SCDM will be hosting its next series of educational webinars starting in November. The topic for our next series is Coding. This year's Fall Conference included an in-depth Introduction to Coding tutorial, and this series will cover specific areas of coding. The first webinar will cover coding at a broad level, independent of dictionaries, whereas the second webinar will be focused on areas of high interest specific to the two most widely used dictionaries.

Coding I - November 8, 2007 - Coding Conventions and Best Practices
This webinar is especially designed for Coders, Data Managers, Study Coordinators, Monitors, Biostatisticians and anyone else involved in the collection and cleanup of reported terms, Managers responsible for creating and/or implementing coding and review strategies and processes, Data Entry personnel as well as CRF Designers.

Coding II - December 6, 2007 - Coding Dictionaries: A Look at MedDRA and WHO Drug
This webinar is especially designed for Coders, Data Managers, Study Coordinators, Monitors, and anyone else involved in the collection and cleanup of reported terms, Managers responsible for creating and/or implementing MedDRA upversioning strategies and processes, Managers responsible for implementing WHO Drug, Medical Reviewers, Biostatisticians, and anyone else involved in the review and analysis of coded data.

All webinars will be 90 minutes in length and begin at 11:00 a.m. CST.

Learning Objectives for Coding I:

Upon completion of this webinar, the participant will be able to:

• Describe coding process and how the coder can improve the quality of data
• Recognize possible styles of coding conventions and the need for consistency in coding
• Apply GCDMP best practices for coding
• Relate the need for partner/team collaboration to improve the quality of data

Learning Objectives for Coding II:

Upon completion of this webinar, the participant will be able to:

• Describe and understand methods for versioning
• Apply best practices to successfully version MedDRA coded data
• Provide recommendations for how to create an effective MedDRA versioning strategy
• Describe dictionary management system requirements to successfully upversion data in MedDRA


• Describe the differences between WHO Drug dictionary Formats B1, B2, and C
• Explain the structure and content of the WHO Drug C Format dictionary
• Cite of the considerations and challenges of coding medications to Format C
• Discuss dictionary management system requirements for implementing the WHO Drug C Format dictionary.

Presenters for Coding I

Lisa Nastari
Lisa Nastari BSN, RN joined Clinical Coding & Dictionary Management at Genentech in 1999. Prior to this, she worked in Pediatric Critical Care, Maternal-Child Health and Pediatric Bone Marrow Transplantation at UCSF and Lucile Packard Children's Hospital at Stanford. She holds a BS in Nursing from the University of San Francisco and a BA in Biology from the University of California, Santa Barbara. She holds active certifications in Pediatric Advanced Life support and Oncology Nursing Society Cancer Chemotherapy, where she is also an active member.

Eileen Monge
Eileen Monge BSN, RN joined Clinical Coding & Dictionary Management at Genentech in 2001. Prior to this, she worked in Pediatric Critical Care, at UCSF and Pediatric Liver & Kidney transplant at California Pacific Medical Center. Other roles include Manager of Blood collections for American Red Cross. She holds a BS in Nursing from the Mount St. Mary's College. Active member of the Oncology Nursing Society and holds a certification in Oncology Nursing Society Cancer Chemotherapy.

Connie Krause
M. Connie Krause BSN, RN joined Clinical Coding & Dictionary Management at Genentech in 2005. Prior to this, she worked at Genentech in Drug Safety and the SPOC Program as a Reimbursement Specialist. Her clinical experience includes legal nurse consulting, Unit Manager for NY Blood Services, and Oncology Nursing at MD Anderson and Mt. Sinai in NYC. She holds a BS in Nursing from St. Luke's College in the Philippines. Active member of the Oncology Nursing Society and holds a certification in Cancer Chemotherapy.

Presenters for Coding II

Henry Chen
Henry Chen has more than 15 years experience in the biopharmaceutical industry, including his current position as a Principal of ThesIS (Thesaurus Information and Strategies, Inc.), a company specializing exclusively in the coding and versioning of data for clinical trials and drug safety. He has spent the last 12 years working with medical dictionaries such as MedDRA, WHO Drug, COSTART, and ICD-9. Henry is one of the earliest users of MedDRA, with involvement starting from the MedDRA 1.0 Alpha version in 1995. He has pioneered sophisticated techniques and systems for the coding and versioning of terms for both MedDRA and WHO Drug.

Debra Barnes
Debra Barnes has more than 20 years experience in the biopharmaceutical industry, including her current position as a Principal of ThesIS (Thesaurus Information and Strategies, Inc.). Debra manages all of ThesIS's coding operations and is responsible for ensuring the overall accuracy and consistency of data coded and versioned by ThesIS. Prior to ThesIS, Debra was the Director of Clinical Data and Systems Management for Roche Global Development in Palo Alto, California. She was also the Global Head of Thesaurus Administration for Roche, responsible for the formation of Roche's worldwide coding group.

Leslie Tozzini, R.N.
Leslie Tozzini is a California Board Certified Registered Nurse with more than 19 years of experience in the biopharmaceutical industry, including more than 15 years as an expert coder. As one of the lead coders at ThesIS (Thesaurus Information and Strategies, Inc.), Leslie has coded extensively to standard dictionaries such as MedDRA, WHO Drug and COSTART, as well as to various proprietary dictionaries. Prior to ThesIS, she coded extensively as a Safety Data Associate for Roche Global Development, for Genentech, Inc., and for Syntex Research. Leslie provided primary nursing care in a hospital setting for seven years before joining the biopharmaceutical industry.

Brian McCourt
Brian McCourt, CCDM is an active leader in clinical data management and significant contributor to various professional society, academic and standards development initiatives in the clinical research industry.

Mr. McCourt is Associate Director of Clinical Research Informatics at the Duke Clinical Research Institute, providing leadership to informatics projects and the clinical data systems supporting research and integrated patient care activities. He currently co-chairs the HL7 Cardiology Special Interest Group and HL7 Clinical Interoperability Council and is member of the NIH Roadmap Interoperability Working Group. Mr. McCourt received the Certification in Clinical Data Management when the designation was initially created by the Society for Clinical Data Management and is a key contributor to the SCDM's Clinical Data Management Training Program. His specific interests are related to integration of data for clinical research projects with complex operational requirements, such as core labs, electronic health records and enterprise business systems.

Mr. McCourt received his bachelor's degree from Saint Anselm College in Manchester, New Hampshire and worked at Massachusetts General Hospital in Boston Massachusetts before relocating to North Carolina to join the Duke Clinical Research Institute.

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