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

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 and 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 Nesse, 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.

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 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

IN OTHER NEWS

SCDM July Board of Trustees Update

by: Derek Perrin

I hope everyone is enjoying their summer and taking lots of well-deserved vacation.

Earlier this week I had the good fortune to attend and participate in the "Introduction to Data Collection and Data Management Practices in Cancer Research" webinar. The webinar presenter, Elizabeth Ness, B.S.N., M.S., of the National Cancer Institute gave a very engaging introductory session on the challenges in managing Oncology clinical trial data. At Pfizer, one of my roles is to support Oncology clinical trials; from the presentation was very beneficial for me.

Post webinar feedback from the session was overwhelmingly positive, with one attendee commenting, "This was the best webinar I have attended". I would like to extend a personal note of thanks to Elizabeth for hosting such a great session, as well as extend gratitude to Sharon Chaplock, SCDM Director of Education & Sue Abrahms, SCDM , Education coordinator for their support in organizing and executing this presentation.

The next series of webinars take place this Fall; after the SCDM Annual conference, and will focus on Outsourcing in Data Management, the unique opportunities and challenges of working in Asia from both the Clinical Research and CDM Perspective. More details will be forthcoming on the SCDM website at www.scdm.org.

Next on the calendar is the Board of Trustees meeting in Milwaukee; home of the SCDM Administrative office. On August 1st the board will convene for our third face-to-face session of the year. During this meeting we will focus our discussions on board development and begin to strategize for the coming year. The next issue of Data Connections will include a brief summary of our meeting.

Finally, I would like to extend my appreciation to Aaron Miller, SCDM Meetings Manager for his outstanding support in organizing and planning of the 08 Annual Conference. Aaron will be leaving us to start a new charter school in the Milwaukee area, as well as finish his Master's degree. Despite his departure on July 30th we are in very good shape as the exhibit hall is now full, registrations are filling the Administrative office inboxes and all presentations are well on their way to completion. Please join me as I wish Aaron the best of luck in his new career and thank him for all of his contributions…he will truly be missed!!!

Enjoy the rest of your summer; I will chat with you in August.

Derek Perrin, CCDM

SCDM Welcomed these NEW Members in June 2008!

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

JoAnn Licari
Garnetta Rice Brou
Annie Solterbeck
Janet Welsh, CCDM

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

Anna M. Gonzalez
Greg M. Dziem
Charlotte Patterson