Important Announcements

2009 Webinar Schedule Announced! Registration Now Open

Invitation: Prepare for challenges facing CDM leaders

2009 SCDM Leadership Forum
March 15-17
Vanderbilt University
Nashville, TN

• Keynote speaker Congressman Jim Cooper (D-Nashville) Healthcare policy adviser to the Obama presidential campaign, offers an insider's look at healthcare policy trends and challenges
• Tom Moreno, U.S. Food and Drug Administration, heads a discussion on developing and applying risk management methods

The SCDM Leadership Forum is the premier forum for strategic discussions surrounding clinical data management. The three-day conference specifically targets CDM executives and other industry leaders, and encourages the leverage of collective knowledge and experience. The Forum prepares leaders to improve productivity and guide their organizations through today's rapidly changing global CDM environment.

Other session topics include trends in CDM, strategic business partnerships and leadership development.

Registration is limited is limited to 70 participants with many attendees returning from last year. Reserve your space today.

REGISTER NOW!

Visit www.scdm.org for complete Leadership Forum details, including a schedule of events.

SCDM RELEASES DATA MANAGEMENT PLAN CHAPTER FOR THE GCDMP

The Society for Clinical Data Management released the newest addition to its Good Clinical Data Management Practices (GCDMP) document with the publication of the Data Management Plan chapter in December. Charlene Dark, co-chair of the GCDMP Committee, commented that "In our continued commitment to advancing the profession of clinical data management, SCDM's GCDMP Committee is very excited about the publication of the Data Management Plan chapter. This chapter is the first set of documented best practices in developing a data management plan. We believe that we have compiled a sound guidance for data managers, and we have made great strides in the direction of more standardized practices when developing and maintaining a data management plan. We are very proud of this accomplishment."

The Data Management Plan chapter is available to members through the Society's Web site. Non-members are able to access the entire updated document for a fee. A podcast version of this newest chapter is in production and scheduled for release in the first quarter of 2009.

SCDM would like to recognize and thank all subject matter experts who contributed to the development of the Data Management Plan chapter, including Michele Goldstein (University of Rochester), Laura Fazio (DePuy Orthopaedics, Inc.), Reza Rostami (DCRI), Denise Redkar-Brown (Cetero), Joseph Pascua (Genentech, Inc.), Pam Harvey (American College of Radiology) and Mary Baldovsky (PharmaNet). Further, the chapter benefited from extensive peer review by the entire GCDMP Committee, SCDM's Board of Trustees and an international review from selected members of INCDMA. To learn more and to access the chapter, visit www.scdm.org.

SCDM Discussion Forum to Close March 1
Join the "DataMatters" Listserv - 170 Members Strong and Growing!

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 to 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.

To subscribe, please follow the link below and complete the form under "Subscribing to DataMatters." You will then receive a confirmation e-mail with instructions to complete the confirmation process. Upon approval from SCDM staff, you will be added to the Listserv.

Subscribe now and see what we're talking about!

http://www.scdm.org/datamatters

GCDMP Contributors Recognition

SCDM wishes to thank the following people for contributing their time and talent to creating or revising chapters in the GCDMP during 2008. Their dedication and expertise are vital to sustaining the timeliness of the GCDMP and the professionalism of clinical data managers.

New Chapters:

• EDC Startup: Jonathan Andrus, CCDM; Paul Clarkson, CCDM; Ralph Russo, CCDM; Teri Hicks; Deb Jendrasek; Marco Vandoeveren
• EDC Conduct: Jonathan Andrus, CCDM; Paul Clarkson, CCDM; Ralph Russo, CCDM; Teri Hicks; Deb Jendrasek; Marco Vandoeveren
• EDC Closeout: Jonathan Andrus, CCDM; Paul Clarkson, CCDM; Ralph Russo, CCDM; Teri Hicks; Deb Jendrasek; Marco Vandoeveren
• Data Management Plans: Michele Goldstein; Laura Fazio, CCDM; Reza Rostami, CCDM; Denise Redkar-Brown; Joseph Pascua, CCDM; Pamela Harvey; Mary Baldovsky

Revised Chapters:

• SAE Data Reconciliation: Lisa Taylor, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aranmolate; Mary Callon; Colleen Cox, CCDM; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Mary Mattes; Kerry Murmello; Terri Pennell
• Measuring Data Quality: Lisa Taylor, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aranmolate; Mary Callon; Colleen Cox, CCDM; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Mary Mattes; Kerry Murmello; Terri Pennell
• CRF Completion Guidelines: Vesna Zovkic, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aramolate; Mary Callon; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Mary Mattes; Kerry Murmello; Terri Pennell
• Clinical Data Archiving: Colleen Cox, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aranmolate; Mary Callon; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Vesna Zovkic, CCDM; Mary Mattes; Kerry Murmello; Terri Pennell
• Vendor Management: Bernadette Farrell, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aranmolate; Mary Callon; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Vesna Zovkic, CCDM; Mary Mattes; Kerry Murmello; Terri Pennell
• CDM Presentation at Investigator Meetings: Bernadette Farrell, CCDM; Susan Howard; Linda Mathias; Teresa Ancukiewicz, CCDM; Yetunde Aranmolate; Mary Callon; Karen Hicks, CCDM; Nicole Gallegos; Theresa Perry; Vesna Zovkic, CCDM; Mary Mattes; Kerry Murmello; Terri Pennell

SCDM Presents to the FDA

Linda Talley and Ralph Russo, CCDM, our current Chair and Vice Chair, recently presented SCDM's perspectives on data quality at the FDA HSP/BIMO council meeting. The meeting gave SCDM an opportunity to present statistical methods for reducing the amount of Source Document Verification necessary while still maintaining data quality. In addition, a high level presentation on the mission and goals of SCDM was given to all gathered. We were able to showcase the GCDMP and the vital role this document plays in setting standards for data management and overall data quality for organizations throughout the world. The Board is continuing to expand the relationship SCDM has with the FDA and other regulatory agencies.

Vote Now for SCDM Bylaws Amendments

The SCDM Board of Trustees recently reviewed the Society Bylaws and approved a slate of changes to clarify and improve governance policies.

Before taking effect, these changes must be ratified by SCDM membership. All current members will receive an official announcement via mail shortly. However, you may follow the link below to vote online now.

There are 13 proposed changes to the Bylaws. Topics addressed include:

• Membership eligibility
• Trustee terms of office
• Nomination and duties of Board of Trustees officers
• Committee structure
• Corrections to grammar and organization

The ballot is designed so that current Bylaws text and the proposed amendments can be easily compared. Voting is expected to take 15-30 minutes.

All SCDM members are eligible to vote. To cast your vote, follow the link below or visit the Members Only section of the SCDM Web site.

Vote Now!

Votes must be received by March 4.

You will need your SCDM member login information to access the ballot. If you need your login information or have additional questions, please contact info@scdm.org.

Educational Opportunities

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.

2009 Annual Conference Update
October 4-7
Westin Seattle - Seattle, WA

The 2009 Annual Conference Call for Abstracts is NOW AVAILABLE ONLINE!

The Annual Conference Committee is soliciting abstracts for possible presentations for the 2009 Annual Conference. Please submit abstracts on topics that match your interest and expertise.

For a complete listing of suggested topics, including information on how to submit an abstract, please follow the link below: http://scdm.org/events/fall2009/callforabs.asp

If you have further questions, please contact SCDM at info@scdm.org or call 414.226.0362.

SCDM Classifieds

SMEs Wanted

WANTED!-Short Term SCDM-GCDMP Volunteers:
Subject Matter Experts to review the next Good Clinical Data Management Practices document (GCDMP) chapters scheduled for revision.

SCDM is looking for 3-5 Subject Matter Experts (SMEs) to work on the following chapters: Edit Check Design Principles; Project Management for the Data Manager; Database Closure; Metrics for Clinical Trials; Systems Validation/Systems Auditing; External Data Transfers.

Requirements for SMEs 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 in the first quarter of the year and continue until chapters are complete - for approximately two to three months.

If you are interested in becoming a Subject Matter Expert for any one of these chapters please send your qualifications along with a CV and the chapter(s) you are interested in to Sharon Kayne Chaplock at schaplock@scdm.org

Volunteer Speakers Bureau Forming

SCDM is starting 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! Presenters 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 presentations you've made to info@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 and/or attain the CCDM® credential. The SCDM Board of Trustees has identified the development of customized programs and products which focus on both technical and project management skills and abilities 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 - for approximately two to three months.

If you are interested in becoming a Content Specialist for any one of these courses please send your qualifications along with a CV and the course(s) you are interested in to Sharon Kayne Chaplock at schaplock@scdm.org

Have you Formed a Study Group to Prepare for the CCDM® Exam?

Share your knowledge of best practices
Let us know your group is meeting

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 (http://portal.scdm.org) 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 Web page 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.

Please e-mail Sharon Kayne Chaplock at schaplock@scdm.org to respond.

In Other News

Board of Trustees Update

In 2008, SCDM leaders and staff continued to work on your behalf to establish SCDM as the premier professional membership organization for clinical data managers and related professionals.

Here's a brief look at some of our many accomplishments:

Building membership

• Surpassed 2008 goal for new members
  • 897 new members, for a total of 2,613 - the highest in SCDMs history
• Implemented and reviewed results from a "non-renewal" survey
  • 672 respondents; resulted in 80 additional renewals
• Instituted a membership database analysis

Promoting certification

• Completed a new version of the CCDM® exam
• Surpassed 2008 goal for new CCDMs®
  • 242 new certificants, for a total of 346
• Developed and implemented the CCDM® Industry Rewards Program
  • nine companies participating
• Created and distributed a new certification brochure and sponsorship prospectus

Expanding education and professional development

• Attained IACET authorized provider status
• Launched the Education Portal, including:
  • Certification resources
  • Professional development opportunities
  • Exam prep resources
  • E-store (powered by Amazon.com)
• Four new GCDMP chapters were created and six others were revised

Improving governance, marketing and events

• SCDM infrastructure streamlined with restructuring of BoT committees
• Reduction of BoT meetings and a move to a more strategic governance approach
• Created an international presence on the SCDM BoT
• Created new logos for the GCDMP, CCDM®, CCDM® Industry Recognition Rewards and Education Portal
• Offered the first workshop on preparing for the CCDM® exam at the Annual Conference
• Presented FDA/SCDM summit at the Annual Conference

These accomplishments were possible thanks to the hard work and dedication of our many volunteers, members and certificants. Thank you for your involvement in SCDM. We are already working hard toward our goals for 2009!

Committee Updates: Annual Conference Committee Moves Ahead

The 2008 Annual Conference Committee staged another very successful conference in Dallas this year. New for 2008 were open-dialogue style sessions that generated a lot of discussion - almost all who attended the CRA/CRC session joined in the conversation of what works and what can be improved in the relationship between the data manager, monitor, and site coordinator. In addition, we had the opportunity to hear directly from the FDA on emerging issues that we face as data managers.

Our keynote speaker, David Cottrell, charged up the attendees with his opening presentation on leadership. The committee reviewed dozens of potential keynote candidates before unanimously deciding to invite Mr. Cottrell. We were fortunate to be able to book such a world-class speaker for the conference. Many enjoyed meeting Mr. Cottrell personally and purchasing signed copies of his best-selling books.

Our Data Driven Award competition showcased novel solutions being offered by several of our vendors, in collaboration with sponsor companies. Three exciting solutions were chosen as finalists for the competition. Our judges selected Arrowhead Electronic Healthcare as the winner of the SCDM Data Driven Award for their 'dumb monkey' solution for automating complex testing of eDiary devices in multiple languages. Congratulations, Arrowhead!

The award reception at Dallas Stadium was a night to remember. The food, drink and activities had everyone pumped-up. It was a unique opportunity to see this stadium up close before it is demolished this year.

Your 2009 Annual Conference Committee kicked-off planning for the 2009 Annual Conference in November. Our first deliverable was the Call for Abstracts which was issued electronically last month. From the extensive list of abstract categories (56 in all!) you can see that the Committee is full of ideas and working diligently to ensure the Annual Conference meets the needs and expectations of our membership and continues to build on the successes of past conferences. In these coming months we will continue with our planning, e.g., working to identify a keynote speaker and conference tutorials, addressing conference logistics, marketing for the Data Driven Award, supporting efforts to secure sponsorships and exhibitors, reviewing submitted abstracts and determining the actual sessions and delivering the final program. It's a lot of work but the Committee is up to and enjoying all the challenges! Seattle is proving to be a very exciting location for this conference. A trip by Margaret Trotter, our SCDM meeting planner, to scout out the Seattle Westin and potential locations for our Data Driven Award Reception was very successful. We are just beginning to work through all the meeting logistics but from Margaret's visit we know the Seattle Westin is going to be able to accommodate the needs of our conference very well. In regards to the venue for the Data Driven Award reception, there were some very exciting ideas brought to us for consideration. When the debating was completed the choice was clear. We are very excited to report to you that the Data Driven Award reception will be held at the Experience Music Project and Science Fiction Museum. If you would like to have more information regarding this location please visit the Web site, www.empsfm.org

Get to Know the CCDM®

SCDM is proud to introduce Daniel Stover as a recent recipient of the Certified Clinical Data Manager (CCDM®) designation. Daniel is a Research Data Coordinator with Hoosier Oncology Group, Inc., in Indianapolis, IN.

1. Why did you become certified?
For me it was a personal goal. The field of data management has been a good career fit for me, so having the certification tells me I'm on the right path to understanding my chosen career. It also will serve as a good foundation upon which I can build to increase my knowledge and understanding of data management.

2. What challenge did you have taking and studying for the exam?
The biggest challenge, being a father of four, was making the time to study, especially as it all had to be done on my own time. Another challenge was differentiating best practice in a situation versus the way any given company would handle it.

3. How has being certified benefited you?
The benefit of being certified, at this point, is the satisfaction of fulfilling my personal goal. Looking ahead, I see it as a stepping stone in my career development and advancement.

4. What materials did you use to study for the exam?
Mainly the GCDMP document. Prior experience also played a role when it came to applying best practices.

5. Can you provide helpful hints for those interested in taking the certification exam?
One will definitely want to review the GCDMP document. For those data management areas in which one is not strong, seek out colleagues who have that experience and glean some understanding from them.

SCDM welcomed these NEW members in December 2008!

SCDM congratulates the following members for entering their 5th year of membership in December 2008!

SCDM congratulates the following members for entering their 10th year of membership in December 2008!

CDM Outsourcing

Outsourcing clinical data management...$$$$
Outsourcing clinical data management with change orders...$$$$$$$
Sharing best practices and tools between sponsors and outsourced partners to agree on deliverables and minimize change orders…priceless.

The Data Management Outsourcing Focus Group is an industry-wide (pharmaceutical, medical device, CROs, FSPs) group centered on developing tools and sharing best practices when working with outsourced partners. If you work with outsourced partners or work in the CRO/FSP sector and have an interest in participating in the Outsourcing Focus Group , please contact Sandra Hudgens at sandra.hudgens@spcorp.com for more information.

Act Now to Ensure that Electronic Health Records
will Support Clinical Research as well as Clinical Care

Without your engagement and financial support, divergent and disparate standards
may inhibit the use of electronic health records for future research and clinical decision support.

Progress to Date
Late last year, the Department of Health and Human Services (HHS) Office of the National Coordinator of Health Information Technology requested that the American National Standards Institute (ANSI) convene a workgroup of experts in the EHR and clinical research domains. This workgroup met in November, to prioritize an initial value case for standards harmonization in this area:

Identify a common set of information that can readily be exchanged between EHRs and clinical research systems to support GLOBAL clinical research

• – Anticipated to provide a foundation for potential future use cases including:
  • Patient participation in research (subject recruitment)
  • Pharmacovigilance
  • Pharmacogenomics and biomarkers

Numerous benefits will be realized by patients, investigators, clinicians, technology and service providers, and researchers alike through the streamlining of clinical research activities.

The initial priority value case document is currently in development through HHS, with funding from several federal agencies outside of HHS and with input from the ANSI-convened EHR Clinical Research Value Case Workgroup. This document is scheduled to be finalized in March. In addition, Clinical Research was recently added to the CCHIT Roadmap for EHR Certification.

Next Steps

• Raise sufficient funds to cover organizational costs needed for the ANSI-administered Healthcare Information Technology Standards Panel (HITSP) to address the clinical research value case
• Convene a volunteer workgroup of technical experts and stakeholders in the clinical research space to work through the HITSP Interoperability Specification (IS) development process
• Produce an IS that outlines the standards, how they support clinical research and how they fit with existing HITSP IS that are already recognized for EHR use in the clinical care environment

The clinical research community must have a voice in the development of EHRs to ensure that globally-accepted clinical research standards are recognized, leveraged and included in the EHR harmonization process. But to have our voice heard, we need to help ANSI raise sufficient funds. Please ensure that you are part of this vital initiative for the future of global clinical research.

Funding needed
Contributions to ANSI to further this important work are needed and will be most appreciated, regardless of the amount given. For more information or to contribute, please contact Dr. Rebecca Kush of CDISC (512.791.7612; rkush@cdisc.org) or Frances Schrotter of ANSI (212.642.4934; fschrott@ansi.org).

Learn more at cdisc.org/publications/hitsp.html