IMPORTANT ANNOUNCEMENTS

It's not too late!

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. A dedicated and hard working 2008 Fall Conference Committee created a program targeted toward individuals in the discipline of Clinical Data Management. You can find detailed conference information at http://www.scdm.org/events/fall2008/.

GCDMP - EDC Chapters Released

After a little over two years, SCDM is pleased to announce the finalization and release of three new EDC Chapters, covering study startup, conduct and closeout activities. These exciting new chapters provide the industry with a great resource for understanding how best to go about implementing, maintaining and closing out EDC based clinical data studies. With the contribution and help of many, this was a momentous effort. Each section was led by a team of subject matter experts. SCDM would like to acknowledge the leaders of these teams: Study Startup, Deb Jendrasek and Ralph Russo, CCDM; Study Conduct, Terri Hicks and Marco Van Doevern; Study Closeout, Jonathan Andrus, CCDM and Paul Clarkson, CCDM.

SCDM is sure that you will find great value in this chapter as you navigate the world of EDC.

SCDM Authorized Provider of IACET CEUs

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

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 submission requirements.

"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

SCDM CLASSIFIEDS

Subject Matter Experts Needed

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 begin by mid-August and 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

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 September Board of Trustees Update

by: Derek Perrin

It's hard to believe that after almost another full year of planning, the SCDM Annual Conference is now upon us. We've got a jam packed agenda in store, and I am very excited to have played a role in planning this year's event. Monday night will be especially exciting as we will be hosting the 2008 Data Driven Innovation Award ceremony at the Texas Stadium, complete with a Texas BBQ. For you football fans out there, this will be your chance to not only congratulate this year's winner of the Data Driven Innovation Award, it will also be one of your last opportunities to see the home of the Dallas Cowboys, before it is demolished at the end of this season. Special thanks to DSG for their sponsorship of this event. Believe it or not, if you have yet to register for the Fall Conference, it's still not too late. Look for all of the details at the following link: https://www.scdm.org/events/fall2008/default.asp

The results of the SCDM Certification Beta Exam are complete. It makes me very happy to share that over 300 people took the Beta Exam, and of that number, 182 passed and are now CCDMs. This brings SCDM's overall number of CCDMs up to 330. What's more impressive is that since last year's Fall Conference a total of 221 people joined the CCDM ranks…not too shabby for one year, and with an accelerated timeline to boot! To each of our newest CCDMs, you have my congratulations and thanks for helping us to validate the new exam.

For those of you attending the Annual Conference, I look forward to seeing all of you in Dallas next week. For those of you that know me, you'll get to see a rare event…I will actually be in a suit on Monday (and Monday only)!!!

Have a terrific beginning of Autumn!

Derek Perrin, CCDM

Certification Committee News

New CCDM EXAM
The Certification Committee has been working very hard to prepare and launch the new CCDM exam at this Fall's SCDM Conference. We are happy to report that, with the help of volunteer SMEs, we were able to revamp the exam and add competencies in Project Management and EDC to the new exam. These competencies have become an essential part of a Data Manager's responsibilities.

Exam Workshop at the Fall Conference
Look for the morning sessions at the Fall Conference to help prepare you for taking the exam.

Preparing for the CCDM Exam: an Insider's View

• Why be certified?
• Setting up the appointment
• Logistics on exam day
• Notification of results
• Test taking strategies
• Preparation resources
• Forming a study group

Monday, September 22, 7:30 a.m. - 8:30 a.m.
Tuesday, September 23, 7:15 a.m. - 8:15 a.m

Certified Clinical Data Managers
As can be seen from the SCDM website, the number of CCDMs has been increasing steadily. We are very pleased to report that we have surpassed our target for 2008 and have almost tripled the number of new Certified Clinical Data Managers since 2007 and the year is not yet up!

In order to support our growing number of CCDMs, SCDM has developed tools such as CEU tracking, multiple training opportunities annually and web-based access to complete certification information. We are also working on more ways to support our CCDMs and we will keep you posted. Please forward any suggestions you may have to sabrahms@scdm.org

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 Kyle Hart as a recent recipient of the Certified Clinical Data Manager (CCDM) designation.

Why did you become certified?
I became certified for three reasons. First, I feel that increasing the number of certified individuals adds value to the certification and to the society at large. Second, preparing for certification filled my brain with a lot of new information that adds value for my employer. Finally, I believe that having the certification increases my employability and helps me stake my claim in the field of clinical data management.

What challenges did you have taking and studying for the exam?
Taking the exam wasn't particularly difficult, thanks to the extensive preparation I did. The difficulty was in preparing for the exam. The guidance that the society offers for studying is vague, and the list of suggested reading includes a vast amount of material, most of which is prohibitively expensive. Fortunately, members in discussion forum offered a list of public-domain materials that were relevant and concise.

How has being certified benefited you?
The primary benefit has been in what I've learned from preparing for the exam. There are a number of strategies and documents that I didn't use before becoming certified. I'm doing things now that I think will make our next studies run more smoothly. Also, now that I've done a lot of reading and I've been tested, I'm much more confident in making decisions as a data manager.

What materials did you use to study for the exam?
FDA's Guidance for Industry: Part 11, Electronic Records; Electronic Signatures--Scope and Application (August 2003)
"Welcome to the Who Drug Dictionary" (www.umc-products.com/graphics/2489.pdf)
FDA's Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Content of Labeling (April 2005)
ICH E9: Statistical Principles for Clinical Trials (September 1998)
ICH E3: ICH Structure and content of clinical study reports (November 1995)
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (March 1995)
FDA's Guidance for Industry: Computerized Systems Used in Clinical Trials, Draft Guidance (September 2004)
FDA's The CDER Handbook (http://www.fda.gov/cder/handbook/handbook.pdf)
Kush, RD. eClinical Trials: Planning and Implementation. Boston, MA: Thompson CenterWatch; 2003.

Can you provide helpful hints for those interested in taking the certification exam?
I think the most useful information is the list of references above. Beyond that, I suggest basic study techniques: Study a little bit every day for a month or more, instead of trying to cram the week before the exam. Get plenty of sleep the night before the test. Buy a case of Red Bull just in case.

Any additional comments you would like to provide?
To those considering certification: I wholeheartedly recommend going for the certification. It will be good for your career, and it builds a network of certified professionals, which helps us standardize our practices, build a network, and learn from each other. It shows your affiliation with SCDM, and it promotes the society.

SCDM Welcomed these NEW Members in August 2008!

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

Karen L. Baldwin
Nelly Connolly
Patricia Mineur
Bethann E. Schrader
Holly Wiles

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

Rebecca D. Kush, PhD
Julie E. Rardon