IMPORTANT ANNOUNCEMENTS

Registration is Now Open!

The 14th Annual Fall Conference for the Society for Clinical Data Management (SCDM) will be held in Dallas, Texas from Sunday, September 21 through Wednesday, September 24 at the Hyatt Regency Dallas. A dedicated and hard working 2008 Fall Conference Committee created a program targeted toward individuals in the discipline of Clinical Data Management. You can now find detailed conference information at http://www.scdm.org/events/fall2008/.

REGISTER NOW!
Members: $800.00
Nonmembers: $1000.00
To register visit online visit https://www.scdm.org/events/fall2008/registration.asp

SCDM Becomes IACET CEU Provider

SCDM has been selected by the International Association for Continuing Education and Training (IACET) to award IACET Continuing Education Credits for all current educational programs that meet the IACET standards.

SCDM underwent a rigorous application and audit process to become an Authorized Provider (AP) of IACET Continuing Education Credits. SCDM's continuing education values and goals, program outcomes, infrastructure, customer support, and member needs assessment procedures were scrutinized by IACET to ensure adherence to the IACET ANSI Standard for Continuing Education and Training.

The International Association for Continuing Education and Training (IACET) is a non-profit association dedicated to quality continuing education and training programs. IACET certifies selected providers that meet strict continuing education guidelines. IACET guidelines are based on deep understanding of the learning process. IACET is recognized as the leading standard-setting organization for continuing education and training providers.

"This credential is a testament to the quality products and services SCDM offers members and the clinical data management profession," says Jonathan Andrus, CCDM, and Chair of the Board of Trustees of SCDM. "This could not have been accomplished without the excellent work of the education committee and staff. This recognition is yet another indicator of the quality of our educational offerings."

2008 Webinars Available on SCDM Website

If 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 (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/

EDUCATIONAL OPPORTUNITIES

Environmental Scan Sub-committee

GOT TRAINING? LET US KNOW
SCDM is conducting an environmental scan of sources that offer in-house CDM training including professional associations, academic institutions and for-profit training companies to ascertain the extent of programs available. SCDM's interest is in collaborating with outside sources to create an online curriculum aimed at preparing clinical data managers for the certification exam as well as a means to updating their skills for career advancement.

If your organization offers courses, workshops, tutorials or intensives that address CDM competencies - in whole or in part - please take this brief survey by clicking the link to advise us of the kind of education programs your company offers. This is exploratory only to see where there may be gaps as well as ample resources. It will help SCDM become aware of potential partnerships within the clinical data management community that could be fruitful. All responders will be entered into a drawing for a chance to win a $50 Amazon gift card. For questions or comments, please contact Sharon Kayne Chaplock at schaplock@scdm.org.

Call for Articles Data Basics

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 more information.

"DataMatters" Listserv

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

SCDM CLASSIFIEDS

SME's 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 (SME's) to work on the Data Entry/Data Processing and Data Storage chapters. 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 30-40 hours over the course of the assignment.

Work will continue until chapters are complete - for approximately 2-3 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 via e-mail schaplock@scdm.org

IN OTHER NEWS

SCDM August Board of Trustees Update

by: Derek Perrin

Well, its mid-August, which means my Annual Conference presentation, is due (or in my case, overdue) and summer is drawing to a close. Surprisingly, the evenings have already begun to get that crisp Fall feel …it always comes too soon!

Speaking of the Fall, we are one month away from our Annual Conference in Dallas. The exhibit hall is sold out, the speakers are polishing their presentations, and the fun at Texas stadium is about to begin. The only thing missing is you!

If you have not registered for SCDM's Annual Conference, there is still time; however be sure to register soon. The response to this conference has been so great that our headquarter hotel; the Hyatt Regency, is sold out. SCDM has secured rooms at two historic Dallas locations. Check out the SCDM Annual Conference link for details on "where to stay" and "how to register".

The excitement within SCDM just keeps on going with the announcement that SCDM has received the International Association for Continuing Education and Training (IACET) approval to award IACET continuing education credits for all educational programs that meet IACET standards. This is a significant accomplishment for the Society, and I would like to thank both Sharon Kayne Chaplock and Sue Abrahms of SCDM's Education department, for their efforts in making this happen!

Additionally exciting was our most recent board meeting in Milwaukee, WI earlier this month, where we were greeted by our dedicated staff with a champagne reception to celebrate our numerous 2008 accomplishments. I have mentioned these accomplishments in other updates but just to recap:

• Successful completion of the certification exam updating process, the final exam will launch in September
• Successful completion of the GCDMP EDC chapters which are scheduled to be released this Fall
• Successful implementation of the new GCDMP chapter writing process
• Successful completion of five educational webinars on CDASH, Data Quality and Data Acquisitions.
• …there are so many more but these are just a few of our 2008 accomplishments.

In addition the Board meeting gave us an opportunity to renew our roles as Board members of the Society and better understand "Strategic Thinking and the Will to Govern Well". Facilitated by Kermit Eide of Tecker Consultants, this board meeting opened our minds to rejuvenate the strategic thinking process we all must follow as board members. I found this meeting particularly useful as we focused much of our energy on thinking into the future. In addition, we created a plan to orient our new board members into the strategic processes of a Board, with an emphasis on innovation and creative thinking. My personal contribution will be to mentor our new board members to the ins and outs of the SCDM Board experience so that they can enjoy and engage themselves as soon as their term begins.

Lastly, the Board approved the slate of candidates for the 2009 Board of Trustee elections. Watch your e-mails and cast your ballot soon.

Have a terrific rest of your summer; I look forward to meeting many of you in Dallas.

Derek Perrin, CCDM

SCDM Committee Updates

The Fall Conference Committee is finalizing content for this year's conference, September 21st to 24th in Dallas, TX. Some of the activities in progress:

Sessions:
Our session chairs have coordinated with their speakers to get presentations developed, reviewed, and finalized. Learning objectives have been finalized as part of our IACET requirements for CEUs. You'll see these objectives and some questions about each session in the materials provided at the conference.

Steve Wilson and several FDA staff members will kickoff this year's FDA session with presentations and discussion of areas important to SCDM members. Thanks to our members who responded to our topic survey earlier this year. This session is slated to be a part of all future SCDM Fall Conferences.

Exhibitors: Our exhibition hall is completely sold out thanks to the efforts of SCDM's administrative staff. Special thanks to Aaron Miller and Margaret Trotter for contacting vendors and ushering them through the vendor selection process. Special thanks to our exhibitors for their continued support of SCDM and its members.

Sponsors: Sponsorship is at record levels! There are a few sponsorship opportunities remaining if anyone is interested. Please contact Margaret Trotter at SCDM for details.

If you would like to be a part of next year's fall conference committee, please contact Margaret Trotter at mtrotter@scdm.org and she'll forward the information to our co-chairs for next year's meeting.

The Marketing committee is expanding!

As the SCDM continues to grow, volunteers are needed to join the Marketing Committee. If you are interested in helping market SCDM, our activities and services to our members and the world, please volunteer by contacting info@scdm.org

Getting to Know the CCDM

SCDM is proud to introduce Cynthia Baxter as a recent recipient of the Certified Clinical Data Manager (CCDM) designation. Cynthia is a Data Manager with Metagenics, Inc. in Gig Harbor, WA.

1. Why did you become certified?
   • The reason is two-fold - (1) To add additional gravitas to our research and clinical prowess and (2) to boost my status as a validated team member
2. What challenges did you have taking and studying for the exam?
   • Taking the exam wasn't much of a challenge - the testing center was actually located down the street from where I live - how lucky is that? I scheduled to take the test during my vacation so that I would be rested (and could cram!) and not stressed out.
   • Studying for the exam presented some interesting challenges because I re-read the entire GCPDM manual amongst others and my mind kept wanting to skip over familiar material. So it was a constant struggle to stay engaged with the reading. Luckily I have a great supervisor who allowed me to "work from home" so that I could get large tracts of reading done.
3. How has being certified benefitted you?
   • Since I am newly certified, the benefits are still coming - but already I am recognized at work as an "official" on data. It's funny how these work - but it's so true. I'm the same person now as I was last week - I just have letters after my name now - but suddenly that makes all the difference.
4. What materials did you use to study for the exam?
   • I went "all out" - I had read in other interviews like this that the GCPDM was vital. I agree wholeheartedly! I also got a hold of a Barnett Data Management course handout and read that, the GCP newsletters from Thompson Publishing, and being on every LISTSERV (Forum) I could find for CDM - including CDISC
5. Can you provide helpful hints for those interested in taking the certification exam?
   • Colleagues in the industry are excellent resources - your company may be doing it one way, someone else has a different approach - learning this provides you're a larger scope and prepares you better in answering questions that require application skills. Having said that, sit on some forums and observe the conversations - even post a question or two. Everyone is friendly and wants to help. An excellent Forum is located at the CDISC website.
   • Read everything
   • Relax and trust in the work you have already done!
6. Any additional comments you would like to provide?
   • It would be nice to receive feedback after the certification on what domains errors occurred. Unless you received a 100% - you answered some questions wrong - I personally would like to go back and strengthen my weak points.

SCDM Welcomed these NEW Members in July 2008!

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

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