SCDM 2010 Annual Conference

2010 Annual Conference: Early Registration Ends July 30!

Join the Society for Clinical Data Management in Minneapolis, MN, this October for the 2010 SCDM Annual Conference. This year's program features session topics suited to meet all areas of expertise within the clinical data management industry.

Check out the preliminary program for complete session information.

Register Now!

New for 2010:

• Debate Session: The Future of CDM at Sponsor Organizations: Hear from industry experts on the changing roles of clinical data management.
• Device Sequence: Unique challenges in medical device trials. Featuring a roundtable discussion with the U.S. Food and Drug Administration's Center for Device and Radiological Health.
• Leadership Sequence: An advanced track catering to the needs of senior level management in CDM.

Other highlights:

• Third Annual FDA/SCDM Forum: An update and question-and-answer session with regulatory authorities.
• Data Driven Innovation Award Reception: Highlighting new advancements in clinical data management technology, reception and presentation offered to all attendees and exhibiting companies. Learn more about the award.
• Exhibit Hall: Network and learn about new products and services from more than 60 CDM industry companies. Become an exhibitor.

 Reminder: Board of Trustees Nominations/Application Due July 19

Your vision and leadership are needed to guide the future of SCDM and the clinical data management industry. Complete an application or nominate a colleague by July 19.

All SCDM members are eligible to apply for the board. New trustees will be elected by the membership in August, with results announced at the SCDM Annual Conference in October.

Eligibility and Process
All SCDM members are eligible to serve on the Board of Trustees. Members may nominate themselves or other SCDM members as candidates. Please carefully review the Board of Trustees Fact Sheet and the SCDM strategic plan prior to submitting your nominations.

All nominees will be required to complete an application. Applications will be reviewed and approved by the Nominating Committee prior to announcement of the final slate of candidates Monday, August 2.

Virtual voting will open Monday, August 2, and close Friday, August 20, via the Members Only section of the SCDM website. Election results will be announced at the 2010 Annual Conference, October 17-20.

All Board members are required to attend four face-to-face meetings per year. Board members are expected to cover their costs for transportation and lodging for these meetings. Additionally, board members are invited to attend a Board orientation and the Board meeting held at the 2010 Annual Conference on Saturday, October 16.

 SCDM Invites Your Webinar Proposals

We want to hear from you!

Are you an acknowledged expert in your field?
Do you have a clear and dynamic speaking voice?
Are you able to cover the topic with examples and enthusiasm for the subject?
Is there a Data Management topic you are interested in learning about?

Webinars provide brief, focused learning to a live global audience. Each webinar is 90-minute and consists of a 60-minute presentation followed by 30-minutes of questions and answers.

Submit your proposals today!

 Outsourcing Strategy and Methodology: Making it a "Win-Win"

July 15 & July 22
11 a.m. CDT
60-minute presentation followed by 30-minute Q&A

Presenters:
Dr. Nimita Limaye, CCDM, is currently working as the vice president and global head (strategic data services & medical writing) at SIRO Clinpharm Pvt. Ltd., a leading Indian CRO, with a global presence across multiple geographies. She leads up all strategic engagements for clinical data management, biostatistics and programming and medical writing, and plays a key role in driving strategy, winning and establishing key engagements, ensuring sustainability and profitability, and driving operational excellence. She also serves as the vice chair of SCDM.

Ralph Russo, CCDM, is director of clinical data management and standards at Merck Research Laboratories. In this role, he has responsibility for EDC builds and external data management across all phases and therapy areas. Ralph has more than 23 years of experience in the pharmaceutical industry.

Part 1 - Step I: Outsourcing

• Outsourcing Strategy - why outsource and to whom
• VIPCO/FIPCO
• Choosing a Business Model
• Short-listing Vendor RFIs and Proposals

Part 2 - Step II: Sustaining the Relationship

• Implementation Models (FTE or FSP)
• Governance Models
• Oversight Structure
• Communication Processes and IEPs
• Managing Expectations
• When It Doesn't Work
• Risk Management

 SCDM is Soliciting Articles on Data Quality

The Society for Clinical Data Management is soliciting articles for the Fall issue of Data Basics, its quarterly publication. The theme for this issue is Clinical Data Quality. Please consider submitting an article for publication. You do not have to be a data manager to submit, nor do you have to be a member of SCDM. We are also very interested in the views of non-data managers on your quality perceptions and requirements, and your views on how the data quality process is currently handled.

Share your knowledge with others involved in data quality and enhance your professional reputation! For those who are certified CDMs, publishing also counts for CEUs towards CCDM® recertification.

Here are some suggestions to get you thinking, but feel free to take a different angle on one of these, combine them, or choose another data quality topic altogether. Further information is included below the list.

1. Data quality - you know what it means to you, but do you know what it means to your study team? Who should be involved in data quality? Interview your team: go beneath the "it means clean data" answers to discover what their expectations and assumptions are.
2. Data quality - who (or what) drives the definition in your organization, and why? Are you exploring different definitions that perhaps don't match the traditional approaches?
3. Are all your data equally important? If not, what determines which data is important to you? Do you treat them differently from "non-important" data? In what way(s), and why? Do you apply any kind of risk assessment/management to deciding this, and if so, what and how?
4. Got problems (with your data quality)? Get in touch with the personal side of data quality - what are your pain points? True stories of data quality problems (and how they were overcome)...share yours!
5. What are the challenges in data quality when conducting trials internationally? When sponsors and sites are from different countries, how do different opinions about data quality collide? How have you tackled these issues?
6. When regulatory requirements differ between countries in an international trials (e.g., different requirements for date of birth data), how is this handled so that the data are comparable for analysis (a fundamental requirement for data quality)? Are there different approaches for different situations or countries?
7. What kind of data quality checking do you do at each step of the study process? How do you check the quality of your CRFs? What do you check in the EDC application? What kinds of checks do you run off-line, and why then instead of at another point in the process?
8. Error free database? Is this possible? Realistic? Desirable? How to communicate the reality of data quality to your study team.
9. Data quality - developing the plan for data cleaning with the end in mind
10. The language of data quality - do the words get in the way? (i.e. clean, error-free, validation, verification, quality, good enough, code, panel, status, et al). What words do we have in clinical research that are used different ways by different groups? Without a common vocabulary, we cannot hope to ensure quality!
11. Quality in outsourcing partnerships - working with a CRO - how do you, as the sponsor, ensure the quality of the data without redoing the work yourself? How to you, as the CRO, ensure that the sponsor has actually reviewed the specs you sent them?
12. Celebrating what's right - what data quality processes do you have in place that work?
13. What does your Data Management Plan contain? Write a primer on the contents of a good DMP, why each section is included, and what role it plays in ensuring data quality.
14. Do the CDMs and CRAs in your organization collaborate? How? Why is this a good idea? What barriers exist to this collaboration and how can you overcome them?
15. What is the relationship between standards and quality? If you have standards, do you automatically have quality? If not, how can you translate from one to the other?
16. Data quality issues in the interface between clinical research and EHR systems - what are the challenges, why do they exist, how can they be overcome?
17. Metrics and data quality - how do you measure data quality? Using what metrics? What do they tell you? What do they not tell you? Why did you choose these? How are they defined and calculated? What are acceptable levels? Why?

Article Submission Requirements:

General

• Length: 1 to 3 pages, 500 - 1500 words, excluding references and cover page
• Audience: primarily clinical data managers
• Tone: relatively informal
• Deadline: August 1, 2010
• Co-editors: Janet Welsh, Boehringer-Ingelheim, janet.welsh@boehringer-ingelheim.com, and Kit Howard, Kestrel Consultants, kit@kestrelconsultants.com
• Send articles and accompanying materials to info@scdm.org, with the subject line clearly indicating a publication submission; hard copy (optional) may be sent to SCDM, 555 East Wells Street, 11th Floor, Milwaukee, WI 53202-3823
• Further information: info@scdm.org

Additional submission details
http://www.scdm.org/publications/article_submission_guidelines.pdf

 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 creation or revision.

SCDM is looking for three to five Subject Matter Experts (SME's) to work on the following chapters: Data Storage, Detecting Fraud, Risk Management and Training.

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.

 Call for Online Course Content Developers

Do you love to teach? Have you been told you're a natural born educator? Is training part of your job? Do you have areas of CDM expertise? Would you like to give back to the CDM profession?

If you answered "yes" to any of these questions, we invite you to join the following Content Development Teams for new SCDM online courses. Active development time when most meetings will occur is included beside each course.

Work includes drafting a course outline, identifying content resources, creating slide decks, drafting discussion questions and creating assessment items. You'll be guided by an experienced instructional designer. As an added benefit, you'll learn about the process of creating online courses and be rewarded with participation credits that count toward renewal of your CCDM.

To apply, please send the following to schaplock@scdm.org:

• Short paragraph outlining why you want to join the team
• Why you are qualified
• The course you'd like to work on
• Along a copy of your resume or CV.

 SCDM Welcomed These NEW Members in May 2010!

 SCDM Congratulates the Following Member for Entering Her 10th Year of Membership in May 2010!

Paula Strasberg, PhD