Thanks for Making the 2011 Annual Conference a Success!

The 2011 SCDM Annual Conference in Baltimore was a huge success and we thank the attendees, speakers, sponsors and exhibitors who made it all possible.

A special thank you goes to our conference co-chairs, Charlene Dark and Jeanne Ashton for their leadership and vision. We also thank the members of the Annual Conference Taskforce: Tonya Arthur, Jaime Baldner, JoAnn Beall, Colleen Cox, Christine Cramer, Kelley Fisher, Nicole Saleh Gallegos, Clare Geiger, Thomas Grundstrom, Casey Higgins, Marysasser Holloway, Kumar Komuravelli, Rebecca Loding, Jessi Odle, Derek Perrin, Jim Peterson, Carol Ann Schaffer, Gail Speakman, Katherine Mortali Straub, and Dorothy Stokes.

The conference would not have been possible without your hard work and dedication!

This year’s conference offered attendees the opportunity to enhance their careers through world-class education sessions and provided a unique platform to shape important industry connections. Those who joined us in Baltimore experienced:

• Over 15 education sessions, providing attendees with valuable and practical knowledge that will enhance their proficiency in the CDM field
• 3 specialty pre-conference workshops, featuring in-depth instruction on important topics in CDM
• Product demonstrations, offering sponsors the chance to showcase their latest products and services to attendees in an intimate setting
• The fourth annual FDA-SCDM Forum, a panel discussion with regulatory authorities from the U.S. Food and Drug Administration, live streamed around the world for the first time this year
• Exhibit Hall, featuring 60 industry leaders and the top products and services in CDM
• DDIA Reception, a night of food and fun recognizing the year’s best innovation in clinical data management(see more on this year’s winner later in this issue)
• Networking receptions, giving attendees the chance to strengthen existing partnerships and friendships while creating new ones

We hope you enjoyed this year’s conference and walked away with valuable information and connections that you will take with you well into the future.

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 Thank You, Sponsors!

We would like to thank our 2011 Annual Conference sponsors for their continuous support!

Diamond BioClinica Platinum Acceliant eClinical Solutions PharmaPros ReSearch Pharmaceutical Services TalentMine Gold Bronze CRF Health i3 Medidata Octagon

Silver Cmed Cognizant MaxisIT MedNet Solutions MERGE Healthcare OpenClinica Perceptive Informatics TATA Consultancy Services Bronze PharamaNet Study Manager Media Partners Applied Clinical Trials Institute for International Research Life Science Leader PharmaVOICE

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 Don’t Forget to Collect Education Credits

Conference attendees are eligible to earn continuing education units (CEUs) by successfully answering at least 3 out of 5 assessment questions for each session they attended at the Annual Conference. All questions are accessed through SCDM’s Online University website at this address: http://portal.scdm.org/quiz11.

Once at the site, login or create a username, password and profile if it is your first time on the site. Next, select the link "Click here to access the SCDM Annual Conference Assessments" and enter the enrollment key "scdm11". For each session, you are allowed two attempts to achieve a passing score. You may log in as many times as you need to take all of the relevant quizzes.

All assessments must be completed by November 30.

If you have any questions, please contact us at info@scdm.org.

 INC Research Wins 2011 Data Driven Innovation Award

An EDC solution from INC Research and Perceptive Informatics that followed 2700 trial subjects as they traveled from originating sites to participating sites in a destination country, and then returned home for end-of-study visits, is the recipient of the Society for Clinical Data Management’s 2011 Data Driven Innovation Award.

This multi-site study presented challenges that were not possible to accommodate in a typical EDC system. Site/casebook accessibility to meet these special needs challenged the EDC system hierarchy whereby subjects belong to only one site. Requirements of the study included:

• The destination country site was not identified until the subject actually visited the site, and the subject could attend visits at different sites while travelling. Site staff needed access to the subject’s casebook within minutes of attending a visit.
• A subject’s casebook needed to be accessible by all the sites the subject visited, but sites could not view casebooks that did not belong to one of their own subjects.
• Casebooks had to support multiple levels of access at the item level. Sites could enter data applicable to the visit, and could see but not change data entered by another site unless the data was a concomitant medication or adverse event follow-up.

INC Research implemented a solution that included a casebook design and a web-based bridge between TriaLine IWR (an INC Research proprietary system) and Perceptive Informatics Datalabs® EDC. This bridge assigned users to a subject casebook within minutes of a subject attending a visit and then controlled access to the casebook from the point of randomization to the end-of-study visit.

This solution allowed data management to be able to review and query clinical data to each of the sites with minimal confusion. It also provided real-time information to each subject’s progress in the study, with respect to visit locations as well as adverse event and other safety data.

The automated processes introduced by the web bridge also freed up the clinical data manager from coordinating access requests and transfer of data between originating and destination country sites. This automation of a previously manual process eliminated user errors, which can cause delays in data entry for a subject.

“We are honored to receive this prestigious award from SCDM, an organization dedicated to promoting quality and excellence in clinical data management,” said Tara Fitzgerald, Senior Vice President, Global Services, INC Research. “Winning this award recognizes the innovation, creativity and zeal that our INC Research team delivers on behalf of our customers every day to accelerate the development of life-saving and life-enhancing therapies for patients worldwide.”

The Data Driven Innovation Award was created to recognize the best advancements in clinical data management technology or service. There were 16 entries for the 2011 award, the most in its five-year history. Five finalists, selected prior to the Annual Conference, demonstrated their products to a judging panel composed of Certified Clinical Data Managers to determine a winner. INC Research was announced as this year’s winner at the DDIA Reception in Baltimore, MD on September 12 in conjunction with the 2011 SCDM Annual Conference. 

We congratulate INC Research on their win and also extend a sincere thank you to this year’s panel of judges:

• Susan Hale, CCDM
• Bill Litzenberg, CCDM
• Leigh Smith, CCDM
• Teresa Taiclet, CCDM
• Guang L. Wang, CCDM

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 2011 SCDM Curriculum

2011 Professional Development Calendar
Online Course	Dates
Database Lock and Randomization	September 19 – October 14
Database Lock and Randomization	September 19 – October 14
Data Standards in Clinical Research	October 3 – November 5
Data Quality in Clinical Research	Begins October 30
2011 Webinar Schedule
Biostatistics – What Every Clinical Data Manager Should Know	September 22 & 29
Data Integration and the GCDMP: A New Chapter in Clinical Data Management	October 20
The Role of Metrics in Clinical Data Management: Tracking Quality and Efficiency	November 17

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 Thank You RPS and Conference Attendees for Making a Difference!

As you may have heard, this year’s SCDM Annual Conference offered attendees the chance to give back to our host city of Baltimore, MD by depositing $10.00 Donation Certificates into one of three charity boxes at the ReSearch Pharmaceutical Services, Inc. (RPS) booth in the exhibit hall. Three area organizations were represented and attendees allocated their donation certificates to the group of their choice. RPS then turned those certificates into real-dollar donations.

Your contributions made a difference for these three organizations:

• Baltimore Animal Rescue & Care Shelter, a local non-profit animal shelter
• First Candle, a non-profit working to prevent Stillbirth and Sudden Infant Death Syndrome (SIDS)
• House of Ruth, a domestic violence center for battered women and children

total of $4,005 was donated to the three organizations. The final amounts each charity received are listed below. We thank RPS for their generosity and we appreciate all of the conference attendees who participated. We hope to make this an Annual Conference tradition for years to come.

$1,410	$1,240	$1,355

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 Get to Know the CCDM®

SCDM is proud to introduce Shruti Tambe, Clinical Data Manager I, i3 Global, as a recipient of the Certified Clinical Data Manager designation.

Q:	Why did you become certified?
A:	I have 2.9 years experience in CDM and have learned a lot about CDM during those years. Since becoming a CCDM® is the highest professional designation for clinical data managers, I was very interested in being associated with the certification.
Q:	What challenges did you have taking and studying for the exam?
A:	The greatest challenge for me was determining what study materials to refer to. The exam covers a wide range of topics so narrowing down the list of sources from which to study was my biggest challenge.
Q:	How has being certified benefited you?
A:	This certification has encouraged me to participate in additional educational activities related to CDM. It has also boosted my confidence and my overall interest in CDM profession.
Q:	What materials did you use to study for the exam?
A:	Mainly I used the GCDMP, ICH GCP Guidelines - E6 and E9, some basic concepts of 21CRF-Part 11, Medical Coding, SAE reconciliation and External Data Handling.
Q:	Can you provide helpful hints for those interested in taking the certification exam?
A:	While performing daily activities such as Manual Reviews, Discrepancy Review, applying SECs to the database or performing reconciliation,pay attention to details. Thinking about things such as whether an SEC applies to some kind of obvious error or not, what kind of Manual checks are repeated commonly across studies, what kinds of checks (i.e. Univariate query/Multivariate query/Coding query) fire for a particular kind of inconsistency etc., proves very helpful while answering CCDM® exam questions. Draw on your experience as most of the questions are based on the CDM activities which Clinical Data Managers perform daily.
Q:	Any additional comments you would like to provide?
A:	There are many activities which we perform daily without actually thinking about their impact on the overall project management. Since the GCDMP covers the overview of all aspects of Data Management, taking the CCDM® course increases awareness of the contribution of our day to day activities to overall Project Management.