IMPORTANT ANNOUNCEMENTS
SCDM Leadership Forum
March 17-19, 2009
Nashville Marriott at Vanderbilt University
To all leaders in the CDM discipline,
SCDM invites you to participate in the 2009 Leadership Forum. This conference is becoming the principal forum for strategic discussions of interest to SCDM professionals. Over 90% of 2008 attendees indicated they plan to attend again this year or recommend a colleague participate . Below please find an overview of the agenda; we are sure you won't want to miss this meeting. Attendance is limited to ensure a personally valuable experience, so please plan ahead. Registration is open and available on the SCDM website.
SCDM is looking for a lively discussion on the tools and information necessary for a leader to successfully guide a CDM organization through changing times. Thus, the sessions have a general business / academic expert; as well as, industry expert leading each topic. The sessions are also divided into a primer at the onset, then a structured discussion deeply penetrating the selected topics, and finally smaller groups applying their knowledge in an interactive setting. The opportunity to reconnect with colleagues and leverage the knowledge of this group to refine your perspectives and strategy is an earmark of the Leadership Forum. We look forward to seeing you in Nashville.
Strategic Leadership in a Changing Environment
Keynote Presentations
The global business of clinical research is conducted within the complex environments of scientific discovery, healthcare information technology and regulatory oversight. Successful organizations may be measured by a variety of performance indicators, yet those often poorly capture an organizations capacity to sustain success or meet future needs. Effective strategic leadership results in organizational capacity to sustain success while routinely handling the environmental and operational challenges it is presented. Our keynote presenters will provide guidance on strategic leadership as well as navigating through change in the healthcare industry and CDM specifically.
The evening session will also include a report from the Society for Clinical Data Management's role supporting the FDA work to modernize clinical trials and the Clinical Trials Transformation Initiative (CTTI).
Risk Management
Organizations invest enormous resources ensuring decisions are based on sound information. Do you (and your staff) understand and make appropriate evaluations of risk as part of the routine decision making process? Organizational leaders are accountable for the risks associated with conducting clinical research and there is significant opportunity for CDM to greatly contribute to the overall risk management strategy. This session will highlight the risks as seen by our stakeholders and discuss methods to manage risk through the use of the clinical data resources available to us on every project.
Business Partnerships
Organizations rarely have the capacity to independently support all requirements that need to be fulfilled to conduct clinical research. Relationships with other organizations can provide expertise, resources or flexibility in meeting your scientific and business objectives. Whether this takes the shape of a preferred local staffing agency, a technology vendor, or globally outsourcing your operations the macroeconomic factors are only one angle. Focus will be placed on understanding your organizational business strategy from a CDM perspective and approaches to successfully building relationships with other organizations. Case examples will include both single point solutions and those that change the shape of an entire organization.
Organizational Leadership
Leadership and management are often used interchangeably, both in informal discussion and in governance models. The field of clinical data management and the requirements of scientific research are increasingly reliant on leadership in our field; however, this opportunity must be met by effectively filling those needs within an organization and developing future leaders from within the domain. In this changing environment effective leadership will need to hold a broader set of knowledge than expected of our management roles, including the forming effective work environments, understanding models of organizational behavior, job satisfaction factors, effective approaches to role definition and governance, staff development, and developing operational services that meet the needs of our stakeholders. This session will discuss how leaders can effectively ensure their business is designed for success.
SAVE THE DATE: Clinical Trials Abroad: Asia - Webinar Series
SCDM 2–part Webinar Series
November 13 and 20, 2008
11:00 a.m. - 12:30 p.m. Central time
Overview:
This webinar will address the knowledge and skills needed to conduct clinical trials overseas for data managers and will emphasize the Asian marketplace.
Target Audience:
Management level CDMs and those seeking advancement
Continuing Education Units:
SCDM will award continuing education units to participants who successfully complete each webinar. Assessment and post evaluation submissions are required.
CEUs available: .2 CEUs for each webinar, pending successful completion of assessments.
1 contact hour = .1 CEU
Society for Clinical Data Management
555 E. Wells, Suite 1100
Milwaukee, WI 53202-3823
sabrahms@scdm.org
Clinical Data Manager Certification reaches all time high.
The Society for Clinical Data Management (SCDM) announced it has certified a high of 330 clinical data managers. SCDM released version 2.0 of its Certified Clinical Data Manager (CCDM) exam worldwide through Prometric Testing Centers. The exam is the result of seventeen months and 2,000 volunteer and staff hours incorporating changes within the industry since the exam's first iteration in 2003. A team of experienced CCDMs wrote questions to assess competencies which were then subjected to rigorous technical and fairness reviews, as well as a review by an independent panel of industry experts. In June of 2008 over 200 candidates beta tested the exam before its final release.
Education resources are being developed to help candidates prepare for the new exam. An online course delivery system is also in development to offer exam preparation assistance as well as professional development and International Association for Continued Education (IACET) approved Continuing Education Credit (CEU) opportunities.
"The CCDM program further elevates the role of the Clinical Data Manager putting it on par with other pharmaceutical research professionals. The acceptance of the CCDM designation by our clinical colleagues has been phenomenal."
Angel Lazarov, CCDM, Director, Data Management, i3 Statprobe
To find out more about certification, call 414.226.0362 or email SCDM at info@scdm.org.
GCDMP - EDC Chapters Released
After a little over two years, SCDM is pleased to announce the finalization and release of three new EDC Chapters, covering study startup, conduct and closeout activities. These exciting new chapters provide the industry with a great resource for understanding how best to go about implementing, maintaining and closing out EDC based clinical data studies. With the contribution and help of many, this was a momentous effort. Each section was led by a team of subject matter experts. SCDM would like to acknowledge the leaders of these teams: Study Startup, Deb Jendrasek and Ralph Russo, CCDM; Study Conduct, Terri Hicks and Marco Van Doevern; Study Closeout, Jonathan Andrus, CCDM and Paul Clarkson, CCDM.
SCDM is sure that you will find great value in this chapter as you navigate the world of EDC.
These new chapters as well as the complete GCDMP is available at: http://www.scdm.org/gcdmp/
CCDM Industry Rewards Program
SCDM wants to reward your organization's commitment to hiring
Certified Clinical Data Managers!
As an organization that hires Clinical Data Managers, you know the added value that a Certified Clinical Data Manager (CCDM) brings. Through stringent testing, SCDM's certification program helps you identify exceptional talent in the CDM industry.
With the introduction of the CCDM Industry Rewards Program, SCDM will reward your commitment to excellence by recognizing the level of CCDMs in your organization. The best part is you can increase the benefits to your organization by increasing the percentage of CCDMs that you employ.
Here's how
SCDM will recognize you at the level you are at now and assign you rewards you can use in 2009. You can increase your rewards by encouraging certification of your CDMs or hiring CCDMs.
Reward levels are as follows:
| 1. CCDM Industry Partner | 10% of CDM employees have passed the CCDM examination |
| 2. CCDM Industry Leader | 25% of CDM employees have passed the CCDM examination |
| 3. CCDM Industry Champion | 50% of CDM employees have passed the CCDM examination |
| 4. CCDM Industry Master | 100% of CDM employees have passed the CCDM examination |
*The percentages are based on regular employees of an organization, contractors can not be counted.
Rewards:
CCDM Industry Partner
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference.
- Recognition during the annual conference business meeting.
CCDM Industry Leader
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- Recognition during the annual conference business meeting.
- A certificate will be provided to the organization recognizing their level at the annual conference
- One FREE certification exam for a non-certified CDM
- One FREE individual webinar registration
CCDM Industry Champion
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference
- Recognition during the annual conference business meeting
- One FREE certification exam for a non-certified CDM
- One FREE individual webinar registration
- One FREE Job Posting on the SCDM website
- One FREE banner advertisement (for one month) in Data Connections
CCDM Industry Master
- Organization recognition by level on the SCDM website
- Recognition in Data Basics and Data Connections
- Recognition in the annual conference program
- A booth identifier in the annual conference exhibit hall
- A certificate will be provided to the organization recognizing their level at the annual conference
- Recognition during the annual conference business meeting
- One FREE certification exam for a non-certified CDM
- Two FREE individual webinar registration
- One FREE Job Posting on the SCDM website (for a total of two)
- One FREE six month banner advertisement in Data Connections
- One FREE half page ad in the annual conference program
Data Driven Innovation Award Presented
Arrowhead Electronic Healthcare Wins SCDM Data Driven Innovation Award
In its second year, the Data Driven Innovation Award recognizes and honors excellence in the advancement of clinical data management and celebrates innovation in vendor/sponsor relationships. Three judges selected from the SCDM Certified Clinical Data Managers, unanimously agreed to honor the partnership between Arrowhead Electronic Healthcare and Bayer HealthCare Pharmaceuticals utilizing the "Dumb Monkey", an eDiary automated testing and documentation product.
Three finalists competed for the second annual award, as part of the 2008 SCDM Annual Conference. The second place award recognized the partnership between DSG, Inc. and Human Genome Sciences, Inc (HGS), Clinical Data Quality Control (CDQC) Checklist" that combines both system data and user enterable data to assess the status of "cleanliness" for a given project. This solution also provides metrics on data management and monitoring activities for each study that further enabled HGS to improve overall data management operations. Phoenix Data Systems' partnership with Kyowa Pharmaceuticals Inc. received the third place award for their solution that uses pre-programmed logic to assign Toxicity grading, ensure that only IRB approved sites were able to view forms associated with a protocol amendment, and dynamically control which data was collected based on previously entered data.
"We were extremely pleased at the quality of the applicants for this award and look forward to continuing to recognize these types of partnerships at our 2009 meeting," said Ralph Russo (Assistant Director, Global Clinical Data Management, Schering-Plough Research Institute), SCDM Fall Conference Co-Chair.
EDUCATIONAL OPPORTUNITIES
Archived Webinar
If you missed the free live presentation on October 15, 2008, you can view the recording to assist you as you prepare for the Certified Clinical Data Manager Exam.
Preparing for the CCDM Exam: an Insider's View
- Why be certified?
- Setting up the appointment
- Notification of results
- Logistics on exam day
- Test taking strategies
- Preparation resources
- Forming a study group
Contact Sue Abrahms at sabrahms@scdm.org for more information.
2008 Webinars Available on SCDM Website
If you missed one or several of the popular and highly rated SCDM sponsored webinars this year, you're in luck. You'll find them archived on the SCDM website and available for viewing. You can even earn CEU's toward recertification if you are already a CCDM by successfully completing the brief multiple choice quiz that accompanies each webinar.
These webinars consistently received high marks by attendees for professionalism, length and satisfying the expectations of viewers, with the majority of ratings at or above 90%. Here's a quick review of the past four offerings. For a more detailed description, go to the SCDM website at http://www.scdm.org/events/webinars/archive/
Coding (offered 11/8/07 & 12/6/07)
This series of two webinars addresses Coding Conventions and Best Practices, as well as Coding Dictionaries: a Look at MedDRA and WHO Drug is aimed at a cross-section of Clinical Trial and Data Management professionals including: CDMs, Biostatisticians, Clinical Scientists, Coding Specialists and Drug Safety Representatives.
Introduction to CDASH (offered 4/10/08 & 4/17/08)
Webinar #1 focuses on the basic data collection fields for CDASH Packages 1 and 2 (Adverse Events, Concomitant Medication, Demographics and Subject Characteristics, Inclusion/Exclusion Criteria, Medical History, Substance Use, Physical Exam and vital Signs). Webinar #2 focuses on the basic data collection fields for CDASH packages 3 and 4 (Drug Accountability, Exposure, Comments, Protocol Deviations, Disposition, Lab and ECG). Both conclude with a presentation on the practical implementation of CDASH recommendations and are aimed at a cross-section of Clinical Trial and Data Management professionals interested in obtaining a better understanding of CDASH.
Data Quality (offered 6/5/08 & 6/19/08)
This series addresses aligning DQ practices with Critical Path risk-based philosophies, and new approaches for DM to measure and control DQ, including statistical process control and trend analyses. The first webinar specifically covers best practices for defining and measuring data quality, while the second webinar is an advanced approach to DQ including data cleaning using trend recognition and statistical process control. Both programs are directed to data managers, managers of data groups, quality control and quality assurance statisticians, and project managers with higher experience levels.
Data Acquisitions (offered 7/23/08)
This webinar provides an introduction to data collection and data management practices with a focus on cancer research for Data Managers, Project Managers and other project team members working with cancer research data. Featured speaker is Liz Ness, director of staff development at the National Cancer Institute's Center for Cancer Research.
To access any of the series listed here, go to http://www.scdm.org/events/webinars/archive/
"DataMatters" Listserv Grows in Popularity
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.
The number of subscribers continues to grow. 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.
http://www.scdm.org/datamatters
Call for Articles Data Basics
Enjoy reading Data Basics? Now is your chance to contribute to the next issue!
| Issue | Topic | Submission Deadline |
| Winter 2008: | CDISC/CDASH/STDM and Other Standards | November 7, 2008 |
This is a wonderful opportunity to earn SCDM participation credits toward certification renewal.
Please contact Sue Abrahms at sabrahms@scdm.org for submission requirements.
SCDM CLASSIFIEDS
The DIA 9th Conference on European Electronic Document Management
December 3-5, 2008 - Hilton Barcelona
During the past decades we dreamed, anticipated, waited for a future time when technology would shape a new landscape for EDM. Many of the components have been around for quite a long time. Others are just emerging. But now, for the first time, that future has come to being. EDM in many different shapes, spanning from home-grown systems to hosted repositories, has become the established method for managing official documentation. Registration dossiers are built electronically even for paper submissions and safety information is exchanged in electronic formats. Is this the end of the story? Certainly not but this much is certain: the future we dreamed of then, is now.
Target Audience:
- Document and eRecords Managers
- Standards Implementation Specialists and Associates
- Quality Assurance and Compliance Professionals
- Medical Writers
- IT and Support Personnel
- Contract Researchers and Service Support Providers
- Regulatory Affairs / Operations Professionals
- Academic Researchers
- Regulatory Authority Representatives
- Validation Professionals
- Pharmacovigilance Professionals
- Knowledge / IP Professionals
Learning Objectives:
At the conclusion of this conference, participants should be able to:
- Have gained better understanding of transitioning to eSub
- Understand the principles of best practises in eCTD in MRP/DCP
- Explain the different practices and tools used by different industry sectors
- Understand the various regulatory perspectives
Pre-Conference Tutorials: December 3, 2008
Tutorial 1: A Document Management Practicum: Ideas To Improve And Enhance Your Journey
Tutorial 2: eCTD Implementation
Event Code: 08106
The DIA Europe Customer Services Team will be pleased to provide further information and assist with your registration. Please call us on +41 61 225 51 51, Monday-Friday from 08:00-17:00 CET, or email: diaeurope@diaeurope.org
Advertising Opportunities
Would you like to see your Company Ad and Logo in Data Connections or Data Basics? Schedule your ad before the end of this year to guarantee 2008 pricing! Contact Sue Abrahms at (414) 226-0362 - sabrahms@scdm.org for more information!
IN OTHER NEWS
SCDM October Board of Trustees Update
by: Derek Perrin
The fall colors are in full splendor here in the Northeast, and the witches and goblins will soon grace my front porch in anticipation of Halloween. What a terrific time of year!
I am all but speechless when I reflect on the past month, however if I had to use only one word it would be …"WOW!" After almost a year of dedicated planning, the 2008 Annual Conference is now behind us. And what a conference it was! The pre-conference tutorials had a record numbers of attendees, and I am very pleased to report that we exceeded all of our expectations in terms of attendance, exhibitors and sponsors. With over 600 attendees, 78 exhibitors and over $120,000 in sponsor contributions the 2008 Annual Conference was a tremendous success. Thank you to all.
For those who did not attend this year's conference, you missed out. I don't think I'll ever forget the fun we all had at the Texas Stadium! I saw several of you making your best attempts at kicking field goals, and going deep for a pass. Whoever said stadium food is bad was so wrong…the Texas barbeque was amazing, but what followed was truly the highlight of the evening.
The event at Texas Stadium event was arranged to honor the 2008 Data Driven Award recipient and this year's event was truly a show stopper. After the impromptu ceremonial signing of "National Anthem" to start off this event (thanks Kevin!); I had the privilege of announcing Arrowhead Electronic Healthcare, LLC as the 2008 First Place winner of the Data Driven Innovation Award. Further explanation of the three solutions can be found in this issue of Data Connections. Please share your congratulations with them for their receipt of this award!
In addition to fun and celebration this year's conference provided an excellent opportunity for learning more about our industry. From our opening keynote presenter David Cottrell to our closing FDA panelists, comments from the audience were extremely positive. I actually attended many sessions during the conference, and enjoyed chatting with many of our sponsors and exhibitors. As one of the co-chairs for this year's conference, I would like to extend a sincere thank you to our conference committee, our session chairs, all of our speakers, our outstanding sponsors and exhibitors, and finally to our dedicated SCDM staff who worked around the clock to make this year's conference a success. The role of conference co-chair has truly been my pleasure!
Additionally the Annual conference included several important announcements. First, I am very pleased to inform you that Susan Howard of GlaxoSmithKline, Nimita Limaye of SIRO Clinpharm Pvt. Ltd and Steven Powell of PRA, International, have been elected to the SCDM Board of Trustees. Their three-year term will begin January 1, 2009 and run through December 31, 2011. I know all of them well, through my association with SCDM, and I am confident that they will make terrific contributions to the BoT. Please join me in congratulating them.
Next the Business Meeting included several bits of information. Jonathon Andrus introduced our 2009 Officers who include:
- Linda Talley---Chair
- Ralph Russo---Vice-Chair
- Karen Hicks---Secretary
- Pam Norton---Treasurer
- Jonathon Andrus---Past Chair
He also provided recognition to those of us who will be stepping down, as our three-year term is up. Colleen Cox, Mary Foy and I officially complete our Board term in December. I would like to say thank you to Mary and Colleen for your contributions and hard work and say that I have had a great time serving with you!
Finally, Jonathan announced that Kim Breitbach, our current SCDM Executive Director, will be moving on to a new opportunity. Eloiza Altoro-Acevedo will be joining SCDM as the new Executive Director. Welcome Eloiza!
I want to wish Kim the very best in her new endeavor and thank her so very much for her dedication and support for SCDM…Kim, you've truly been the best and I will miss working with you!
Derek Perrin, CCDM
Getting to Know the CCDM
SCDM is proud to introduce Tania G. Sholar as a recent recipient of the Certified Clinical Data Manager (CCDM) designation. Cynthia is a Clinical Data Manager with Kendle International Inc.
1. Why did you become certified?
I felt that becoming certified shows my commitment to the field to current and future clients.
2. What challenges did you have taking and studying for the exam?
Just making the time to do so.
3. How has being certified benefited you?
Not sure yet. I hope that Kendle will recognize me and all future CCDMs publicly and monetarily. That would encourage others.
4. What materials did you use to study for the exam?
5. Can you provide helpful hints for those interested in taking the certification exam?
Form study groups and make it fun. We split out the topics and took turns discussing once a week over our lunch hour.
6. Any additional comments you would like to provide?
I am glad that I chose to do this. I am working toward incorporating more SCDM material within our department training.
SCDM Welcomed these NEW Members in September 2008!
|
Namit Agrawal Nathalie Allan Lynda M. Behymer Aaron Berlin Rosetta S. Bolden Tim Bower Nelson DeLeon Rebbeca Drake Kathryn Engstrom Kamaldeep Grover Qiliu Guo Kelly Hross Ram Kamath Rukmini Kethireddypally Anke Kruehs |
Jaya Kumar Ling Li Fenghua Liu Kim J. Longo Debra Marti Renee Mastalerz Jean L. Paulhus Brad Phelps Preetha Sharma Jaedra Stahan William Van Newkirk Nathan Von Garin Valerie K. Wilkins Stefan Zadrazil Neal Zundell |
SCDM congratulates the following members for entering
their 10th year of membership in September 2008!
Thi T. Nguyen