SCDM Welcomes New Trustees

SCDM recently announced the results of Board of Trustees elections held in August.

John Estrada, Carol Garvey and Linda King will join the Board effective January 1. The three incoming Trustees attended an orientation at the SCDM Annual Conference in Seattle and listened in on Saturday's Board meeting.

Here's a brief introduction to the three new Trustees:

John Estrada
Owner and Principle Business Consultant, PGE Ventures, Inc.

Estrada has more than 12 years experience in clinical data management - including eight years at Nextrials managing EDC and e-clinical adoption and expansion. He formed his own company earlier this year.

"The next few years will be filled with continued changes and challenges," he said. "With the upcoming healthcare integration, continued globalization, continued market and economic changes and new technologies arising by the minute, SCDM will be at the forefront offering the products and services that will help our membership not only survive these changes but thrive in them. I look forward to the next few years as a member of the Board of Trustees to help SCDM lead the way during these exciting times."

Carol Garvey
Director, CDM, Genentech, Inc.

Garvey has been in the biotechnology industry for 25 years, including nearly 20 years in clinical data management at Genentech.

"I am really looking forward to working with members to set the direction for SCDM and the many professions within Clinical Data Management," she said. "I would like to see SCDM be the 'Ask Jeeves' site for our profession - the place where people go to network and get or provide guidance."

Linda King
Manager, Data Sciences and Solutions, Eli Lilly and Company

King joined Eli Lilly in 1998 after a 10-year career in transplantation laboratory medicine. At Lilly, she has led multiple data management teams and is currently manager of a global Process and Technology Lead team.

"This is an exciting time to be a data manager," she said. "The discipline continues to evolve to fit the future needs of clinical research and SCDM is in a great position to provide leadership during this time of change. I look forward to being a Board of Trustees member and helping the organization in its mission."

Leadership Transition
Additionally, beginning January 1, Ralph Russo will succeed Linda Talley as Board Chair. Talley will serve one additional year as non-voting Past Chair before rotating off the Board. Nimita Limage was elected Vice Chair for 2010; Susan Howard was elected Secretary.

SCDM wishes to thank Jonathan Andrus, Paul Clarkson, Karen Hicks and Pam Norton, whose terms expire Dec. 31. Their dedication and service is appreciated.

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 Want to Create a Study Group for the CCDM® Exam?

If you missed the free live presentation, you can view the
recording to assist you in creating a study group.

A study group can help you and your colleagues prepare for the CCDM® exam. Joshua Cox and Grant Rempe from Quintiles and Bettie Neal from PharmaNet share the secrets of their study group success during a 90-minute webinar. Josh, Grant and Bettie have helped groups prepare for the CCDM® exam and they will describe how they formed groups that were engaged, sustainable
and successful — all through creative facilitation techniques and resources that are readily available from the SCDM Web site.

Most people learn best by participating in groups that meet regularly and appeal to many learning styles.

Don't miss this opportunity to learn how you can do it too.

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 Online Learning…What's That?

Recently, we've received a number of questions related to online learning. SCDM's Director of Education, Sharon Kayne Chaplock, addresses one of them here.

Many professional development providers are coming out with "online learning" opportunities. What exactly does that term mean and what do SCDM's opportunities look like?

There are many programs being offered now under the "online learning" banner. This all-encompassing term, however, can refer to any educational offering that is supported by the Internet. Examples are courses delivered through webinars, webcasts, learning management systems and video conferencing. They are all accessed through a computer or, sometimes, even a mobile device.

SCDM has an established track record of online learning in the form of webinars, starting in 2006. This year, SCDM is going beyond the familiar 90-minute lecture/Q&A webinar sessions by adding four asynchronous online courses. The first, Data Management Plans, was offered this summer. It was hosted by Moodle, an open-source learning management system that provides a comprehensive learning experience. The response has been phenomenal, with 20 people enrolled and four on the waiting list from locations across the globe, including Russia, Kuala Lumpur, Mexico, Canada and the United States.

The asynchronous courses are interactive and instructor facilitated, offering an opportunity for a more in-depth learning experience than webinars and include real-world application of skills with peers and experts in the field of clinical data management. Learners are not required to be online at the same time and log in from anywhere at any time, allowing them to participate from their own backyards — as long as they have an Internet connection. Learners must meet deadlines for assignments, unlike self-paced programs. Course structure includes an introduction and objectives for each week's module; resources for information content, including articles, videos, Web sites or narrated slide presentations; discussion forum postings; weekly assignments; and a final project. Students in the recent DMP course completed their final project in groups using a wiki.

SCDM's online courses allow a great amount of flexibility to satisfy course requirements: the opportunity to engage with colleagues all over the world, direct virtual contact with the instructor and the ability to earn continuing education units. A byproduct that students tell us they were not expecting is developing greater proficiency with computer-based learning tools that are transferable to the workplace, like performing more productive searches, participating in collaborative work using tools like wikis and developing communication skills through the discussion forum.

SCDM's online courses are filling up fast. Don't hesitate to sign up for any of the next three being offered this fall:

• CRF Design – October 12 through November 6
• CRF Tracking and Communication – November 10 through December 4

Visit http://portal.scdm.org/online-courses for full course descriptions and registrations. Courses close after 20 enrollments. A waiting list will be started or a new course opened up should there be enough interest.

 2009 Webinar Schedule

For more information and registration, please click on the webinar title below.

Date	Title	Sequence
October 22 & 29	Patient Reported Outcomes	Career Development Sequence
November 5, 12 & 19	Project Management Toolbox	Certification Sequence

* Webinar Terms of Conditions Policy updated

Archived Webinars

• Clinical Trials Abroad
• Data Acquisition
• Data Management & Oncology Trials
• From CDASH to SDTM Data Sets - Putting CDISC Standards to Work for You!
• Overview of Emerging and Established Standards
• Trends Shaping Clinical Data Management
• Preparing for the CCDM® Exam: An Insider's View
• Study Groups 101

For more information and to purchase these webinars please click here: http://www.scdm.org/events/webinars/archive/

 Item / Question Writers Wanted

WANTED! SCDM Item Writers, Volunteers 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 Certification Test, 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 Test will begin in the first quarter of 2010 and continue until the test is ready for roll-out 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, please prepare a half-page statement of interest in which you describe the GCDMP chapter(s) or topics in 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 via e-mail schaplock@scdm.org

 SME's Wanted

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

SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Systems Validation/Systems Auditing and External Data Transfers.

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 guidance
• 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 as soon as SME's are identified and continue until chapters are complete - approximately two to three months.

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

 Companies Demonstrate Commitment to Certification

The CCDM® Industry Rewards Program is now closed for 2009. Watch for updates this fall on the 2010 program.

SCDM rewards the following companies for their commitment to excellence through their support of the CCDM® program:

Industry Master — 100% of CDMs are CCDM®s

• Cleveland Clinic Vascular Surgery Academic Coordinating Center
• McDougall Scientific Ltd.
• ClinForce LLC
• Kestrel Consultants, Inc.
• Tolerx
• Shannon Labout, CCDM

Industry Champion — 50% of CDMs are CCDM®s

• Cetero Research

Industry Leader — 25% of CDMs are CCDM®s

• Covidien
• Duke Clinical Research Institute
• Enzon Pharmaceuticals, Inc.
• Innovative Analytics
• BioClinica, Inc.
• ResearchPoint

Partner Level — 10% of CDMs are CCDM®s

• Roxaane Research Limited
• PharmaNet Development Group

 Get to Know the CCDM®

SCDM is proud to introduce Dr. Smita S. Savant, CCDM, as a recipient of the Certified Clinical Data Manager designation. Dr. Savant is an Associate in Data Analysis with Cognizant in Mumbai, India.

Q:	Why did you become certified?
A:	The certification is one of its kind. And getting certified gives me the edge over the other data mangers worldwide.
Q:	What challenges did you have taking and studying for the exam?
A:	I had to unlearn and relearn the worldwide practices. Had to keep in mind that the practice in my project may be minimum practice but need not be the best practice.
Q:	How has being certified benefited you?
A:	The recognition in the organization as well as in the CDM fraternity has increased.
Q:	What materials did you use to study for the exam?
A:	I have extensively used the GCDMP, as well as Practical Guide to Clinical Data Management by Susanne Prokscha. Also referred to the PMBOK
Q:	Can you provide helpful hints for those interested in taking the certification exam?
A:	• Unlearn what you do in your project or company. May not be the best practice. • Try to read as much as you can about different practices such as DM, DE, Programming and study    set up. • Take the mock test on the Web site. • All the options seem the best. Learn to sift through the least likely to arrive at the most appropriate    answer. • Trust your gut feeling, it could turn out to be the most correct response.

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 SCDM welcomed these NEW members in August 2009!

Rahul Alawadhi, MS Bonnie Beaver, BS Tamara Bratt, MHS Hope Bryan, MS Michael Di Marino, BA, MA Sheane Diehl Thamar Draper, BSc Deborah Lee Drosdick, CCDM, BS Valerie Espinueva Amy M. Farrell, BS, CCDM Jacob Foate, BS Donna J. Gugger Nagaraja Hegde, BCA Carol Houts, BS

Virginia Kessing, BS Madhu Kumar Komuravelli, BS Janice Kuse-Hamilton, MS Sukyoung Kwon, MPH Susy J. Laws, BSc, Hons Rebecca Mason, MPH Erin C. Matsunaga, BA Alan McLaren, BA Sreelatha Meleth, PhD, BS, MA, MS Sudhamohan Muppagouni Samantha Park, BS Deidra Poucher Ravishankar Prabhakar, MBA, BE, PMP, ITIL Tracee Robinson, MS

Kelly Rymer, BS Jasmine Saba, MS James Sabogal, BE Amy Schlesselman, BS Stephen M Sheldon, BM Linh Sites, AA Lynnsea Smith Ashok Srivastava, MD, DM, PhD, MBA Regine Turner, Med, BA Djamei Vahid, MS Neil Vivian, MSc Margaret A. Williams, BS Jennifer Willis, BS Chris Woodill, BA

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