. And you can help. The Marketing Taskforce is currently recruiting volunteers too.Additionally, this year, our committee chairs and taskforce leaders will help plan the future by developing product road maps - creating forecasts for our current products and planning for new products.
Many exciting things are happening to get our year started right!
Susan K. Howard
Secretary
SCDM Board of Trustees
Director of Education Sharon Kayne Chaplock
answers these common questions about SCDM online courses.
- How are the courses structured?
- What kind of course content is included in the course?
- What happens during the discussion forum?
- How are assignments submitted?
- How does the instructor provide feedback to students and stay in touch with them?
- Why are online courses good for professionals seeking to deepen their understanding of DM topics?
Click here to view the full interview on the SCDM Education Portal.
Get to Know the CCDM®
SCDM is proud to introduce Tracy Myers as a recipient of the Certified Clinical Data Manager designation. Tracy is a Lead Clinical Data Analyst with ResearchPoint in Austin, TX.
| Q: | Why did you become certified? |
| A: | As our industry evolves, I think it is important to make sure that data management standards continue to improve. By becoming a CCDM®, I can continue to be aware of and to have input into the standards. In addition, our Sponsors expect us to have this knowledge and training.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | Mainly, the exam requires you to address how you handle everyday situations. There are no study guides for this! In addition to studying the materials that were available to me, I also reviewed topics with my colleagues so when there were areas that I felt I needed additional insight, I could get their opinion or have them point me in the right direction for additional study references.
|
| Q: | How has being certified benefited you? |
| A: | I am able to demonstrate to my clients that not only do I have experience in my field, but I am qualified to effectively run a project. This certification has given me the opportunity to work on more projects that I may not have been qualified for in the past. I like to think of it as "job security." In addition, I had set becoming certified as one of my personal goals during my personnel evaluation so I was able to work with my supervisor to move my promotion to the next level.
|
| Q: | What materials did you use to study for the exam? |
| A: |
The SCDM website has several free study aids but you should also review other journals, articles, etc. that are available to you. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Take the practice exam before you study so as you are studying, your mindset will be to review the materials in terms of practical applications. When you are in the exam itself, there is a feature where you can flag a question for further review. I used this to help me manage my time better. If I found a question required more thought, I would flag it and move on.
|
| Q: | Any additional comments you would like to provide? |
| A: |
I think obtaining this certification is an excellent way to remain competitive in the workplace. As SCDM continues to move forward on data management standards, individuals who are active within the organization will be in a better position to adapt to the changes.
|
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 January 2010!
|
Aabid Abdulmajid Ahmed Ashraf Almashhrawi Ruth Adele Antonini Lisa A. Ares, AS Nitin Bagul Tyson M. Bain, BS, MS Rainer Baumann Ghiorghis Belai Dana Bembry Golda Naana Afua Boatemaa Boakye Roman Bobrovsky, PhD Deb Carullo, RN Floriana Maria Castrovinci Artale Amy Chiang, CCDM Jennifer Cockroft, MPH Lisa Y Deane Joanne Eatock Sylvester Ebaye Margaret Ekua Ekuban Sherry RoAnn Paula Ephraim Kai Fegert, MA Mejang Fon Ndikum Maeghen Germain, BA Kristen Gulish Elisabet Hoffman, MS, CCDM Mrunalini U. Jagtap, CCDM, BE Kelli Jarivs Thomas John, MS Livingstone Ogwo Joseph Deepak Kallubundi, BDS Matt Kepple, BPharm, MBA Naveed Ahmed Khaja Mohammed, MS W G C Kraan, MSc Griselda Loza Diaz Mary Lundberg, BS Jamye R. Mart, BS Roselyne Bosibori Matoke Tamara Maxwell Elizabeth May |
Susan McCachren, ACDPM Andrew George McFarlane Eric Melnychuk, BA, EMT, CCRP Patricia Moracco, BGS Deepa Muralidharan, MSc Dori Ann Naerbo Virginia Ngan, BS Ezekiel Ragira Oenga Precia Oh Tolu Yetunde Onuwe Dynel Oxendine, ACDPM Ajay Parker, BHMS Rita Pavone, MA Traci L. Peddie, CCDM, BA Binitha Prasad Shylaja Prasad, MS Rosemary Rohrman Donald Salami Robert Schiff, BS, MS, PhD Baha Shabaneh Anton Evgenjevitch Shchepetov Stefan P. Shipman, BA Michelle Simms Barry M. Springer, MBA Raja Lakshmi Srinivas Agnihotram, MS Kathleen St. Cyr, BSN Barbara Stallman, BS Ganene Steinhaus, BSN, CCRC, CCRA Yemisi Adunni Tayo Rachel Tham, BS Rod Thorell Sussie Tornbak, CDM Hilliary Turnipseed Kathryn Voegeli, PhD Stephanie von Mosch Lynn J. Watson Ahmed Abdel Mabood Zeeneldin |
SCDM congratulates the following members for entering
their 5th year of membership in January 2010!
|
Luanne M. Bartholomew Alessandro Bestetti, PhD Brian Bottema, BS, CCDM Adam Colley, BS Sierra Fourwinds Pascal Groenen, PhD Srivatsa J. Gundala Susan Jefferson, CCDM Deborah A. Lenhart |
Marc Levine Dirk Lindner, MS Kavita Mareddy, BS Aisyah Misbari Olivia Montano-Tritz, CCDM Ngoc Nguyen, BS Don Pardy, BBA, MS Jennifer Price Bo Qing-Yan, MD |
SCDM congratulates the following member for entering
their 10th year of membership in January 2010!
Margaret Duff, BA
Hope A. Sauppe, BS, MS
Eric A. Tate
10th e-Clinical Trials
VIBpharma
May 18-19
Munich, Germany
SCDM members receive 10% off registration with code SCDM10%
The 10th Annual e-Clinical Trials Conference will bring together pharmaceutical companies to share their experiences and to present practical examples of end to end, fully integrated e-clinical trials processes.
It is the wide mix of attendees at this conference that makes it the primary event on the topic of how the whole e-clinical mix is improving the various functional areas of clinical trials and ways you can maximize your costs and time savings.
As a result of detailed research with experienced professionals involved in clinical trials throughout Europe, a wide range of critical topics will be debated at this exciting event, including:
- How to manage the evolving e-clinical trials landscape and technology
- Fast and efficient implementation of EDC
- A practical approach to the new technology and how this has affected monitoring trials
Register your place now and receive 10% off the conference fee. This event will sell out. For more information, e-mail emahnhauari@arena-international.com or call +44.207.936.6672.
SCDM Members Receive Discounted Registration to Partnerships in Clinical Trials Event
Through a partnership with the Institute for International Research, SCDM members receive 25% off the cost of registration to the 19th Annual Partnerships in Clinical Trials conference, April 12-14 at the Orlando World Center Marriott in Orlando, FL.
Register online and enter code XPSCDM to receive the discounted registration rate. Only SCDM members qualify for this special rate.
About Partnerships in Clinical Trials
Partnerships with CROs is now known as Partnerships in Clinical Trials. After almost 20 years, the industry and the event have experienced tremendous growth as outsourcing to CROs and other clinical outsourcing providers has become more than a strategy to control costs and expedite clinical trials but the strategy for ensuring value and quality in complex clinical trials. The new title better reflects the comprehensive nature of the program, which is the must-attend annual event for clinical outsourcing and development professionals, and is increasingly valuable to those with responsibilities in clinical operations, drug safety and quality. Partnerships in Clinical Trials continues to be the leading global event serving the educational and business needs of pharmaceutical, biotech and medical device executives in the United States.
Visit www.clinicaltrialpartnerships.com for more information, or read the IIR blog or follow IIR on Twitter.
