Important Announcements

Professional Development Opportunities

2009 Webinar Schedule
Trends in CDM	January 29 & February 5
Data Management & Oncology Trials	February 25 & March 4
Data Manager to Data Leader	March 26
Data Query Processing & Tracking	April 23 & 30
Electronic Data Capture	June 4, 11 & 18
Emerging and Established Standards	July 9 & 16
Patient Reported Outcomes	August 13 & 20
Data Base Validation and Surviving an Audit	September 10 & 17
Project Management	November 5, 12 & 19

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2009 Leadership Forum

There are a LIMITED number of seats for the Leadership Forum
and they are filling up quickly!
SCDM wishes to invite you to participate in the 2009 Leadership Forum, March 15-17, 2009 at the Nashville Marriott on the Vanderbilt University campus. It is becoming the principal forum for strategic discussions of interest for CDM professionals. 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. Registration is limited to upper level CDM professionals.

Interested in Sponsoring the Leadership Forum?
Your company would have exposure to leaders and decision makers within the CDM industry. There are LIMITED sponsorship opportunities for the Leadership Forum. Please visit the SCDM Leadership Forum Sponsorship page for the opportunities that are still available.

If you have any questions about the 2009 Leadership Forum, please call (414) 226-0362 or email info@scdm.org.

SCDM would like to thank the following sponsors:


Monday Luncheon

Monday Reception

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Have you formed a Study Group to Prepare for the CCDM® Exam?

Share your knowledge of best practices.

Let us know your group is meeting.

SCDM is looking for CDMs who have formed or participated in a study group that helped them prepare to sit for the Certified Clinical Data Manager exam. The Society is assembling a group of volunteers to contribute to a best practices page of the Education Portal (http://portal.scdm.org) that will serve as a guide for forming effective study groups. This is a short term project that will contribute to the content of the web page on what works in terms of structure, content, frequency and support materials. Your experience is vital to the successful launch of this resource.

As part of this initiative, SCDM will be posting locations that are hosting study groups. If you have a study group planned or that is meeting now and would welcome people to join, please let us know so that we can post it on the website.

Please email Sharon Kayne Chaplock at schaplock@scdm.org to respond. The group will meet via teleconference beginning late January.

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SCDM RELEASES DATA MANAGEMENT PLAN CHAPTER FOR THE GCDMP

The Society for Clinical Data Management released the newest addition to its Good Clinical Data Management Practices (GCDMP) document with the publication of the Data Management Plan chapter in December. Charlene Dark, co-chair of the GCDMP Committee, commented that "In our continued commitment to advancing the profession of clinical data management, SCDM's GCDMP committee is very excited about the publication of the Data Management Plan chapter. This chapter is the first set of documented best practices in developing a data management plan. We believe that we have compiled a sound guidance for data managers, and we have made great strides in the direction of more standardized practices when developing and maintaining a data management plan. We are very proud of this accomplishment."

The Data Management Plan chapter is available to members through the Society's website. Non-members are able to access the entire updated document for a fee. A podcast version of this newest chapter is in production and scheduled for release in the first quarter of 2009.

SCDM would like to recognize and thank all subject matter experts who contributed to the development of the Data Management Plan chapter, including: Michele Goldstein (University of Rochester), Laura Fazio (DePuy Orthopaedics, Inc.), Reza Rostami (DCRI), Denise Redkar-Brown (Cetero), Joseph Pascua (Genentech, Inc.), Pam Harvey (American College of Radiology) and Mary Baldovsky (PharmaNet). Further, the chapter benefited from extensive peer review by the entire GCDMP committee, SCDM's Board of Trustees and an international review from selected members of INCDMA. To learn more and to access the chapter, go to www.scdm.org.

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SCDM Launches NEW Education Portal

SCDM has introduced the Education Portal to its website to assist clinical data managers prepare to sit for the Certified Clinical Data Manager (CCDM®) exam. The Education Portal will also support Clinical Data Manager's ongoing professional development needs. SCDM has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

The site includes:

1. A self-assessment tool to help identify areas of strength and weakness by competencies assessed in the CCDM® exam;
2. A list of exam competencies along with information about exam logistics, a certification guide and an application;
3. A section on coaching offering tips for forming study groups and a link to Data Matters, SCDM's Listserv;
4. Study reference materials which are identified and linked to the SCDM Media Store powered by Amazon.com. The store offers an easy way to order relevant books and other materials online; and
5. Educational opportunities and resources including registration information about upcoming webinars and workshops, and archived versions of past offerings.

The site can be accessed from SCDM's homepage at www.scdm.org or directly by entering http://portal.scdm.org.

With the new web 2.0 technology stack used for this portal, content updates and new tools such as forums, online classes and collaboration tools such as blogs and wiki's will help SCDM bring a highly interactive format to members. With these exciting possibilities, we will need your help in the form of feedback to help us meet and exceed your needs and expectations as far as content and tools. Feel free to let us know how this offering can be improved by emailing info@scdm.org.

A second version is already underway and will be enhanced with the addition of a practice exam and SCDM University, a repository of online courses that will address topics related to Study Startup, Study Conduct and Study Closeout.

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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

Click Here To Join For 2009

Educational Opportunities

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 three offerings. For a more detailed description, go to the SCDM website at http://www.scdm.org/events/webinars/archive/

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 Acquisitions - Introduction to Data Collection
and Data Management Practices in Cancer Research (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.

Clinical Trials Abroad: Asia -
Webinar #1: Blended resourcing models for global organizations
Webinar #2: East Meets West: - Working effectively with colleagues in different countries and time zones
The recent announcement that the FDA plans to open permanent offices in China demonstrates the growing importance of global drug and medical device development in Asian countries. This webinar will address the critical factors in successfully creating and maintaining a global organization. Examples will illustrate blended resourcing models that result from R&D expansion, company expansion, and outsourcing models and relationships. Presenters will address project startup, data flow and data quality, as well as how to communicate effectively with colleagues in different countries. Rewards, risks and the impact on the future of CDM is included.

To access any of the series listed here, go to
http://www.scdm.org/events/webinars/archive/

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"DataMatters" Listserv - 136 Members Strong!

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!

http://www.scdm.org/datamatters

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Enjoy reading Data Basics? Now is your chance to contribute to the next issue!

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

GCDMP SME's Wanted: DATA STORAGE Chapter

Opportunity for Short Term Project GCDMP Volunteers:
SCDM is looking for 5-8 Subject Matter Experts (SME's) to work on the Data Storage chapter. 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 guidances.
• Must have the available time needed to serve in the capacity of SME, estimated to be approximately 30-40 hours over the course of the assignment.

Work will begin in mid-January and continue until the chapter is complete - for approximately 2-3 months.

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 Sharon Kayne Chaplock via e-mail schaplock@scdm.org

In Other News

SCDM December Board of Trustees Update

Happy New Year!

This is my last edition of the SCDM Board of Trustees Update, as I am now officially retired from the Board of Trustees. Starting next month, my esteemed colleague, Paul Clarkson, CCDM, will be taking over the reigns as author of the Board of Trustees Update. Thanks Paul!

The SCDM Board of Trustees will be meeting in Phoenix on January 19 – 20 to discuss our goals for the Society for 2009 and beyond. Paul will provide updates on the outcome of that meeting next month…stay tuned!

Have you had a chance to check out the SCDM Education Portal? If not, be sure to do so soon! There is some great material in here with access to things such as a self-assessment exam, certification prep materials, links to both upcoming and archived Webinars and so much more. Check it out at: http://portal.scdm.org/

Finally, the SCMD Leadership Forum will be taking place March 15 – 17th in Nashville, TN. Our Leadership Forum committee has developed an exciting agenda for this year’s meeting, which will allow senior leaders in DM the opportunity to interact with peers from across the industry. If you have not already done so, please consider registering for this year’s Forum. For more information, please check out the following link: http://www.scdm.org/events/leadership2009/

All my best for a successful and prosperous 2009!!!

Derek

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Getting to Know the CCDM®

SCDM is proud to introduce Linda Massey as a recent recipient of the Certified Clinical Data Manager (CCDM®) designation. Linda is a Senior Data Manager with the New England Research Institutes in Watertown, MA.

1. Why did you become certified?
My company expressed an interest in having DMs certified under this program. When I looked into it, I decided it would be an enhancement to my knowledge and benefit my overall career.

2. What challenges did you have taking and studying for the exam?
The biggest challenge was figuring out what to use as study materials and what to focus on reviewing.

3. How has being certified benefited you?
So far the greatest benefit has been from having to increase my knowledge to prepare for the test, which makes me feel better equipped for my job. Having to recertify every 3 yrs will push me to stay on the top of new developments and educational opportunities so I can continue to advance my skills.

4. What materials did you use to study for the exam?
GCDMP, ICH, various articles recommended on the SCDM website

5. Can you provide helpful hints for those interested in taking the certification exam?
The exam covers a broad range of topics/areas. To avoid feeling overwhelmed in studying, concentrate on reviewing those competencies you are least familiar with. If you do not use MeDRA - become familiar with it. Learn the lingo used in the GCDMP. Your experience vocabulary may be somewhat different than terms used in the test. Don't rush through the test. There is ample time available to complete it.

6. Any additional comments you would like to provide?
This is definitely something I encourage other CDMs to do.

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SCDM Welcomed these NEW Members in November 2008!

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SCDM congratulates the following members for entering their 5th year of membership in November 2008!

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SCDM congratulates the following members for entering their 10th year of membership in November 2008!

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CDM Standard Needs Your Comments!

Work has been started on a defined list of tasks performed in the collection and management of clinical research data. The work originated out of a project employing a formal usability framework to compare two systems used for management of clinical research data (Nahm, Zhang 2008). Aside from the usability work, having such a list will improve the indexing of data management literature making it easier for all of us to search and retrieve information, and that it will help standardize the words that we use to describe our work. As such, SCDM assisted by enabling focus groups that were held at the September 2008 SCDM Annual conference to review and inform this list. Additional comments from the membership are sought ! Comments obtained through this process will be compiled, and an updated document will be disseminated and provided to the Medical Subject Heading (MeSH) Terminology.

How to Comment
Comments will be accepted for one month after Data Connections publication. The following questions may help your review:

1. Are there tasks missing from your section? If so, what are they?
2. Are there definitions of terms in your section that you are uncomfortable with? What changes or other sources for definitions would you suggest?
3. Are there synonyms for any of the terms in your section that you are aware of?
4. Is the hierarchy correct? If not, what would you change?
5. What objects (i.e. things needed to perform the task, e.g. a protocol is needed to design a CRF) are required for each task in your section?

Please comment by emailing meredith.nahm@duke.edu. Complete sentences are not needed, just bullets will be fine.

What is a Work Domain Ontology?
An approach, called a work domain ontology is increasingly being used in informatics to specify the work (activities, objects and roles) that software systems need to support. In knowledge representation and applied philosophy, an ontology can be thought of as an explication of a system of categories of existing entities.¹ A work domain ontology describes the basic structure (goals, objects, constraints, operations, and inherent complexity) of the work that the system together with its human users will perform. Work domain ontologies are purposively explicit, abstract, and implementation-independent description of that work.² As such, they describe a body of work, and are useful in requirements specification for technology design, as well as an essential step in usability evaluation.^3,4,5,6 Work domain ontologies can also serve as a framework for research and indexing of research for information retrieval.

Importantly, the Clinical Research Data Management work domain ontology presented here is intended to cover the tasks performed by data managers. The objects used to perform those tasks, such as a case report form, are not explicitly shown here, although the intent is to add them based on the focus groups and on information obtained from this round of comments. Additionally, detail about different methods that may be used, e.g. interactive double data entry as opposed to use of third person compare has been moved to the definitions. As such, the current version does not distinguish between EDC or paper methods, i.e. it cares only that data were entered, not whether a web-based system was used. Also of importance, the work domain ontology aims to capture the tasks, and does not portray the iterative nature of our work. Readers may notice that some tasks included in the ontology, although critical to the management of data, are not performed by most Data Managers, e.g., medical record abstraction, data entry, clinical measurements, source document verification. These tasks are included because they impact the data and because the Data Manager, in managing the data needs knowledge about the methods employed, and may have input into those methods.

Prior Work
Limited work has been done to formally and systematically describe the activities and objects used in managing clinical research data. In 1999, the Society for Clinical Data Management published a task list for the profession.⁷ This list consisted of sixty-seven tasks grouped into nine categories. The 1999 task list was used as one input to the current ontology, although it contained no definitions. Later, in 2004, SCDM released their National Certified Clinical Data Manager (CCDM) certification exam and associated core competencies.⁸ The current core competency set for the exam consists of 112 tasks grouped into twenty six categories, core competencies.⁸ Both of these SCDM consensus task lists are based on common job responsibilities and necessary skills for the profession. As such, the lists include job tasks that are not direct operations on data, i.e. a superset of our research interests. In addition, the membership of SCDM has historically comprised individuals from industry rather than from government funded research or academic institutions, thus, the lists may not cover some components of clinical research done in these arenas.

A different approach to identification of clinical research related tasks was taken by Deitzer, et al, who abstracted tasks from twenty cancer clinical trial protocols, systematically generating a list of 102 activities in the conduct of clinical trials.⁹ This list is significantly broader than operations performed on clinical trial data.⁹ In addition to the extant task lists, the Data Management Association (DAMA), the Clinical Data Interchange Standards Consortium (CDISC) and SCDM maintain glossaries, however, the majority of terms are nouns, rather than activities. Likewise, while the BRIDG information model covers regulated clinical research, objects are covered, but tasks are not. The Ontologies of clinical research and clinical investigation are similar in that respect. A classification of tasks or activities and associated authoritative definitions does not yet exist for operations undertaken in the collection, processing, and management or research data.^10,11,12

The work domain ontology presented here was developed based on the author's domain expertise, an extensive literature review, and mapping to the SCDM certification exam core competencies.

Focus Groups at the Annual Conference
Focus groups are unstructured interviews with small groups of people who interact with each other and the group leader. They have the advantage of making use of group dynamics to stimulate discussion, gain insights and generate ideas in order to pursue a topic in greater depth.¹³ Three focus groups were held at the 2008 SCDM Annual Conference to assess the draft ontology. There were from 3-6 people in each group. The ontology was split into sections of approximately fifteen tasks. Attendees reviewed their chosen section and then participated in discussion around the following questions:

1. Are there tasks missing from your section? If so, what are they?
2. Are there definitions of terms in your section that you are uncomfortable with? What changes or other sources for definitions would you suggest?
3. Are there synonyms for any of the terms in your section that you are aware of?
4. Is the hierarchy correct? If not, what would you change?
5. What objects are required for each task in your section?

The focus groups were reviewed and approved by the IRB at the author's institution.

Future Work
The work domain ontology will be updated based on comments from Data Basics readers. Afterwards, the ontology will be updated and published in it's initial version. Terms from the work domain ontology and their definitions will be shared with existing glossaries and, importantly, with the Medical Subject Headings (MeSH) terminology used to index MedLine. Additionally, the work domain ontology will remain available as a context for research in the field.

Click to view Clinical Research Data Management Work Domain Ontology: Definitions