Important Announcements
SCDM Launches NEW Education Portal
SCDM has introduced the Education Portal to its website to assist clinical data managers prepare to sit for the Certified Clinical Data Manager (CCDM) exam. The Education Portal will also support Clinical Data Manager's ongoing professional development needs. SCDM has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET).
The site includes:
- A self-assessment tool to help identify areas of strength and weakness by competencies assessed in the CCDM exam;
- A list of exam competencies, along with information about exam logistics, a certification guide and an application;
- A section on coaching offers tips for forming study groups and a link to Data Matters, SCDM's Listserv;
- Study reference materials are identified and linked to the SCDM Media Store powered by Amazon.com;
- The store offers an easy way to order relevant books and other materials online; and
- Educational opportunities and resources include registration information about upcoming webinars and workshops, and archived versions of past offerings.
The site can be accessed from SCDM's homepage at www.scdm.org or directly by entering http://portal.scdm.org.
With the new web 2.0 technology stack used for this portal, content updates and new tools such as forums, online classes and collaboration tools such as blogs and wiki's will help SCDM bring a new content to our membership in new and exciting ways. With these exciting possibilities, we will need your help in the form of feedback to help us meet and exceed your needs and expectations as far as content and tools. Feel free to let us know how this offering can be improved by emailing info@scdm.org.
A second version is already underway and will be enhanced by the addition of a practice exam and the SCDM University, a repository of online courses that will address topics related to Study Startup, Study Conduct and Study Closeout.
SCDM Leadership Forum
March 17-19, 2009 Nashville Marriott at Vanderbilt University
To all leaders in the CDM discipline,
SCDM invites you to participate in the 2009 Leadership Forum. This conference is becoming the principal forum for strategic discussions of interest to SCDM professionals. Over 90% of 2008 attendees indicated they plan to attend again this year or recommend a colleague participate . Below please find an overview of the agenda; we are sure you won't want to miss this meeting. Attendance is limited to ensure a personally valuable experience, so please plan ahead. Registration is open and available on the SCDM website.
SCDM is looking for a lively discussion on the tools and information necessary for a leader to successfully guide a CDM organization through changing times. Thus, the sessions have a general business / academic expert; as well as, industry expert leading each topic. The sessions are also divided into a primer at the onset, then a structured discussion deeply penetrating the selected topics, and finally smaller groups applying their knowledge in an interactive setting. The opportunity to reconnect with colleagues and leverage the knowledge of this group to refine your perspectives and strategy is an earmark of the Leadership Forum. We look forward to seeing you in Nashville.
Strategic Leadership in a Changing Environment
Keynote Presentations
The global business of clinical research is conducted within the complex environments of scientific discovery, healthcare information technology and regulatory oversight. Successful organizations may be measured by a variety of performance indicators, yet those often poorly capture an organizations capacity to sustain success or meet future needs. Effective strategic leadership results in organizational capacity to sustain success while routinely handling the environmental and operational challenges it is presented. Our keynote presenters will provide guidance on strategic leadership as well as navigating through change in the healthcare industry and CDM specifically.
The evening session will also include a report from the Society for Clinical Data Management's role supporting the FDA work to modernize clinical trials and the Clinical Trials Transformation Initiative (CTTI).
Risk Management
Organizations invest enormous resources ensuring decisions are based on sound information. Do you (and your staff) understand and make appropriate evaluations of risk as part of the routine decision making process? Organizational leaders are accountable for the risks associated with conducting clinical research and there is significant opportunity for CDM to greatly contribute to the overall risk management strategy. This session will highlight the risks as seen by our stakeholders and discuss methods to manage risk through the use of the clinical data resources available to us on every project.
Business Partnerships
Organizations rarely have the capacity to independently support all requirements that need to be fulfilled to conduct clinical research. Relationships with other organizations can provide expertise, resources or flexibility in meeting your scientific and business objectives. Whether this takes the shape of a preferred local staffing agency, a technology vendor, or globally outsourcing your operations the macroeconomic factors are only one angle. Focus will be placed on understanding your organizational business strategy from a CDM perspective and approaches to successfully building relationships with other organizations. Case examples will include both single point solutions and those that change the shape of an entire organization.
Organizational Leadership
Leadership and management are often used interchangeably, both in informal discussion and in governance models. The field of clinical data management and the requirements of scientific research are increasingly reliant on leadership in our field; however, this opportunity must be met by effectively filling those needs within an organization and developing future leaders from within the domain. In this changing environment effective leadership will need to hold a broader set of knowledge than expected of our management roles, including the forming effective work environments, understanding models of organizational behavior, job satisfaction factors, effective approaches to role definition and governance, staff development, and developing operational services that meet the needs of our stakeholders. This session will discuss how leaders can effectively ensure their business is designed for success.
Register for the SCDM 2009 Leadership Forum:
https://www.scdm.org/events/leadership2009/registration.asp
Interesting in sponsoring an event at the 2009 Leadership Forum?
Click the link below for more sponsorship information:
https://www.scdm.org/events/leadership2009/sponsorship_reg.aspx
CCDM Industry Rewards Program
SCDM wants to reward your organization's commitment to hiring
Certified Clinical Data Managers!
As an organization that hires Clinical Data Managers, you know the added value that a Certified Clinical Data Manager (CCDM) brings. Through stringent testing, SCDM's certification program helps you identify exceptional talent in the CDM industry.
With the introduction of the CCDM Industry Rewards Program, SCDM will reward your commitment to excellence by recognizing the level of CCDMs in your organization. The best part is you can increase the benefits to your organization by increasing the percentage of CCDMs that you employ.
Here's how
SCDM will recognize you at the level you are at now and assign you rewards you can use in 2009. You can increase your rewards by encouraging certification of your CDMs or hiring CCDMs.
Reward levels are as follows:
- CCDM Industry Partner 10% of CDM employees have passed the CCDM examination
- CCDM Industry Leader 25% of CDM employees have passed the CCDM examination
- CCDM Industry Champion 50% of CDM employees have passed the CCDM examination
- CCDM Industry Master 100% of CDM employees have passed the CCDM examination
*The percentages are based on regular employees of an organization, contractors can not be counted.
Rewards:
CCDM Industry Partner
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference.
- Recognition during the annual conference business meeting.
CCDM Industry Leader
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- Recognition during the annual conference business meeting.
- A certificate will be provided to the organization recognizing their level at the annual conference
- One FREE certification exam for a non-certified CDM
- One FREE individual webinar registration
CCDM Industry Champion
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference
- Recognition during the annual conference business meeting
- One FREE certification exam for a non-certified CDM
- One FREE individual webinar registration
- One FREE Job Posting on the SCDM website
- One FREE banner advertisement (for one month) in Data Connections
CCDM Industry Master
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference
- Recognition during the annual conference business meeting
- One FREE certification exam for a non-certified CDM
- Two FREE individual webinar registration
- One FREE Job Posting on the SCDM website (for a total of two)
- One FREE six month banner advertisement in Data Connections
- One FREE half page ad in the annual conference program
Are you ready to renew your SCDM Membership?
2009 is going to be a great year for SCDM.
Your membership will expire on 12/31/2008, and you don’t want to miss a thing.
As a member of SCDM you will receive:
- Good Clinical Data Management Practice document (GCDMP).
- Unlimited downloads of the full GCDMP.
- Unlimited downloads of individual chapters (creating new chapters and making updates are ongoing).
- Unlimited access to chapter podcasts.
- Resources for Certification preparation and Professional Development
- NEW Education Portal.
- Data Basics (SCDM’s quarterly printed newsletter).
- Data Connections (SCDM’s monthly electronic newsletter).
- Unlimited access to SCDM’s on-line Membership Directory.
- Discounts on SCDM educational offerings including:
- 2009 Leadership Forum.
- 2009 Webinar Series-Topics coming soon.
- 2009 Annual Conference.
- and much more...
Educational Opportunities
2008 Webinars Available on SCDM WebsiteIf you missed one or several of the popular and highly rated SCDM sponsored webinars this year, you're in luck. You'll find them archived on the SCDM website and available for viewing. You can even earn CEU's toward recertification if you are already a CCDM by successfully completing the brief multiple choice quiz that accompanies each webinar.
These webinars consistently received high marks by attendees for professionalism, length and satisfying the expectations of viewers, with the majority of ratings at or above 90%. Here's a quick review of the past four offerings. For a more detailed description, go to the SCDM website at http://www.scdm.org/events/webinars/archive
Coding (offered 11/8/07 & 12/6/07)
This series of two webinars addresses Coding Conventions and Best Practices, as well as Coding Dictionaries: a Look at MedDRA and WHO Drug is aimed at a cross-section of Clinical Trial and Data Management professionals including: CDMs, Biostatisticians, Clinical Scientists, Coding Specialists and Drug Safety Representatives.
Introduction to CDASH (offered 4/10/08 & 4/17/08)
Webinar #1 focuses on the basic data collection fields for CDASH Packages 1 and 2 (Adverse Events, Concomitant Medication, Demographics and Subject Characteristics, Inclusion/Exclusion Criteria, Medical History, Substance Use, Physical Exam and vital Signs). Webinar #2 focuses on the basic data collection fields for CDASH packages 3 and 4 (Drug Accountability, Exposure, Comments, Protocol Deviations, Disposition, Lab and ECG). Both conclude with a presentation on the practical implementation of CDASH recommendations and are aimed at a cross-section of Clinical Trial and Data Management professionals interested in obtaining a better understanding of CDASH.
Data Quality (offered 6/5/08 & 6/19/08)
This series addresses aligning DQ practices with Critical Path risk-based philosophies, and new approaches for DM to measure and control DQ, including statistical process control and trend analyses. The first webinar specifically covers best practices for defining and measuring data quality, while the second webinar is an advanced approach to DQ including data cleaning using trend recognition and statistical process control. Both programs are directed to data managers, managers of data groups, quality control and quality assurance statisticians, and project managers with higher experience levels.
Data Acquisitions - Introduction to Data Collection and Data Management Practices in Cancer Research (offered 7/23/08)
This webinar provides an introduction to data collection and data management practices with a focus on cancer research for Data Managers, Project Managers and other project team members working with cancer research data. Featured speaker is Liz Ness, director of staff development at the National Cancer Institute's Center for Cancer Research.
To access any of the series listed here, go to
http://www.scdm.org/events/webinars/archive/
"DataMatters" Listserv Grows in Popularity
The SCDM listserv "DataMatters" is an online dialogue among members and others with common interests and experience in clinical data management. Through the listserv, discussions form around ongoing, focused CDM concerns, with individual subscribers contributing or listening in on news, policies, practices, questions and solutions. Listservs are driven by member interest and energy. They are self-subscribed and are open to both members and non-members to encourage a wide involvement of interested professionals.
The number of subscribers continues to grow. To subscribe, please follow the link below and complete the form under "Subscribing to DataMatters". You will then receive a confirmation email with instructions to complete the confirmation process. Upon approval from SCDM staff, you will then become a member of the Listserv.
http://www.scdm.org/datamatters
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.
SCDM Classifieds
Advertising Opportunities
Would you like to see your Company Ad and Logo in Data Connections or Data Basics? Schedule your ad before the end of this year to guarantee 2008 pricing! Contact Sue Abrahms at (414) 226-0362 - sabrahms@scdm.org for more information!
In Other News
SCDM October Board of Trustees Update
It's hard to believe the Holiday Season is again upon us. Next week, I'll be joining my family in Indianapolis, where I'm looking forward to my Mom's very special take on pumpkin pie!
Since this month has been a bit quiet on the Board of Trustees front, I thought I would take the opportunity to reflect on my BoT experience, since next month will be my last as an official Trustee of the Board.
I still remember my very first BoT meeting during the annual Fall Conference in San Diego in October of 2005. Since I was just voted in as Trustee, I was invited to join the BoT meeting as an observer. Because I was just there to observe, I think I only opened my mouth once or twice during the entire meeting. The other BoT members must have been thinking, "What hole did this guy crawl out of?" Quite honestly, I was a nervous wreck, wondering what I'd gotten myself into.
After the meeting concluded a wonderful thing happened. Fellow BoT members Jane Hiatt, Jonathan Andrus and Anthony Costello invited me to join them for a meal…that's where they filled me in that it was not only okay, but expected for me to pipe up in the BoT meetings. For those of you who attended the Fall Conference in Dallas, you can attest to the fact that I have not shut up since!
I've seen some really terrific things happen with SCDM in my 3 year tenure on the board. Some of our accomplishments for which I am most proud include:
- Our significant increase in educational offerings, and the formation of an Educational Committee, complete with SCDM staff to support it
- Winning the 2007 GCPj Award for the Most Successful Company or Program of the Year in Raising GCP Standards for the GCDMP Document
- The continued growth in our membership and attendance at both the Leadership Forum and Fall Conferences
- Launching the 2nd Version of the CCDM exam in 2008, well ahead of schedule
- The significant increase in the number of newly certified CCDMs in 2008
- The expansion of both our services and membership internationally, as well as our growing alignment with other global CDM organizations
- Finally, working with an exceptionally talented team of fellow Trustees and staff members of SCDM…they have made this experience one of the biggest highlights of my career.
There's never been a better time to get involved in your Society…we have even greater things planned for the coming year. Even though I will official retire my Board seat, you can bet that I will continue to be an active supporter and participant in my Society. I encourage all of you to do the same!
Have a terrific Thanksgiving holiday!!!
Derek
Getting to Know the CCDM
SCDM is proud to introduce Elisabet Hoffman as a recent recipient of the Certified Clinical Data Manager (CCDM) designation. Elizabet is a Clinical Data Coordinator II with MedImmune in Gaithersburg, MD.
- Why did you become certified?
I became certified so that I would learn how to be a better data manager. The certification exam provided a good incentive to force myself to study and learn the GCDMPs. With all the pressures of work, it was hard to motivate myself to really study the GCPs, but with the incentive of a reward, in this case certification, I took the extra time needed to study. - What challenges did you have taking and studying for the exam?
My main challenge was finding the time to study. - How has being certified benefited you?
Studying for the exam helped me understand the GCPs better and to see where I could improve in using these in daily tasks. I found that I was more efficient in my work and understood the processes better. The process of certification has made me a better data manager. - What materials did you use to study for the exam?
I studied the GCDMP manual published by SCDM, online courses of Medical Terminology by Corexcel and GCP online courses by Compliance Wire. While taking the exam, daily work experience really helped me answer the questions, in combination with knowledge gained from the study materials. - Any additional comments you would like to provide? The exam was much more 'user friendly' than the previous practice test questions.