SCDM - Data Connections
Header - Data Connections
Header - Data Connections APRIL 2013
 

bullet Breaking News

arrow   Updates from the Board
arrow   Call for Board elections
arrow   Volunteer Opportunities: Join the Marketing Committee
arrow   Contribute to Data Basics
arrow   SCDM India Conference: Register now!
arrow   SCDM 2013 Annual Conference: Shape the Program!
arrow   SCDM Membership: 5 reasons to become a member

bullet CCDMs©

arrow   Industry Program
arrow   Get to know your CCDMs

bullet Partner Events

arrow   4th Proactive GCP Compliance
arrow   BioLogistics Summit

bullet Educational Opportunities

arrow   Educational Opportunities
arrow   2013 Online Course Schedule
arrow   2013 Webinar Schedule
arrow   GCDMP SME's Wanted

bullet News Updates

arrow  SCDM Member Recognition
arrow  How You Can Contact Us
Breaking News

 
Updates from the Board

Dear Readers,

Thanks for picking up your April issue of Data Connections. It’s hard to believe this is the start of 2nd quarter! Hopefully you have renewed your membership by now and started to peruse the revitalized structure of the SCDM committees and taskforces trying to decide how you might volunteer this year.

The Board of Trustees has been busy with plans for two very important and exciting upcoming conferences: The 1st Asia Conference in Mumbai (May 31-June 1) and the 19th Annual Conference in Chicago (September 10-13).

If you haven’t decided how you might contribute to furthering the discipline of CDM in the industry, you might consider submitting an abstract for consideration to the conference committee chairs for the Annual Conference. The call for abstracts has opened up on the SCDM website with all the detail and instruction for posting your <300-word abstract.

Abstracts are invited for the following sessions:

  • Best Practices for Managing and Processing Imaging Data in Your Clinical Trial
  • Metadata and Data Validation from Source to Submission: Tactics and Strategies
  • Medical Device Data Management: The Issues, Standardization, and the Future
  • Clinical Trials in the Cloud: A New Paradigm?
  • Third Party Data: Challenges in This New Electronic Era
  • Training the Next Generation of Clinical Data Managers: The Industry/Academia Interface
  • Project Management: Leading With Momentum: How to get it, maintain it and finish strong with itClinical Trial Networks: Opportunities and Challenges for Data Coordinating Centers
  • Clinical Trial Networks: Opportunities and Challenges for Data Coordinating Centers
  • Finding Harmony Between Quality and Quantity
  • Clinical Data Marts and Data Warehousing: New Models and Approaches
  • Data Management Remix: Different Tools, Techniques and Terminologies for Various Types of Studies
  • DM Global Outsourcing: Leaning, Leveraging, Best practices and Performance
  • Designing Patient-Focused Research to Maximize Product Success
  • eSource: Challenges, Opportunities, and Real-World Experiences

For details about becoming a member, various committee responsibilities, upcoming activities, or to learn more about our society in general, go online at www.scdm.org. If you are ready to submit your abstract, you can go directly to the Abstracts session of our website.

The deadline for submitting all abstracts is April 20th. The conference planning committee and session chairs are eagerly waiting to hear from you! This is a great opportunity to share what you know best.

I look forward to seeing you in Mumbai and Chicago.

Warmly,

Marysasser H. Holloway, CCDM
Secretary
Board of Trustees
SCDM

Back to top
 

 
Call for Board elections

Open to All SCDM members globally.

It is time to start thinking about running or nominating someone to run for the Board of Trustees.  Nominations are due by May 8, 2013Elections will be held in July & August. 

Newly elected Board members are expected to attend an orientation Board meeting held just prior to the SCDM Annual conference being held this year in Chicago, Illinois from September 10 to 13.  The term for these individuals will begin on January 1, 2014.

Candidates are required to be members of SCDM.  They may be located anywhere in the world.  Remember, our mission is:   Becoming the world’s leading advocate for the discipline of Clinical Data Management. Board members can be from CRO’s, consultant organizations, Academic Research, Pharma, Biotechs, and our vendor organizations. 

Board meetings are held four times a year.  The Board of Trustees meets at least four times a year.  Meetings may be virtual or face to face.  Attendance is mandated at these meetings.   Transportation and lodging for these meetings are the responsibility of each board member. 

Terms for the Trustees are for two years.  Multiple individuals may not be elected from the same corporation.  

The Board manages the affairs and business of the Society.  Meetings will cover many aspects of the governance of SCDM such as financial matters, relationships with other professional organizations, as well as certification and educational offers.

For more information, contact the SCDM Office for a Board of Trustees Fact Sheet and an application form.   If you would like to discuss confidentially, please send me an email at the following address:  Susan.K.Howard@gsk.com   I can arrange a meeting with you.

Susan Howard
Chair, Nominations Committee

Back to top
 

SCDM Volunteering Opportunities

SCDM’s vision to become the world’s leading advocate for the discipline of clinical data management is becoming a reality, thanks to members and volunteers that are driven and enthusiastic. We look forward to welcoming you to the SCDM Leadership!

This is your chance to be part of the team, to contribute to the SCDM mission and advance the clinical data management discipline across the globe.

PR/Marketing skills? Join the Marketing Committee!

The Society for Clinical Data Management Marketing Committee seeks volunteers interested in helping to increase the organization’s visibility in the community and in private and public sectors.

The SCDM Marketing & Communications Committee establishes an annual marketing/communications plan to promote SCDM programs, working in conjunction with other SCDM Committees and the Board of Trustees to identify marketing/communications opportunities consistent with SCDM priorities and goals.

From co-managing SCDM’s social networks to promoting SCDM’s activities at events, if you think you have got what it takes, do not hesitate to submit your application!

Grow SCDM Membership Globally : Join the SCDM Membership Committee

The Membership Committee is still looking for international members to contribute to expanding the SCDM Membership worldwide and increasing visibility of the SCDM membership globally. We invite all our members from outside of the US to submit their application and integrate the SCDM Membership Committee! *

Visit the Volunteers Opportunities page on our website to know more about ongoing opportunities**.

We invite all of you to submit your application to volunteers@scdm.org for consideration by the SCDM Nominating Committee. All applications should include:

  • Letter of motivation
  • Resume, including past volunteer experience (if applicable)
  • History of SCDM involvement (if applicable)

*Applications for other positions will be integrated to the SCDM Volunteer Recruitment Pipeline for future consideration. Please note that we are accepting only applications coming from current members at this time. To renew your membership or apply for new membership, please visit the SCDM website (www.scdm.org).

**SCDM is also looking for GCDMP SMEs on specific topics. Please refer to the related article in this issue of Data Connections

Back to top
 
Novella
 
 

Contribute to SCDM Data Basics

As qualified professionals, you deserve the opportunity to fully express your knowledge, and to do so in the right channels.

We have exactly what you need: a place for your articles in Data Basics.

Data Basics is SCDM's quarterly digital journal featuring peer-reviewed articles on key industry news and issues. We remind you that you have the opportunity to contribute to our publications with original quality articles in your field.

Whether you will address general principles, focus on the business needs, or think that not enough has been said on that CDM hot-topic, this is your chance to make a contribution to the debate.
We are always on the lookout for quality articles!

Should you wish to have your article featured in the Summer issue, please note that deadline is set on April 8th, 2013.

For more information, visit the submission guidelines for Data Basics section of our website. Please send your manuscripts and accompanying materials to info@scdm.org

Get your article featured in SCDM's Data Basics and earn CEUs!

Back to top
 

SCDM Asia Conference: Register now!

The first SCDM Asian conference is only two months away! Make sure to join us in Mumbai on 31 May – 1 June 2013 for a truly thought-provoking experience!

What makes this conference unique?

  • Pre-Meeting Workshops on Coding and Lean Six Sigma in CDM
  • Ms Paula Brown Stafford, one of the 10 top women in biotech*, to contribute as Key Note Speaker
  • A session on the growth of CDM in Asia and best practices for working across geographies
  • Forums (as well as an invitation only 'Leadership Forum'), workshops, and Q&A sessions
  • Students’ opportunities: a debate on CDM
  • Conference tour extensions – discover fabulous Mumbai

The conference will also provide partner companies a global stage to feature their innovations. Do check our website for more information on sponsorship opportunities.

Registration and Housing is now open!

For more details on conference venue and official accommodation hotel, The Lalit, visit our website.

Please contact the SCDM local office for more information scdmasia@mci-group.com

See you in May!

*according to leading biotech publication FierceBiotech, 2012.

Call for Abstracts

All abstracts need to be emailed to SCDMAsia@mci-group.com. Deadline for Abstract submission is 15th April 2013. Submission instructions are available on the SCDM website. Abstracts must be submitted and presented in English only. Original scientific material will be encouraged and preference will be given to recent and unpublished findings.

Abstracts are welcomed on the following topics:

  • Evolving Trends in Data Management
  • Standards and Transformational Initiatives impacting CDM
  • Outsourcing Strategies in CDM
  • Innovation and Technology in CDM
  • The Emerging Landscape of CDM
  • Driving efficiencies in CDM
  • CDM Talent Pool - Closing the Gap
  • Project Management in Data Management
  • Clinical Trials and Pharmacogenomics
  • Is the Data Manager changing the way Monitoring is done?

Submit your Abstract!

We look forward to your presence at the SCDM Asia Conference in Mumbai, India at The Lalit!

Please contact the SCDM local representative for more details.

Elizabeth Christy on +91 9967080020 or email: echristy@scdm.org

Back to top

SCDM 2013 Annual Conference: Shape the Program!

Join us for the 19th edition of the Society for Clinical Data Management Annual Conference, September 10-13 in Chicago, IL the world's largest education event for clinical data managers and related professionals.

An Innovative Approach for an Evolving Industry

In Chicago, attendees will explore what the SCDM community has identified as the industry’s hot topics –from Best Practices for Managing and Processing Imaging Data in Your Clinical Trial to the investigation of new trends and paradigms in Clinical Data Marts and Data Warehousing or Third Party Data.

In-depth sessions and debates will concentrate on new challenges and best practices in the Clinical Data Management industry, providing industry professionals with the practical, "real world" information they need.

For more information on the event, including topics, venue and registration start date, please visit the SCDM 2013 Annual Conference website: www.scdm2013.org or contact us at AnnualConference@scdm.org

We also invite our industry partners to take advantage of great sponsorship opportunities and exhibit booth space at the 2013 SCDM Annual Conference. If you are interested in exhibiting or becoming a sponsor please contact Julie Elfand (Jelfand@scdm.org).

Share Your Knowledge. Submit Your Abstract!

Make this experience unique for yourself and for everyone else.

Our goal is to provide our attendees with a must-attend interactive conference, focusing on today’s challenges, and providing thought-provoking, relevant information.

Abstracts may only be submitted electronically by visiting the Abstracts session of our website.

Back to top
 
 
 

SCDM Membership: 5 reasons to become a member

We can think of at least five good reasons why you should sign up for SCDM Membership.

1. Attend two of 2013’s most awaited conferences in the Clinical Data Management world –for less
SCDM’s network&learn opportunities double this year with the Society’s first conference outside the US –and with the Member Discount, you can truly make the most of it. Join us for both our Annual Conference in Chicago (September, 10-13) and our 2013 India conference (Mumbai, May 31st and June, 1st).

2. Data Basics Spring and Summer issue
Data Basics, SCDM's members-only quarterly digital journal, out on March 26th and June 17th with articles that are borderline ground-breaking.

3. Save on SCDM’s rich Spring training program
Learn smart thanks to the Membership Discount. Starting on March 18th, upgrade your CDM skills with our elaborate educational catalogue, featuring five Online Courses, three Webinars, and many other opportunities.

4. GCDMP unlimited access
Have the Good Clinical Data Management Practices (SCDM's award-winning best practices for data management) at your fingertips.

5. Take Action! Committees are looking for volunteers
This is your chance to be part of the team and advance the clinical data management discipline across the globe.

Apply and make a difference!

Opportunities to learn, to come together with a community that is lively, dedicated and hungry for knowledge. Opportunities to discuss, to evolve, and shape the future of our organization and our industry.

This is SCDM. And we look forward to having you on board.

Back to top
 

Educational Opportunities

E-Learning to Fit Your Schedule

 
SCDM University

Data Quality in Clinical Research

Online Learning Course/1.6 CEU’s
April 22 - May 19

APRIL 3rd LIVE Course information session

Meet presenters Reza Rostami and Denise Redkar-Brown, and discover more about this online course before you register.

Contact us at info@scdm.org to attend the information session

Overview
This course will provide you with insights, tools and new skills development to control quality in clinical data management.

Over four weeks, the course will address general principles, best practices and issues in data quality management.

This four-week asynchronous course combines self-study and instructor-led lessons. Participants complete one module per week, moving through the course as a group, including contribution to asynchronous discussions.

Modules include: Defining Poor Data Quality and Understanding Its Impact, Outlier & Discrepancy Identification and Handling, Planning and Conducting Database Audits and Responding to Database Audits.

Click here for more information or to sign up now!

Back to top
 
SCDM University

Developing Data Management Plans

Online Learning Course/1.6 CEU’s
May 6 – June 9

Overview
This five-week asynchronous course combines self-study and instructor-led lessons. Participants complete one module per week, moving through the course as a group, including contribution to asynchronous discussions. Projects have deadlines according to a predetermined schedule.

The course will review documentation requirements and common practices and include examples and exercises using a fully developed training protocol. Online group discussions will be facilitated to benefit from common experiences and practices across organizations.

What You'll Learn
Participants completing the training should be able to accomplish the following objectives:

  • Define key elements in a Data Management Plan
  • Gather and organize the information describing the data handling processes used for a clinical trial
  • Describe workflow for electronic and paper data capture, quality control and related data processing procedures and metrics
  • Discuss clinical data management documentation requirements and rationale
  • Apply standards for creating, approving and maintaining Data Management Plans

Click here for more information or to sign up now!

Back to top

2013 Online Course Schedule

Online Courses Dates
Data Quality in Clinical Research 22 April - 19 May
Developing Data Management Plans 06 May - 09 June
Project Management for the Data Manager 03 June - 30 June
SAE Reconciliation, Safety Review and Coding 24 June - 21 July
Locking the Electonic Data Capture (EDC) System 15 July - 11 August
Processing Lab Data 30 September - 03 November
Database Lock and Randomization 14 October - 10 November
CRF Design 04 November - 08 December
Back to top

2013 Webinar Schedule

Webinar Dates
FDA Update April 18
Pharmacovigilance – Safety in Clinical Trials May 16
Database Lock – Closing the Deal June 20 & 27
CDISC August 29
Regulation around the World October 17 & 24
Risk-based Quality Management November 21

With members around the world, we understand it may be challenging for you to attend one of our live webinars. Don't worry- we've got you covered. All SCDM webinars are available On-Demand for you to watch at your convenience! Don’t miss out on these valuable professional development opportunities. Check out our webinar archives.

Back to top

GCDMP SME's Wanted

gcdmpOpportunity for GCDMP Volunteers:
SCDM is looking for Subject Matter Experts (SME's) to work on the following chapters: Medical Devices, EDC and Detecting Fraud
Requirements for SME's include:

  • A minimum of 6 years in the field of data management with 3-5 years of direct experience with the topic for which they are to be considered experts.
  • 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.
  • Available time needed to serve in the capacity of SME for this project, which is estimated to be approximately 25-30 hours over the course of the assignment (approximately 8.5 months).

An example of the breakdown for chapters being developed and written for the first time is:

  • Approximately twelve (12) hours to independently prepare an outline, identify the authorities that affect the topic, and compile the content
  • Approximately five to six (5-6) hours to independently review and comment on the chapter after drafting and editing by SP
  • Approximately six (6) conference calls conducted during normal business hours, each of which could last as long as one hour
Work will begin once the required number of SMEs is identified and will continue until the chapter is complete. If you are interested in becoming a Subject Matter Expert please send your qualifications along with a CV and the chapter title you are interested in to Dorothy Henry via e-mail info@scdm.org
Back to top

banner
 
Get to know your CCDMs  

CCDMs© Industry Partners Program

CCDMBecome a CCDM Industry Partner

The Society for Clinical Data Management CCDM® Industry Partner Program recognizes companies committed to quality clinical data management and Certified Clinical Data Manager (CCDM®) credentialing.

To qualify, companies must meet one of the following criteria:

  • At least 25% of CDMs are CCDMs
  • At least 10 CCDMs

Qualifying companies can display the CCDM® Industry Partner Program logo on their website, recruitment materials and marketing materials, and will be recognized by SCDM throughout the year online, in print and at events.

Certified Clinical Data Managers have met requirements of education and experience and have passed an exam testing key competency areas in CDM. CCDM credentials must be maintained by fulfilling renewal requirements every three years.

To get started, complete the application form.

 
Back to top
 

Get to know your CCDMs©

As you all know, the Certified Clinical Data Manager (CCDM) program identifies credible, trained, qualified professionals in data management. Facing this rigorous examination is no light challenge. Get to know your CCDMs© brings to you SCDM’s Certified Clinical Data Managers, with their stories, their opinions, and their suggestions.

Are you a brand new CCDM©? Or have you renewed your certification in the last two months? Then you most definitely are Get to know your CCDMs©material! Do you want to be featured in the next issue of Data Connections, or to simply give us some feedback on your experiences as a CCDM? Contact Ingke at IWiese@scdm.org .

Back to top
Partner Events  

 
4th Proactive GCP Compliance - April 10, 2013 - April 12, 2013

 4th GCP continues to act as the only annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss practical strategies to achieve and maintain global GCP compliance.

 

 

BioLogistics Summit - June 3-5, 2013

The BioLogistics summit will tackle the key challenges associated with the handling, storing, manufacturing and distribution of biologics.

The Summit includes:

  • 20+ Industry Experts
  • 3 Interactive Workshops
  • 11 Networking Round Tables
  • 2 Breakout Tracks: Clinical Logistics and Biological Materials

For a copy of the program or more information email taryn.soltysiak@iqpc.com

Back to top
News Updates  

 
Submit Your News

Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to info@scdm.org

Partnership Opportunities

SCDM offers a wide range of opprutnities to the companies who want to position themselves as the supporter of Clinical Data Managers worldwide. Whether you choose to advertise in our publications (Data Basics or Data Connections) or to be associated with our education services (online courses, webinars), SCDM will make sure to provide you with the visibility that you need.

We also invite our industry partners to take advantage of sponsorship opportunities and exhibit booth space at the 2013 SCDM Annual Conference.

For more information please visit http://www.scdm.org or contact Julie Elfand – Sales Manager – Annual Conference & Advertising or Lisette Werbowetzki, Sales Manager – Webinars & E-Courses.

Back to top

SCDM Welcomed these NEW Members in March 2013!

Alia Leslie
Alicia Green
Allison Hale
Amy Roberts
Amy Walsh
Arundhati Topkar
Ashley Scott
Brian Cooley
Carolyn Malloy
Christine Barnes
Cindy Zhang
Claude Price
Corinne Symonds
David Hitt
David Main
David Appleby
Derek Petersen
Devendra Katkar
Dipti Mohanty
Erica Sage
Fay Robinson
Frank Beddia
Franklin Butler
Gena Rodriguez
Grant Cruchley
Helene Laniel
Hsiu-yin Hsiao
Hugo Arroyo Figueroa
James Dickson
Jaspal Poonian
Jerome Sink
Jessica Sniffen
Jonathan Abraham
Judy Villafranca
Julia Chung
Julie Kay Rogers
Jung-Hye (Jennifer) Moon
Kathleen GriffinSmit
Kathryn Jenkins
Kathryn Odian
Kathy Bodri
Kay Lynn Thomas
Kelli Ulrich
Kelly Sclavounos
Kendal Benza
Kenji Nagaya
Kenneth Learn
Kim Vrobel
Kimberly Dukes
Kimberly Lapen
Kirwyn Sutherland
Krupa Parekh
Lance Kupka
Laura Smith
LaurenK Showe
Lisa Dean
Mackenzie Learn
Marc Levine
Margaret Penn
Maria Fassano
Mary Catlette
Megan DeLuca
Melvia Sykes
Meredith Moore
Meri Rozenshteyn
Michael Scholz
Michele Oehling
Molly Hunt
Monica Johnson
Natalia Bialas
Nerolie Stickland
Nitin Raut
Paul Glaister
Pooja Clayton
Quatia Watkins
Ricardo Azedo
Robert Jacobs
Rupali Pawar
Sanika Sawant
Sanjay Mishra
Sarah Lilly
Sharon Nason
Shen Zhong
Simona Ryabo
Sonali Nabar
Stephanie Allen
Sue Fidora
Sunil Joseph
Susan Vigen
Tina Sinnett
Tonya Arthur
Travis Baker
Veronica Eufemia Renones
Vishal Karande
Vivian Bennewitz
Wayne DellaMaestra
Back to top

SCDM Congratulates the Following Members for Entering Their 5th Year of Membership in March 2013!

Barbara Mathewson
Charles Yan
Daniel Jeffers
Henry Friend
Ilonka Evans
Jaime Altamirano
Jasna Grujic-Ciric
Joanne Nagel
Karen Whitson
Kelly Shart
Lee Ann Liss
Nicholas McWilliams
Rachel Feast
Ravindre Panchia
Rey Wong
Sue Chan
Tabassum Hoda
Thomas Mullinax
Victoria Johnson
Back to top

SCDM Congratulates the Following Members for Entering Their 10th Year of Membership in March 2013!

Brad Cohen
Cheryl Garner
Helen Hall
Jennifer Taylor
Karen Bird
Mauro Montanari
Back to top

SCDM Global HQ

Géraldine Damar
Executive Director
Gdamar@scdm.org
Ingke Wiese
Operations Manager
iwiese@scdm.org
Lysan Drabon
Membership manager
ldrabon@scdm.org
Dorothy Henry
Educational Projects Manager
dhenry@scdm.org
Hannah Skilling
Membership & Customer Service Administrator
Info@scdm.org
Giulia Vettore
Marketing & Communication Coordinator
Gvettore@scdm.org

SCDM North America Office

Matthew Jones
North American Operations Director
mjones@scdm.org
Julie Elfand
Sales Manager
jelfand@scdm.org
Janet Huynh
Community Coordinator
jhuynh@scdm.org
Alphonsus Baggett
Community Coordinator
abaggett@scdm.org
Lisette Werbowetzki
Membership Coordinator
lwerbowetzki@scdm.org

SCDM India Office

Elizabeth Christy
Indian Operations Manager
membership-IN@scdm.org

Join the community for our news and updates!

facebook  linkedIn  Twitter

Back to top
Global Headquarters
Society for Clinical Data Management, Inc

300 Avenue de Tervueren
B-1150 Brussels, Belgium
Tel: +32-2-740.22.37
Fax: +32-2-743.15.50
info-hq@scdm.org
North America Office
Society for Clinical Data Management, Inc

1444 I Street, NW, Suite 700
Washington DC, 20005, USA
Tel: +1-202-712.9023
Fax: +1-202- 216.9646
info-am@scdm.org
India Office Society for Clinical Data Management
MCI Management India (P) Ltd.
203, Wing B, Citipoint
(Near Hotel Kohinoor Continental)
J. B. Nagar, Andheri-Kurla Road
Andheri (East). Mumbai – 400059
info-in@scdm.org

You have received this message because you have had previous contact with the Society for Clinical Data Management.
If you do not wish to be included in our mailing list, please click here.