Japanese Translation of GCDMP Released
SCDM’s comprehensive best practices resource, Good Clinical Data Management Practices, was recently translated to Japanese.
The translation, of more than 300 pages of English copy, was completed through a partnership with the Center for Pharmaceutical Publishing in Toyko and the Japan Pharmaceutical Manufacturing Association.
"Japan has a bustling pharmaceutical industry with many data managers supporting the pipeline of products with high quality data management practices,” said Ralph J. Russo, CCDM, SCDM Board Chair. “Having the GCDMP available in their native language is an ideal way for our Japanese-speaking colleagues to continue fostering best practices in our field."
Good Clinical Data Management Practices is an award-winning resource of best practices produced by SCDM. The GCDMP contains 28 chapters on topics including data quality, database validation, metrics and electronic data capture. It serves as a primary resource for the Certified Clinical Data Manager (CCDM®) exam.
The GCDMP is the first widely accepted set of best practices to be written in Japanese since JPMA published the Green Book in 1994. As homage, the printed copies of the GCDMP are adorned with a green cover.
"The impact of GCDMP translation is immeasurable,” said Osamu Komiyama, vice chair of JPMA’s Biostatistics & Data Management Subcommittee. “Data managers and site personnel have a hunger for a cyclopedic and up-to-date textbook on data management. The Green Book was a bible for Japanese data managers; the GCDMP is their new bible."
Paper copies of the translation are available for purchase through JPMA; an electronic version can be purchased on the SCDM website at www.scdm.org/gcdmp.
Reserve Your Hotel Room Now for Discounted Rates
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The Hyatt Regency Nicollet is the host hotel for the Annual Conference. SCDM has reserved a room block at the hotel to provide attendees with discounted rates. This special rate ends September 17.
Call 612.370.1234 to reserve your room today. Reference the SCDM Annual Conference to receive the special rate.
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By supporting our room block at the host hotel, the Hyatt Regency Nicollet, you help keep conference costs down – savings that have allowed SCDM to hold registration rates flat for three years.
You Asked, We Listened
We've added new features to this year's conference to better meet your interests and needs. Don't miss these exciting new programs:
- Debate Session: The Future of CDM at Sponsor Organizations. Hear from industry experts on the changing roles of clinical data management.
- Device Sequence: Unique challenges in medical device trials. Featuring a roundtable discussion with the U.S. Food and Drug Administration’s Center for Device and Radiological Health.
- Leadership Sequence: An advanced track catering to the needs of senior level management in CDM.
Other highlights:
- Third Annual FDA/SCDM Forum: An update and question-and-answer session with regulatory authorities.
- Data Driven Innovation Award Reception: Highlighting new advancements in clinical data management technology, reception and presentation offered to all attendees and exhibiting companies.
- Exhibit Hall: Network and learn about new products and services from more than 60 CDM industry companies. Become an exhibitor.
Register Now!
Preconference Tutorial Seats Still Available
SCDM will offer three in-depth tutorials on Sunday, October 17, immediately prior to the Annual Conference. Tutorials require separate registration and space is limited.
Tutorial topics include:
- CDISC/CDASH (full day)
- Database Lock (half day, morning)
- Outsourcing (half day, afternoon)
Check out the preliminary program for complete information on these tutorials and all conference sessions.
Don’t Let Opportunity Pass You By
The SCDM Career Center provides the tools to make your employment search efficient and effective – whether you’re actively seeking a new position or just keeping your options open.
The Career Center features the hottest new job openings in clinical data management and is designed to connect top-notch employees with quality companies.
Create an automatic Job Alert to receive e-mail notifications when new jobs are posted. You set the criteria – job title, industry or location.
Sign up today at careers.scdm.org and never miss new job opportunities again!
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| Database Lock and Randomization | October 10 |
| Project Management for the Clinical Data Manager | November 7 |
| 2010 Webinar Schedule | |
| Partnering for Success: Clinical Research Collaborations for Data Quality | September 16 & 23 |
| CDISC | November 11 & 18 |
Smart Collaboration Is Key to Clinical Research Success
Partnering for Success: Clinical Research Collaborations for Data Quality
September 16 & 23 at 11 a.m. CDT
60 minute presentation followed by 30-minute Q & A
Overview
The focus of this webinar is the importance of cross-functional collaboration among clinical research professionals during the clinical trial process to assure data quality. Each participant in the process of data collection in a clinical trial brings their unique perspective to the project based on their role. Sites focus on recording accurate medical information in source documents, clinical monitors verify that data against the case report form, data managers review that data for completeness and logic and then hand that off to statisticians who summarize it for presentation to regulatory authorities. Strategies will be discussed for effective collaboration aimed at avoiding re-work or project delays.
Presenters
Jonathan Andrus, CCDM, manages data and study operations for BioClinica, Inc. In this role, he is responsible for overseeing the design, development, implementation and management of all clinical studies. Andrus previously served as the Chair of the SCDM Board of Trustees.
Ellen Coull, CCDM, is senior project manager and a member of the e-clinical team at PRA with responsibility for the development and delivery of training content for clinical, site and sponsor users of several EDC and supporting review tools. Coull is a member of the SCDM Education Webinar Taskforce.
Objectives
At the conclusion of the program you will be able to:
- Collaborate effectively with clinical research professionals so that your study is as successful as possible and avoids costly rework during the study.
- Implement steps to improve study design through cross-functional collaboration.
- Determine data cleaning methods in conjunction with the CRA to avoid toe stepping.
- Embrace integrated study closeout methods for successful and timely lock.
For more information, please listen to the podcast.
Register Now for Database Lock and Randomization Online Course
Four-week course begins October 10
Register now for early enrollment discount.
The objective of this program is to reinforce those data management tasks that are required for the final preparation of the database release for analysis. What happens when the database is “frozen”? Whose access to the database is removed? We will discuss the answers to these questions and explore in depth the logical progression of those steps to arrive at database lock and describe the documentation that accompanies those processes.
The randomization mystery will also be solved with the understanding of what randomization schemes are all about and when and how these data get applied to the database.
Join us online for a thorough program on some of the most important data management processes that culminate in the final deliverables for the discipline.
Help Plan Online Courses and Webinars
Have you always wondered how SCDM puts together its high-impact webinars? Would you like to go backstage and see how online courses are developed? The window of opportunity is open for you to join one or both of these groups and volunteer your expertise. Here’s what you can expect:
Webinar Sub-Taskforce
Determine topics for 2011 webinars, solicit presenters, attend content review sessions to narrow scope, attend dry runs to provide feedback, vet questions during Q&A session.
E-Learning Sub-Taskforce
Determine topics for online course development. Act as subject matter experts to serve as resources and reviewers of course content. Join our online faculty.
Study Group Sub-Taskforce
If you’re a CCDM®, pay if forward by supporting CCDM exam preparation study groups that are engaged, sustainable, and successful. We will develop creative facilitation techniques and resources that will be readily available from the SCDM website.
To volunteer, send your contact information and interest area to info@scdm.com.
Database Lock Course Developers Needed
Do you love to teach? Is training part of your job? Would you like to give back to the CDM profession?
SCDM is seeking volunteers for the content development team for our next online course, Database Lock & Randomization. Development for this course is scheduled to begin very soon.
Work includes drafting a course outline, identifying content resources, creating slide decks, drafting discussion questions, and creating assessment items. You will be guided by an experienced instructional designer. As an added benefit, you will learn about the process of creating online courses and even be rewarded with participation credits that count toward renewal of your CCDM.
To apply, please send the following to schaplock@scdm.org:
- Short paragraph outlining why you want to join the team
- Your qualifications
- The course you’d like to work on
- A copy of your resume or CV
My Personal SCDM Journey Board update
All of the SCDM committees and taskforces will be featured during a special session at the Annual Conference. If you’ve been interested to learn more about volunteering with SCDM, be sure to stop in. The session is Wednesday, October 20, at 9:30 a.m.
Thinking about this session caused me to reflect on my own SCDM experiences. Ten years ago, in 2000, I attended what was then called the “Fall Conference” in Washington, DC. I was from SmithKline Beecham at the time and we were starting the merger process with Glaxo Wellcome. One of the staff from GW did a presentation at the conference on cleaning labs. I thought at the time that I would never be able to do that. I was so impressed by her.
I took a brave step and signed up to join the SCDM Membership Committee and the GCDMP Committee. I received a great welcome to both committees. The next year, I agreed to do a presentation for the Fall Conference. That year, though, the conference did not occur and was rescheduled for January 2002 in Seattle. Do to the change, many speakers were unable to attend and I ended up doing two presentations – “Surviving a Merger” and “Plans for Moving Forward for Electronic Data Capture.” Obviously, I survived this experience, but I didn’t submit an abstract to speak at the conference again until 2004.
In 2003, I took on the role as chair of the Review and Update Subcommittee for the GCDMP. Then in 2005, I joined the Fall Conference planning committee. It was that year when I found out how difficult it is to chair a session. Make no mistake, this requires a lot of coordination if you are to have a good session. Never assume that a title to a session gives you all of the information you need.
My next step forward occurred in 2007 when I accepted an invitation to be an item writer for the Certified Clinical Data Manager exam. I can still recall sitting in a room looking at questions on processing of paper case report forms knowing that I had very limited experience in this area. Fortunately, I found a partner to work with on the EDC questions and we found someone to send all of our paper processing questions to. This was a huge step for me. I had always felt at a disadvantage in this industry as I had been a nurse for many years, then joined clinical data management and never changed companies. My original goal when joining SCDM was to get to understand how other companies work.
In 2008, I took my biggest step yet. I ran for the Board of Trustees. I was extremely lucky to be successful.
What does this have to do with the monthly Board update? This background has helped me with understanding all of the work of SCDM and has allowed me to meet many of you. Next month, we will have three new members announced for the 2011 Board. We will be orienting them to the roles and responsibilities of being a Board member. The 2010 Board will elect a Vice Chair and Secretary (Treasurer is an appointed position). The Board will meet just prior to the Annual Conference to map out our strategy for the future. We will be meeting to discuss our goals for the next several years for the Society. I urge you all to reach out to us and let us hear what you want. If you want to share anything, please feel free to contact me at Susan.K.Howard@gsk.com.
I hope this encourages a few more members on their SCDM journey. Please don’t assume my journey is ending anytime soon. I’m learning too much and enjoying myself! I do hope you all will start your own SCDM experience. You can exercise your leadership skills, writing skills, negotiation skills, and presentation skills. Join us at the Committee Session at the Annual Conference to start your journey.
I look forward to meeting you along the way!
Susan K. Howard
Secretary
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Ajesh Sukumara Pillai, CCDM, as a recipient of the Certified Clinical Data Manager designation.
| Q: | Why did you become certified? |
| A: | The CCDM certification is a credit to my profile and it also affirms my commitment to this profession. This also proves my commitment to personal growth and continuous learning. This certification is highly recognized in the field of clinical data management and is a good thing to possess for experienced clinical data managers. It’s also a preparation for increasingly responsible positions in the industry.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | The main challenge was gathering information. It was difficult for me to find a study group regionally, but I was able to find one inside the company. The second challenge was to know what to learn, but after attending the webinar on preparation of CCDM, it became easier. |
| Q: | How has being certified benefited you? |
| A: | It was well appreciated by my peers and senior management. I hope that the sponsors will be more confident in the abilities of the team, which includes me. It's too early to comment on other benefits. Moreover, the preparation for the certificate has benefitted me a lot; I can see that I have referenced a higher number of articles or books than I used to, thereby increasing my knowledge in the different areas of CDM and clinical research.
|
| Q: | What materials did you use to study for the exam? |
| A: |
Mainly, the GCDMP document from SCDM. I also went through the DHP Guidelines provided by the Association of Clinical Data Management, ICH GCP E6, Management of Data in Clinical Trials by Eleanor McFadden, Paragon Biomedical’s SOPs and, of course, the timely help and guidance provided by my colleagues. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
This exam is arduous and it requires ample knowledge to clear it. The specifications are more on knowledge of data collection methods and identifying the important data and dealing with it. Knowledge of guidelines such as 21 CFR Part 11, GCP, and ICH guidelines is essential.
|
| Q: | Any additional comments you would like to provide? |
| A: |
To prepare for the exam, read the GCDMP thoroughly, brush up on your knowledge of CDM, go through industry guidelines like ICH and FDA and, most importantly, trust your experience. Your experience really counts. The questions are mostly application oriented and are mainly from real life data management scenarios. There is enough time to answer the questions – be patient to complete the exam and review the answers again. Good luck to all who are planning to take the exam.
|
Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to info@scdm.org.
SCDM Welcomed These NEW Members in JUNE 2010!
|
Francesco Accardi Kerri S. Andrews Phellisha Ausler Jeanne Barkman Wendy L. Bertrand Wilma S. Bosse Napakkawat Buathong Michael Burton Michelle Cass Todd Colbeth Linda M. Conboy Denise R. Coppage Matteo D'Acri Teresa Davis Erica L. Dodd Lauren Duncan Carla Y. Eaddy Jennifer L. Fairbanks Frances Flores Remi Gauchet Corina Güthlin, PhD Dulce I. Gutierrez, RPh Chiaki Hashii Cheryl Hergert, MPH Devin J. Hunt Aditya S. Karkare Radhika Kondapaka |
Trudy Kuipers, MSc Rebecca Lindstrom Becky Lippincott, CCRA Suzanne Madsen Kaey Marshall Paileen Mongelli Attila Olah Joan A. Ozor James R. Pedzinski Georgiy Pitman, MS Sathyavathy Ramanathan Carolynne Ruelas Hector R. Samuel Gabriela Sartorio, BBA Leanne Selby Jennifer I. Semeter Anthony Silva Glenda Singer Donna Syverson Norio Tamura Venkatesan Thangaraj Rosana M. Thomas Janis H. Vergara Greg Wagner Pai-Lun J. Wang Theresa Wong |
SCDM Congratulates the Following Member for Entering
Her 5th Year of Membership in June 2010!
| Tsz Ying Man, M.Sc, CCDM, CCRP |
Effective R&D SOPs, Process Maps, & the Quality System
Henry Stewart Events
September 14
Washington, DC
This conference covers:
- The latest methodologies, tools and technology for the development and implementation of R∓D SOPs
- Latest thinking on best practice
- What industry leaders are doing, and what everyone should be doing to ensure effectiveness, efficiency and quality assurance.
This conference is essential for:
- SOP writers
- R&D functional area / department managers
- QA auditors
- QA managers
- Training managers and staff
For further information please visit: http://www.hsconferences.com/page12631354.aspx or contact Julie Kerry at juliek@henrystewart.co.uk.
Data Collection and Management in Clinical Trials Asia 2010
November 24-25
Beijing
The Data Collection and Management in Clinical Trials Asia 2010 is the first event exclusively focusing on patient compliance and data management strategies in Asia, an area of increasing popularity for building world-class data management centers. The event will gather key pharmaceutical companies, CROs and regulatory officials, as well as data capturing and management solution providers, together under one roof. It will discuss opportunities and form strategic partnerships to leverage the enormous amount of opportunities the region has to offer.
For more information, visit www.clinical-trial-data.com, e-mail enquiry@iqpc.com.sg or call +65 6722 9388.
