Handling Laboratory Data
February 25 - Noon EST
60-minute presentation followed by 30-minute Q&A
Overview
Laboratory data collected in a clinical trial can represent both safety and efficacy data. Understanding some basic laboratory terminology as it applies to typical lab testing can facilitate understanding the protocol, designing the CRF and defining data review standards. The terminology is applicable to data collected locally at each site or centrally processed by a single vendor. The accuracy and integrity of lab data is critical to the statistical analysis of trial data.
Outcomes
- Identify lab requirements detailed within a protocol
- Describe the common categories of laboratory testing
- Assess CRF design requirements for required tests
- Apply data review standards to Laboratory data
For further information and to register please click here.
Be a presenter at the SCDM Annual Conference
SCDM is now accepting abstracts for presentation at the 2010 SCDM Annual Conference, October 17-20 in Minneapolis, MN. This is your opportunity to share your knowledge and best practices with the largest audience of clinical data management professionals.
The Annual Conference planning taskforce will select a diverse field of speakers, representing viewpoints from pharmaceutical, biotech, medical device trials at sponsor companies and contract research organizations.
Abstracts are due March 29. Download the Call for Abstracts now and start preparing your proposal. The 2010 Annual Conference program will consist of two tracks of concurrent sessions - one track for intermediate audiences; one for advanced. Generally, each session consists of three 20-minute presentations, 15 minutes for questions and five minutes for discussion.
Suggested presentation topics include:
- Cleaning Electronic Data
- SOP Philosophies and Management
- Effective CDM Training in the 21st Century
- Value During the Clinical Development Plan
- Unique Challenges for CDM in Oncology Studies
- Project Management in CDM - Advanced Topics
For a complete listing of suggested topics, including information on how to submit an abstract, view the Call for Abstracts. View complete Annual Conference details at www.scdm.org.
Questions? Please contact SCDM at 414.226.0362 or info@scdm.org.
| 2010 Professional Development Calendar | |
| 2010 Online Course Offerings | |
| Program | Begins |
| CRF Design | March 28, 2010 |
| Query Processing and Tracking/Database Updates | May 9, 2010 |
| Metrics and Identifying Data Trends | June 13, 2010 |
| SAE Reconciliation, Safety Review and Coding | July 25, 2010 |
| Managing Lab Data | September 5, 2010 |
| Database Lock and Randomization | October 10, 2010 |
| Project Management for the Clinical Data Manager | November 7, 2010 |
| 2010 Webinar Schedule | |
| Handling Laboratory Data | February 25, 2010 |
| Strategies for Coding Oncology Trial Data | March 18 & 25, 2010 |
| Managing Virtual Teams | April 22, 2010 |
| Data Management Plans | May 20, 2010 |
| Overall Clinical Trials Process, Roles and Responsibilities | June 17 & 24, 2010 |
| Protocol Review | August 12 & 19, 2010 |
| Touch Point/Hand offs (with SAE Reconciliation) Webinar | September 16 & 23, 2010 |
| CDISC | November 11 & 18, 2010 |
Credit-Earning OpportunitiesThat Suit You Live Webinars For further information contact info@scdm.org |
Survey What topics would you like to see addressed in future online courses? Click here to take the survey. |
Do not let your Certification Expire
The Certified Clinical Data Manager status is valid for three years before requiring renewal. By renewing, CCDM®s demonstrate their willingness to continue to advance within the field as well as their commitment to continued growth in knowledge and competency in clinical data management.
In order to renew, CCDM®s may either retake and pass the current version of the CCDM exam, or obtain 1.8 Continuing Education Units (CEUs) which is equivalent to 18 contact hours, in accordance with the CEU chart. These hours can be earned through attendance at professional development events such as SCDM webinars, workshops, and Annual Conference sessions; participation in taskforce work; or taking leadership positions on SCDM taskforces.
The 1.8 CEUs/Participation Credits must be earned within three years. This time frame begins on the date of certification. Individual CEUs and Participation Credit listings are available in the member's only section of the website at: https://www.scdm.org/members/ceu.asp.
If you have any questions, please contact Sue Abrahms at sabrahms@scdm.org.
Eight GCDMP Chapters Released
Four revised and four new GCDMP chapters were released in 2009. The revised chapters are Data Privacy, Database Validation, Programming and Standards, Data Entry Processes, and Medical Coding Dictionary Management and Maintenance. Data Management Standards in Clinical Research, Edit Check Design Principles, Laboratory Data Handling and Patient- Reported Outcomes complete the new chapters. This work was accomplished with the help of Subject Matter Experts listed below who contributed significant time and talent. Ongoing updates to the GCDMP are an important SCDM initiative given its acceptance as a fundamental resource and reference by the global CDM community.
|
Alexis Gianelos, CCDM Annette Travalent Bridgette King Carmel Scharenbroich Carolyn Lozier Cheryl Maslanka-Uken Cheryl Simon, CCDM Connie Krause Dan Crawford Dawn Kaminski Debra Klein Donna Medeiros Ed Kellar Eileen Monge Geraldine Lamkin, CCDM Henry Chen Hieu Ly Joseph Pokorny, CCDM Katherine Mortali Straub, CCDM Kimberly Miller Laura Fazio, CCDM Len Grunbaum |
Lisa Nastari Lori Poole Lynda Hunter, CCDM Marysasser Hedrick Holloway, CCDM Melissa Lamb Michele Goldstein Nadia Matchum, CCDM Nina Maris Olivia Montano-Tritz, CCDM Pati Stone, CCDM Paul Ackermann Paul Rutti Petrolene Le Roux, CCDM Rhonda Facile Robert Stemplinger Shannon Labout, CCDM Sunil Gupta Susan Howard Suzanne Lamerand Teresa Ancukiewicz, CCDM Timothy Peters, CC Urmi Parkar |
Enjoy Reading Data Basics?
Now is Your Chance to Contribute to the Next Issue!
| Issue | Topic | Submission Deadline |
| Spring | Reaching Across the Organizational Divide | 2/10/2010 |
| Summer | Virtual Teams/Project Management | 4/6/2010 |
| Fall | Data Quality | 7/6/2010 |
| Winter | Pharmacogenetics and Metabolomics | 10/5/2010 |
This is an excellent opportunity to earn SCDM participation credits toward certification renewal.
Please contact Sue Abrahms at sabrahms@scdm.org for additional information or click here.
SME's Wanted
WANTED! Short-Term SCDM-GCDMP Volunteers:
Subject Matter Experts needed to review the next Good Clinical Data Management Practices (GCDMP) chapters scheduled for revision.
SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Protocol Review, Safety Data Management and Reporting, Data Integration, Preparing For and Surviving an Audit, Data Storage and Detecting Fraud.
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.
Join the Conversation on the "DataMatters" Listserv - 379 Members Strong and Growing!
"I am seeking information on how others are handling study subject identification, especially if both a unique number and a secondary identifier such as an alphabetic code are used. In the past, patient initials were often used to provide a second identifier which was intuitive at clinical sites, but that scenario presents challenges with HIPAA. I would appreciate information on how this is addressed by others and if a second identifier is used then how it is obtained."
"What error rate do you typically define as acceptable in an audit of a database?"
The SCDM listserv "DataMatters" is an online dialogue among members and others with common interests and experience in clinical data management. Through the listserv, discussions form around ongoing, focused CDM concerns, with individual subscribers contributing or listening in on news, policies, practices, questions and solutions. Listservs are driven by member interest and energy. They are self-subscribed and are open to both members and non-members to encourage a wide involvement of interested professionals.
To subscribe, please follow the link below and complete the form under "Subscribing to DataMatters". You will then receive a confirmation email with instructions to complete the confirmation process. Upon approval from SCDM staff, you will then become a member of the Listserv.
Subscribe now and see what we're talking about!
BoT Update®
In our first Board of Trustees meeting of 2010, January 18-19, we had a full agenda covering what we accomplished in 2009 and what needs to be accomplished in 2010 and beyond. We reviewed our strategic objectives and partnerships to make sure they were in line with the industry trends and would bring the most value to our membership. We approved our 2010 budget and worked with our newly formed Finance Committee to make sure we are acting to keep us financially strong in these tough economic times. We launched our first multi-year marketing plan that will be unveiled to our committee chairs and volunteers later this year. The committee chairs presented their 2010 project plans, which included new educational offerings, new GCDMP chapters and new projects to explore cutting-edge trends in our industry.
With that in mind, I want to thank all of our valued members who will volunteer this year. We could not have accomplished so much in 2009, and have such ambitious plans for 2010, without you. You are the backbone of this society and, on behalf of the entire Board, we thank you for all of your efforts and sacrifices.
2010 will be a great year for SCDM. I invite you all to join us on this journey by volunteering your time and talents. Contact us at volunteers@scdm.org if you are interested.
John C. Estrada, CCDM
SCDM Board of Trustees
Get to Know the CCDM®
SCDM is proud to introduce Brad Cohen, as a recipient of the Certified Clinical Data Manager designation. Brad is a Senior Data Analyst with PharmaNet in Blue Bell, PA.
| Q: | Why did you become certified? |
| A: | I became CCDM certified because I wanted my company and clients to recognize my level of understanding in Data Management. The CCDM certification complements my ten years of experience in the industry.
|
| Q: | What challenges did you have taking and studying for the exam? |
| A: | When I took the exam, the material was being updated and the exam format changed from 3-sections to one. Despite the changes, I was well-prepared for the exam and I passed.
|
| Q: | How has being certified benefited you? |
| A: | I feel that my colleagues have gained a better respect for me and my abilities as a Data Manager. In addition, I have built on my CCDM certification by attending SCDM classes that are offered at my company.
|
| Q: | What materials did you use to study for the exam? |
| A: |
I reviewed all study materials provided by SCDM on their website. In addition, I referenced the ICH and 21CFR Guidelines where appropriate. |
| Q: | Can you provide helpful hints for those interested in taking the certification exam? |
| A: |
Please refer to your real-life experience in Clinical Research. I found that through personal experience as a Lead Data Manager, I was able to successfully answer a lot of the exam questions.
|
| Q: | Any additional comments you would like to provide? |
| A: |
I want to thank SCDM for developing a CCDM program. The certification will help me in my career. In addition, I look forward to attending additional SCDM classes in the near future.
|
Share your professional accomplishments with your peers. Submit your promotions, article publications, industry recognitions and other news to Sue Abrahms at sabrahms@scdm.org.
SCDM welcomed these NEW members in December 2009!
|
Kristin Alexander, BA BS Rachel Alkhas, BS Vinnie Almase Thomas Angelius Olivia Brown, BS Judy Chang Timothy Connolly, BA Sriraman Devarajan, B.Comm Annmarie Earnhardt, MBA, RN Lance Grove, ARRT Jessica Guider Madhura Gurjar Thejas Swarup A. Kethini Charan Kumar, MSc Polyxenos Lithotomos, BS Avelino Loquere, Jr., RN, MD, CCRC, CCRP Debora Manuel, BS |
Jennifer McGill, BA Bineesh Mekalampatta, CCDM Laura Pearce, BSc Elina Podvalny, NS Marianne Rahme, BA Gitanjali Rajamani, BS, MBA Priyabrata Sahoo, MBA Latika Sharma, MD Ellen Sondermann, RN Samuel Su, MS Kerry Tanwar, BA Susan L. Thayer, MS, CCDM Erik Van Widenfelt, BS Sofie Vande Velde, MSc Sebastian Varghese, MA, MBA Joe Warlow, MS Mark Williams, BS Jennifer Yee, BA |
SCDM congratulates the following members for entering
their 5th year of membership in December 2009!
|
Valerie Acers Cynthia Baxter, CCDM Marcia Brackman, BA, CCDM Beth Cabage, RN, BSN, CCDM Anastasia Derzko-Taskovski, HonBSc, MPH Stacie Grinnon, PhD |
Marcia McKenna, CCDM Anastasia Nguyen Mats Persson, BA Karen J. Powell Suma Suresh, CCDM Rutika Vara, MBA |
SCDM congratulates the following members for entering
their 10th year of membership in December 2009!
Imad Omar, BS
Ellen Randoll
Carmel M. Scharenbroich, MS
SCDM Members Receive Discounted Registration to Partnerships in Clinical Trials Event
Through a partnership with the Institute for International Research, SCDM members receive 25% off the cost of registration to the 19th Annual Partnerships in Clinical Trials conference, April 12-14 at the Orlando World Center Marriott in Orlando, FL.
Register online and enter code XPSCDM to receive the discounted registration rate. Only SCDM members qualify for this special rate.
About Partnerships in Clinical Trials
Partnerships with CROs is now known as Partnerships in Clinical Trials. After almost 20 years, the industry and the event have experienced tremendous growth as outsourcing to CROs and other clinical outsourcing providers has become more than a strategy to control costs and expedite clinical trials but the strategy for ensuring value and quality in complex clinical trials. The new title better reflects the comprehensive nature of the program, which is the must-attend annual event for clinical outsourcing and development professionals, and is increasingly valuable to those with responsibilities in clinical operations, drug safety and quality. Partnerships in Clinical Trials continues to be the leading global event serving the educational and business needs of pharmaceutical, biotech and medical device executives in the United States.
Visit www.clinicaltrialpartnerships.com for more information, or read the IIR blog or follow IIR on Twitter.
SCDM Members save $300 on CTMS Event
Find your management solution at the Center for Business Intelligence's 3rd Annual CTMS - Solutions for Leveraging CTMS Capabilities, Driving Efficient Integration and Implementing Effective Metrics and Reporting.
Save $300 on registration with code MCG334. Only SCDM members qualify for this discount.
Following two successful years of addressing the best practices in CTMS utilization, this year's conference focuses on industry case studies and collaboration. Seasoned and experienced representatives from Shire & Abbott review the highlights and lowlights of CTMS implementation, integration and execution, sharing best practices from their years of experience.
CBI's 3rd Annual CTMS is being held March 18-19 in Philadelphia. Visit the Web site at http://www.cbinet.com/ctms for more information.
