A monthly publication of the Society for Clinical Data Management.
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 2009 SCDM Annual Conference

Top Five Reasons to Attend the SCDM Annual Conference
You won’t want to miss the 2009 SCDM Annual Conference, October 4-6 in Seattle. Here are the top five reasons to go:

  1. Variety With sessions covering Best Query Writing Practices, eClinical/eHealth Initiatives and everything in between, the SCDM Annual Conference provides the complete educational experience you’re seeking. This year’s 50+ presentations were selected from more than 225, ensuring quality and diverse sessions.
  2. Learn from Industry Experts Sessions are led by leaders in clinical data management. Representatives from the Food and Drug Administration, CDISC and the Metrics Champion Consortium will share their knowledge and insights.
  3. More Bang for Your Buck With a possible 17 hours of instruction, the SCDM Annual Conference is a tremendous value. Register by September 25 and pay only $800. For those looking for more, check out our pre-conference tutorials, half-day sessions that cover topics in-depth – choose from CDISC, coding or lab data.
  4. Networking The SCDM Annual Conference brings together more than 600 professionals in clinical data management. Our exhibit hall, networking breakfasts and evening socials offer opportunities to strengthen existing relationships or meet new contacts.
  5. Fun Your registration fee includes a ticket to the Space Needle and access to the Data Driven Innovation Award reception at the Experience Music Project, an interactive museum chronicling the history of rock-n-roll, its roots in earlier genres and its impact on popular music today.

Don’t Delay
Only four weeks remain until the 2009 SCDM Annual Conference in Seattle.

Register soon to avoid late registration penalties and ensure your choice of hotel accommodations.

This year’s meeting headquarters is the Westin Seattle. SCDM has a limited number of rooms reserved for meeting attendees. When making your reservation, please identify that that you are attending the SCDM Annual Conference to get the best rate.

Interact with us
Become a fan of SCDM on Facebook to view photos and videos from the Annual Conference. New albums will be uploaded before and throughout the meeting.

You can also follow SCDM_DataDriven on Twitter for instant updates on the Annual Conference. Are you tweeting the meeting? Use #SCDM09 to tag your posts.

 Don’t Forget to Claim Your CEUs

The process for claiming continuing education units (CEUs) from the 2009 SCDM Annual Conference will be different than past years. Rather than completing printed questionnaires, session assessments can be accessed through SCDM University online.

An enrollment code and link provided with conference registration materials is required to access the assessments. This new system allows access to session questions through any computer starting October 5. Conference attendees will have until November 5 to complete the quizzes.

Earn CEUs by successfully answering at least 3 out of 5 assessment questions correctly for each session attended. Two attempts are permitted to attain a passing score. Annual Conference attendees can earn up to 1.6 CEUs at this year’s conference.

More Education and CEU Opportunities
In addition to the session assessments, SCDM University hosts online courses. There is still time to enroll for:

  • Project Management for Clinical Data Managers (September 7-October 2)
  • CRF Design (October 12 – November 6)
  • CRF Tracking and Communication of Data Trends (November 9-December 4)

Data Management Plans, an eight-week course offered earlier this summer, was completed by 18 students and will be offered again in early 2010 due to heavy demand.

All online courses are asynchronous – meaning you don’t have to be online at any given time – and led by a faculty of industry experts. Each course addresses domains on the CCDM® exam, contributes to professional development and offers CEU credit. Assignments are tailored to real world situations and allow students to incorporate their own experience as much as possible. To view the schedule and register for courses, visit http://portal.scdm.org.

register

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

Join SCDM's Free Webinar on September 22 and Find Out How

A study group can help you and your colleagues prepare for the CCDM® exam. Joshua Cox and Grant Rempe from Quintiles will be sharing the secrets of their study group success during a 90-minute webinar, September 22 at 11 a.m. CDT. Josh and Grant helped two groups at Quintiles 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. A question and answer period will follow the presentation. Mark your calendar – more details to follow soon.

 GCDMP: Be Part of the Change

You've seen the announcements and press releases about Good Clinical Data Management Practices – new chapters, updated chapters, podcasts. Now is your chance to contribute to these industry-recognized best practices by providing your input and insight on the continued evolution of the GCDMP at the SCDM Annual Conference in Seattle, WA.

Join us for breakfast and discussion on Tuesday, October 6, to learn more about the GCDMP, its significant accomplishments and how you can help its continued improvement. Share with the group ideas for new chapters, enhancements to current chapters, and new ideas for distribution and dissemination of this award winning resource.

We look forward to seeing you there!


SCDM Leadership Forum San Antonio, Texas

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Educational Opportunities

SCDM Leadership Forum San Antonio, Texas


 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:

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

 CRF Design Online Course

CRF Design for Data Managers Online Course Starts October 12, 2009
This asynchronous online course has been designed for anyone directly involved in EDC or paper case report form design, review, development, distribution and archiving for clinical trials. It assumes that learners will have some basic clinical research knowledge and that the course will provide a more expert level of detail in designing case report forms - as well as practice in applying what they learn.

Over four weeks, the course will address general principals, best practices and issues to consider for EDC vs. paper, international trials and standards, and relationship to database structures in all phases of clinical trials.

At the conclusion of the course, learners will be able to:

  1. Describe the importance of a well designed CRF including considerations related to database structure, content, layout and clinical site locations.
  2. Explain the impact of CDASH and SDTM on CRF design.
  3. Design, revise and finalize CRFs according to the study protocol and client specifications while adhering to best practices for CRF design.
  4. Author essential supporting documentation for CRFs, including Completion Guidelines and Data Entry Guidelines.
  5. List and implement data governance procedures for a Case Report Form standard library.

 2009 Webinar Schedule

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

Date Title Sequence
September 10 & 17 Database Validation and Surviving an Audit Certification Sequence
September 22 Study Group 101 Certification Sequence
October 22 & 29 Patient Reported Outcomes Career Development Sequence
November 5, 12 & 19 Project Management Toolbox Certification Sequence

Please read our updated Webinar Terms and Conditions

Archived Webinars

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

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Get Involved

 Volunteer Opportunities

SCDM encourages members to become actively involved in the organization. Volunteering is an excellent way to advance your professional development and broaden your network of professional colleagues.

Click on the taskforce listed for a detailed description of volunteer opportunities.

Products and Services Committee

Education and Professional Development

Marketing and Communications

If you would like to volunteer, please contact volunteers@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:

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.

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News Updates

 SCDM Career Center

Need to find quality CDM professionals to join your team? Look no further than the SCDM Career Center.

Visit today to have access to our unique membership of job seekers in clinical data management. SCDM members are committed to ongoing professional development and staying on top of industry trends.

The Career Center averages more than 1,000 page views per week from CDM professionals from across the country and around the world. Post your job openings today!

 CCDM® Industry Rewards 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

Industry Champion — 50% of CDMs are CCDM®s

Industry Leader — 25% of CDMs are CCDM®s

Partner Level — 10% of CDMs are CCDM®s

 SCDM Board of Trustees Update

Fall is an exciting time of year for the Board of Trustees.

We recently received the results of the Board elections. Three new Trustees – elected by you, our membership – will join the Board in 2010. These leaders were selected from one of the best candidate pools in years, both in quality and quantity. We look forward to announcing these new Board members at the Annual Conference in Seattle!

In addition, this is the time of the year that Trustees are nominated for the Executive Committee. Voting for these roles – vice chair, secretary and treasurer – occurs at the October Board meeting. Current Vice Chair Ralph Russo will assume the role of 2010 Board Chair in January.

Our Chair Linda Talley is working on topics for the October meeting. At our Board meetings, we review our one year goals and our strategic long-term goals. There are also “mega” discussions, which help us stay current on the new trends in Data Management and plan the future of SCDM. These topics can lead us to new strategic goals or confirm that we are on the correct path with our current plans.

We invite you to attend the business meeting Monday, October 5, at the Annual Conference to learn more about the leadership of SCDM. Board members are also easily identified throughout the conference by the brown ribbons we wear with our name badges. When you see us, I encourage you to stop and introduce yourself.

We look forward to seeing you!

Susan K. Howard
Therapeutic Program Manager
Oncology Data Management
GlaxoSmithKline

 Get to Know the CCDM®

SCDM is proud to introduce Ellen Loonan Goldberg, CCDM, as a recipient of the Certified Clinical Data Manager designation. Ellen is Director of Electronic Clinical Data Systems with Writeresult, a division of 3C Company in Basking Ridge, NJ.

Q: Why did you become certified?
A: I felt that certification would help me find the right position when I was searching for a new position earlier this year. I became certified because I felt it would demonstrate to prospective employers and clients that I could and would manage clinical data properly.

Q: What challenges did you have taking and studying for the exam?
A: I wasn’t sure of the best approach to take to study for the exam; I hadn’t taken an exam in years. Having over 20 years of clinical data management experience was a huge plus in adding to my confidence to take the exam. I found the wording of the questions to be challenging.

Q: How has being certified benefited you?
A: I am currently employed by Writeresult, a division of 3C Company, a CRO specializing in digital pen technology. I was hired prior to becoming certified. I manage DM activities and assist my company in contracting for additional DM work by establishing solid client relationships. I feel that my certification encourages prospective clients to use our services; it gives them the confidence that we will use the best DM industry practices for their studies.

Q: What materials did you use to study for the exam?
A: I read through the GCDMP to review the language that was used, and to ensure that I could distinguish between best practices and other practices in studying for the exam. I also used my past experience to respond to the exam questions. I found the sample questions online very helpful.

Q: Can you provide helpful hints for those interested in taking the certification exam?
A: Be confident. Know your material. Review the sample questions several times to acquaint yourself with question wording and types of questions that are asked. Ensure that you’ve read and follow the GCDMP; that is my bible.

Q: Any additional comments you would like to provide?
A: I would encourage data managers and other data management professionals to study for and to take the certification exam. When I’ve hired data managers in past positions, I was very interested in interviewing and hiring CCDMs.


 SCDM welcomed these NEW members in July 2009!

Alba Leticia Aguirre, MD
Ramesh Bapat, BSc
Sanjay Bhardwaj
Andres Busette, BS
Cosmas Collins, BSC
Patrick Compton, MPH
Daniel Durkes, BS
Peggy Fellegy
Julie Fox, BA
Mark Gandara, BS
Clare Geiger, RN
Ashley Hughes, MS
Benjamin Jackson
Roxanne Johnson, BS
Imran Khan, PhD
Jaroslav Koca, MSc
Tsilya Korol, BS
Stacey T. Kosarka
Katherine Kwoh, BA
HyunHak Lee, MS
Ka Ming Lo, MPH
Hamad Mahmoud, MS
Kellie L. McDonald
Brian Morgan, MBA
Robert Musterer, MBA
Haritha Nandyala, BS
Ellie Nikanjam, BS
Saul E. Novoa, BS
Sandra S. Ortiz, MS
Rahul Prakash, BS
Manjula Raja, BS
Rohini Rao, MA
Gayatri Rau, BA
Roxana Sanchez, BS
Adriana Santana, CCDM, MS
Andrea Segal, MEd
Tauhid Siddiqui, BS
Suzanne Siminski, MS, MBA
Pavlina Smekalova, MSc
Summer Smith
Kevin Stephenson, MS
Chad Stimmler, BA, CCRP
Heike Strey
Erik R. Thorne, BS
Prakash Velappan, MBA
Sally Webster, BSN
Karen Whitley, BS
Zhang Yanjuan
Dyuthi Yellamraju
Marlene Zuniga, MS

 SCDM congratulates the following member for entering
her 10th year of membership in July 2009!

Rachel Dillman





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