Registration for 2009 SCDM Annual Conference to Open in June

Please join us for the clinical data management industry's premier education event, the 2009 SCDM Annual Conference, October 4-6 in Seattle, WA.

Please visit www.scdm.org/events/fall2009/ for Annual Conference Information.

This year's meeting will provide CDM professionals of all levels with exceptional professional development opportunities. Our schedule of educational sessions is divided into two tracks, so you can attend the presentations that are of most interest and most relevance to your work responsibilities.

Two exciting keynote speakers will share years of experience and insider tips to help you add value to your company and improve your work performance:

• Diane Jorkasky, former Pfizer executive, discusses the importance of leadership in clinical data management
• "Productivity Pro" Laura Stack, a professional speaker and time-management expert, will provide strategies for increasing productivity at your workplace.

Our second annual SCDM/FDA Forum will update conference attendees on the latest government initiatives and regulations impacting clinical data management.

Be sure to attend session VI-A, where a representative of the Metrics Champion Consortium will share the MCC's initiatives to standardize data measurement.

And you won't want to miss the Data Driven Innovation Award reception at the Experience Music Project, an interactive music museum. Open to exhibiting and sponsoring companies, the Data Driven Award honors the best advancements in clinical data management technology or service. Submit your entry online through July 24.

If your company hasn't signed on as a sponsor or exhibitor yet, there are still limited opportunities available. Contact Marketing Director Jean Wenzel at 414.226.0362 or jwenzel@scdm.org to reserve your space today.

We look forward to seeing you in Seattle!

 Read Latest Standards in Revised GCDMP

SCDM recently released three revised chapters to Good Clinical Data Management Practices (GCDMP), our award-winning resource of best practices in CDM.

As an SCDM member, you can access these chapters individually, and as often as you want, free of charge.

• Data Privacy now contains more in-depth discussion of regulatory definitions of what constitutes private data, specific areas of focus in protecting private data, and how data privacy regulations may impact studies operating over multiple regulatory jurisdictions.
• Database Validation, Programming and Standards includes expanded information on distinctions between systems validation, study-specific validation and user acceptance testing.
• Medical Coding Dictionary Management and Maintenance updates information about MedDRA, WHO Drug and customized medical coding dictionaries

Podcasts for the chapters are in development and will be posted to the Web site upon completion.

SCDM relies on volunteer experts to guide content in the GCDMP. If you're interested in advising on future chapters, please e-mail volunteers@scdm.org. For a list of current expertise needs, please see the article in the Get Involved section of this newsletter.

Thank you to the subject matter experts who contributed to the development of these revised chapters.

Data Privacy: Teresa Ancukiewicz, MA, CCDM; Susan Howard; Patricia Stone, CCDM

Database Validation: Len Grunbaum; Carolyn Lozier; Hieu Ly; Donna Medeiros; Olivia Montano-Tritz, CCDM; Urmi Parkar; Timothy Peters, CCDM; Joseph Pokorny, CCDM; Paul Rutti; Katherine Straub, CCDM; Annette Travalent;

Dictionary Management: Paul Ackermann, RN, CEN; Henry Chen; Debra Klein; Connie Krause; Nina Maris; Cheryl Maslanka-Uken; Eileen Monge; Lisa Nastari, RN

 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

• Certification Taskforce
• GCDMP Taskforce
• Membership Taskforce

Education and Professional Development

• Mentoring Taskforce
• Online Courses/Tutorials Taskforce
• Self Assessment Taskforce
• Webinar Taskforce

Marketing and Communications

• Publications Taskforce
• Marketing Taskforce

If you would like to volunteer, please contact volunteers@scdm.org.

 Exhibit and Sponsorship

Associate your Brand with... The 2009 SCDM Annual Conference, October 4-6 in Seattle, is the premier professional development event in the CDM industry. Each year, more than 600 clinical data managers and related professionals attend the SCDM Annual Meeting for educational sessions, networking and social functions.

These attendees represent the pharmaceutical, biotechnology and medical device industries; contract research organizations; academic research centers; regulatory agencies; and related product and service vendors.

Our sponsorship program is designed to:

• Draw attention to your organization's commitment to the CDM community
• Establish a positive brand identity for your company and create marketing experiences with both current and potential clients
• Build a sense of pride among your employees through the support your company shows for SCDM's mission, vision, work and members

Extraordinary Marketing Value
The actual marketing value of all of our sponsorship levels exceeds the investment. In addition, sponsorship of the conference provides your organization with a unique opportunity to interact and market to the most influential leaders in the field of clinical data management.

All sponsors except the bronze level receive a booth in the Annual Conference exhibit hall. This is a thriving portion of the conference, giving companies an unparalleled forum to build and solidify relationships through person-to-person marketing and communication.

There are still select sponsorship opportunities available:

PLATINUM LEVEL SPONSORSHIP: $12,000
Conference Notebooks
Conference badge holders

SILVER LEVEL SPONSORSHIP: $7,000
Pre-Conference Tutorial

BRONZE LEVEL SPONSORSHIP: $3,000
Afternoon Break (two available)
Data Driven Award Reception photos - a unique keepsake for event attendees

EXHIBITOR
Limited booth space remains.

PROGRAM ADVERTISING: Pricing varies
Advertising space is still available in the final program. Reservations and materials are due by July 31.

Contact Jean Wenzel, Marketing Director at 414.226.0362 or jwenzel@scdm.org to reserve your sponsorship or to customize a program that meets your unique marketing goals.

 SCDM Board of Trustees Update

Changes and Challenges Add to Career Rewards

I've talked to many people over the last few months both in data management and in other careers. My findings, while unscientific, show that most of the people in data management truly love what they do. (There is the occasional person that is unhappy reporting to their current manager or in a company they do not feel like they fit.) Many of the people in other lines of work discussed their job, not their career or passion.

While many do not understand what we do, clearly there are unique qualities in all of us that do this type of work and feel passionate about it. There is truly a feeling of doing work that will help people - through our small role, but critical, role in bringing a new medical device or drug to market. There is also the challenge of trying to predict or control the uncontrollable. Our timelines can be affected by any number of factors beyond our control. Natural disasters, changes in laws, a study coordinator's vacation - any of this happening anywhere in the world - can impact our timelines. We take on and often relish these challenges. We know delays cost our companies and sponsors. We stay late and recruit others in the challenge of meeting or beating our given timelines.

We love the challenge of finding those data issues - that one data point that does not make sense - or fixing a programming issue. We often try to figure out what happened when we are missing doses, and then we query. Whether we are designing the CRF's, working on queries, programming, coding terms or overseeing the project management aspects of data management, we find that no day is the same. There will be a new programming challenge, a site that needs to be retrained on the protocol, a new drug we can't find or a challenge to write a new a query since the site did not understand the initial one. When all else fails, the technology changes.

I can look back over my 15-year career in this industry and easily identify many changes. When I started, there were not computers on every desk. We didn't sit in front of the computer all day. Rather we looked at listings and check output with a paper CRF. Electronic data capture was being piloted and everyone felt that in five years it would be common practice - interestingly, that is still not true. There were no discussions of electronic health records. Regulatory audits were not routine as they are now. Personally, I'm glad I found this new career. There are always new challenges in this industry.

As I look to the future, I'm hopeful that there will be more EHR adoption as a result of mandates and challenges posed by the Obama administration as well as other governments around the world. I dream of a time a when more data is moved electronically rather than transcribed several times before being entered. We will find need to find new ways to work and develop more efficiencies. Companies of the future will have one database for pharmacovigilance. We will reduce the amount of manual reconciliation done. If we are to stay vital as a profession we must be efficient and cost effective.

I challenge you all to question how we work. Ask yourself if we are doing things just because it is the way they have always been done; or is it truly the best way? We need to share what we do with our upper management. Too often, we are invisible workers. We must change and be innovative and vocal. Stay or get involved with SCDM to keep on top of best practices and new trends. It has made my career truly more rewarding.

Susan K. Howard
Therapeutic Program Manager
Oncology Data Management
GlaxoSmithKline