Cast Your Vote for Board of Trustees
It's election time! Voting is now open for the Board of Trustees election.
The Board of Trustees is composed of volunteer members who guide the direction of the society - through strategic planning, policymaking, and overall management.
There are three open seats on the Board. All members, student members and corporate members are eligible to vote. Voting closes Friday, August 20.
The candidates are:
- Jonathan Andrus, Vice President, Data and Study Operations, BioClinica, Inc.
- Jennifer Duggan, Manager, Clinical Data Management, St. Jude Medical
- Thomas Grundstrom, Vice President, Global Data Solutions, Quintiles
- Nara Gubbala, Manager, Clinical Data, Boston Scientific
- Marysasser Hedrick Holloway, Senior Director, Data & Analytical Services, ClinForce LLC
- Dawn Kaminski, EDC Product Manager, Octagon Research Solutions
- Meredith Nahm, Associate Director, Clinical Research Informatics, Duke University
- Amy Plodek, Senior Manager, Clinical Data Management, Boston Scientific
- Pat Stetser, Senior Manager, Covance
Read candidate profiles and cast your ballot online.
SCDM 2010 Annual Conference
Data Driven Innovation Award Applications Due Friday
The Data Driven Innovation Award recognizes the year's best developments in CDM technology or service. Don't miss this unique opportunity to highlight your company's achievements!
Award finalists will demonstrate their product during the SCDM Annual Conference, with a winner announced at the Data Driven reception Monday, October 18. Learn more about the award.
Preconference Tutorial Information 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.
Please note that tickets to this year's Data Driven reception are limited. Register early to reserve yours!
Register Now!
New for 2010:
- 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.
Reserve Your Exhibit Space Today!
The exhibit hall is a thriving component of the SCDM Annual Conference. Make sure your company is represented among top industry players representing pharma, biotech, device, contract research and technology companies.
GCDMP Adds New Chapter on Project Management
Vendor Selection Chapter Revised
It's time to update your GCDMP! Download the new chapter Project Management for Clinical Data Managers and read the revisions to Vendor Selection and Management.
Remember, as an SCDM member you receive unlimited access to the GCDMP.
Podcasts for these chapters are in production.
SCDM thanks the following subject matter experts for their significant contributions toward the development of these chapters.
Vendor Selection and Management:
Thomas Alummootil
Sandra Hudgens
Frank Monaco
Denise Redkar-Brown
Outsourcing Focus Group members
Project Management for Clinical Data Managers:
Eugene Hayden
Marysasser Holloway, CCDM
Melissa Lamb
Lori Nowland
Holly Watts
NEW: SCDM Membership Hardship Policy
The Society for Clinical Data Management recognizes that unemployment may result in financial hardship and leave members unable to pay their regular SCDM dues.
We believe that your membership in SCDM is never more valuable than when you are seeking new employment. Our career center, networking opportunities and education programs are valuable resources during these times of transition.
Pursuant to this belief, SCDM will waive up to one year of membership dues for members who encounter economic hardship due to loss of employment.
Dues renewal for 2011 begins in October. If you are unemployed and would like to apply for a dues waiver, please download the application and verify that you meet program criteria.
Recipients of a dues waiver will be contacted quarterly by SCDM staff for an update on employment status. At the time that employment is attained, members may be invoiced for prorated dues through the end of the year.
To request hardship assistance, complete the application in the Membership Policies section of the SCDM website and return it to the SCDM administrative office. Download an application.
Protocol Review - Everything You Always Wanted to Know but Were Afraid to Ask
August 12 & 19
11 a.m. CDT
60-minute presentation followed by 30-minute Q&A
Listen to a preview podcast
Tune in to a conversation with presenters Dawn Kaminski and Dan Crawford as they discuss the topics they will address in the upcoming webinar.
The protocol "describes the objective(s), design, methodology, statistical considerations, and organization of a trial." (ICH GCP E6) It is the essential document from the clinical data management perspective describing the conduct of a clinical trial. A well-written protocol includes clear protocol objectives, detailed study design and time and events schedule, and statistical methodology. Using the protocol, Case Report Forms can be effectively designed and databases setup to collect all data needed for eventual statistical analysis of the clinical trial data.
Presenters
Dawn Kaminski, EDC Product Manager, Octagon Research Solutions
Dan Crawford, Director of Clinical Data Strategies, Octagon Research Solutions.
Outcomes
- Review the components of a clinical trial protocol as defined by the ICH GCP E6.
- Determine the essential protocol components for effective clinical data management.
- Detail the required information from protocol components for effective clinical data management.
- Describe how to translate the essential protocol information into a clinical data management information system.
Continuing Education Credit
SCDM is authorized by IACET to offer .4 CEUs for this program.
Processing Lab Data
Four-week online course beings September 5
This course will focus on the local labs that may be captured via CRF that will involve the maintenance of laboratory normal ranges as well as the concept of conversion to Standard SI Units for data display. The QC/QA of these data and associated edit checks to ensure data integrity will also be discussed. The process of management of electronic data transfers from a Central Lab environment, reconciliation process and the technical aspects to prepare a Data Definition Document and Data Transfer Agreement will be presented.
This course is intended for intermediate/advanced CDMs.
About Online Learning
This four module course is available to you online from SCDM University where e-learning is engaging, active, facilitated by expert practitioners, and directly applicable to your job. While there are assignment deadlines, access is available 24/7, and you are part of a small cohort of students that may quickly broaden your network of professional contacts.
Register now for the early enrollment discount.
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| Processing Lab Data | September 5 |
| Database Lock and Randomization | October 10 |
| Project Management for the Clinical Data Manager | November 7 |
| 2010 Webinar Schedule | |
| Protocol Review | August 12 & 19 |
| Touch Point/Hand Offs (with SAE Reconciliation) | September 16 & 23 |
| CDISC | November 11 & 18 |
Submit Your Proposals for 2011 Webinars
Webinars are one of SCDM's key learning strategies to address timely issues impacting clinical data managers. Interactive, live, and commercial free, SCDM webinars target a full range of experience levels on topics supporting career development and certification.
If you have an idea for a webinar and would like to be one of SCDM's presenters, submit your proposal today. Applications will be accepted through August 16.
Never presented a webinar before? SCDM's education staff will coach you through the entire webinar development and presentation process. You'll have ample opportunity to practice using our WebEx tool so you'll be polished and ready to present. Take this opportunity to learn a new skill and share your knowledge. Submit your proposal today.
WANTED! Short-Term SCDM-GCDMP Volunteers
Subject Matter Experts needed to review the next Good Clinical Data Management Practices (GCDMP) chapters scheduled for creation or revision.
SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Detecting Fraud, Risk Management and Training.
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 guidance
- Must have the available time needed to serve in the capacity of SME, estimated to be approximately 30 to 40 hours over the course of the assignment
Work will begin as soon as SME's are identified and continue until chapters are complete - approximately two to three months.
SMEs are eligible to receive participation credits, which can be used toward certification renewal.
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 Amanda Knack at aknack@scdm.org.
SCDM Groups Forming Now to Plan 2011 Online Courses and Webinars
Have you always wondered how SCDM puts together those high-impact webinars? Would you like to go back stage 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.
BoT Update
The Board of Trustees met July 9 in San Antonio, Texas. We received an update from our Committee Chairs on the work their groups have done and were planning.
It was reported that the Annual Conference Taskforce plans are proceeding well. The Annual Conference team has a very exciting agenda for this year's event. There will be a debate on the future of CDM in pharma organizations. There are several tutorials planned at the Annual Conference again this year - information is now available on the SCDM website.
The GCDMP Taskforce reports several chapters are being rewritten and there are several new chapters under development. Also, we celebrated the recent translation of the GCDMP document to Japanese.
The Certification Taskforce has a group of item writers developing or modifying some of the questions on the exam. This review takes place on a routine basis.
Marketing and Communications are exploring ways of enhancing the visibility of SCDM internationally by meeting partnerships and program expansion. They also continue to explore the use of social media to reach our members.
We discussed the upcoming elections for the Board of Trustees and our Board member orientation for these new Trustees. Be sure to cast your ballot today, or at least before voting closes on August 20.
Our next face-to-face Board meeting will be on October 16 in Minneapolis with the successful candidates for the 2011 Board of Trustees!
Susan K. Howard
Secretary
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Vageesh Kumar S.S, CCDM, as a recipient of the Certified Clinical Data Manager designation.
| Q: | Why did you become certified? |
| A: | Throughout my existence in the CDM arena, I always felt the need of professional commitment and CCDM was the only way of achieving this credential.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | Biggest challenge was TIME - I hardly got few hours of time to brush through before the exam and had to depend entirely on the hands-on experience. Apart from time, to a lesser degree the challenge was unavailability of a proficient resource to clear all the confounding doubts on the topics covered. |
| Q: | How has being certified benefited you? |
| A: | Apart from the sense of accomplishment within, this certification demonstrates to my competitors and customers the use of industry-respected best practices.
|
| Q: | What materials did you use to study for the exam? |
| A: |
Apart from GCDMP primarily, CDISC standards, few FDA/EMEA guidance and regulations, few research articles and blogs read over a period of time during formative years helped me prepare for the exam. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Never get anxious on the pattern/questions of the earlier examinations, concentrate entirely on the newer areas where one has never worked on and believe in your hands-on experience of the already familiar areas. The acquired experience will always come handy.
|
| Q: | Any additional comments you would like to provide? |
| A: |
When faced with ambiguity while answering few questions, use the logic of predicate rules of GxPs in a conservative manner.
|
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!
|
Samar Abidi, MS Kyle Andrews Katherine Arbour Mary Ann Auld Samatha Bandi Smita Barua Melha Battou Laurie S. Benyair Tina Boss Jami Brown Kristen Camping Bola A. Coker Stella Dolci Denise N. Edmonds Kaye H. Fendt, MPH La Tanya Garvin, MBA Sandra D. Gonzalez Kerry Gray Chad Harris Aleatra B. Heyward Brian Hoffman Nicola G. Hunt, CCDM, HBSc. Gloria Jones Sachin Kansagara Joe Laver Larry Lee Jacquelyn Margolis Joanne McCaigue, CCDM Jennifer McCormick Steve Moloney Valerie Moore, BS Bernice Newman Diane A. Nix Regina Norelli Chinnie E. Nwandu, BSc, MSc |
Susan Okonkwo Felisa L. Paschal-Hicks, Ph.D Angela Pitts Mindaugas Radavicius, MSc Krisztina Robbert Cynthia J. Robinson Michelle Roets Waraporn Sakornjun Elinor Schoenfeld Gyo Chan Shim Sherry Smoot, MS Maria D. Springer Christopher Stack Shari Swanson Nate Thibault Kristine Volker Laurie Vonderharr Andrea Vortruba Jinny Walz Robin Wieskus Heike Woehling Mary Wyse Tami Yardeni-Nadiv Gisella Lopez Blanchette, CCDM Danyel Crout Carr, MS, CCRA Karen Dhami, CCDM, CCRP Jacqueline Flournory Elizabeth L. Graf Cheryl R. Haseman Karina Hinkle Lisa H. King Angela L. Lee, MPH Angela McFadden Ryan E. Whitworth, MPH Stephanie S. Willis |
SCDM Congratulates the Following Members for Entering
Their 5th Year of Membership in June 2010!
|
Karen Dhami, CCDM, CCRP Angela L. Lee, MPH |
DIA 4th Annual Clinical Forum Lisbon 2010
Now celebrating its fourth year, the DIA Clinical Forum - Europe's premier conference for clinical professionals - will be held at the Lisboa Congress Centre in Lisbon, Portugal from 11-13 October 2010.
Register now and take advantage of the €200 early-bird discount - available until 27 August 2010.
More than 35 sessions over two and a half days will cover key issues relevant to pharmaceutical and biotech professionals from academia, CROs, clinical trial sites, SMOs, health regulatory agencies, patient organizations and students.
Presentations from more than 130 dynamic speakers, inspired by the conference theme "Navigating the Future", will provide case studies and practical approaches to all aspects of clinical trial delivery. Nine exciting tracks, listed below, offer attendees a choice of sessions across multiple disciplines:
- Clinical Data Management/eClinical
- Clinical Operations
- Clinical Research
- Peri- and Post-Approval Studies
- Drug Safety and Risk Management
- Quality Assurance
- Clinical Endpoints
- eTechnology and Validation
- Medical Information and Communications
This year's provocative plenary debate, "This House Believes That Increasing Bureaucracy Is Killing the Future of Clinical Trials", will continue the Clinical Forum tradition of the successful plenary debate and will be of great interest to our audience.
Several structured tutorials and workshops will be presented including one specifically for the future of the regulatory clinical trial environment.
Download the flyer or visit the interactive new Clinical Forum website.
For more information visit www.diahome.org click on the Clinical Forum icon or call +41 61 225 51 51.
VIBpharma debuts its successful Lab Data Management Europe event in Boston, MA, on September 22-23.
Register now for this must-attend event designed to provide you with critical insight into overcoming the key challenges of moving toward a truly integrated electronic lab. Find out solutions to streamlining your lab R&D workflow, to managing large quantities of data effectively, integrating ELNs and LIMS and much more.
By registering at: http://www.arena-international.com/pharma/laboratorydatausa/register.asp, you'll network and share experiences with representatives from Bristol Myers Squibb, AstraZeneca, Genentech, GSK and many more. As an SCDM member we would like to further offer you a 10% discount on the registration when you use the code: SCDM.
If you need further information please contact Melissa Fuentes at book@vibevents.com.
