This webcast is part of the Global Strategies for Clinical Research Information 2006 series sponsored by CDISC and AMIA.
Learning Objectives
- Understand the purpose of a domain analysis model
- Gain an understanding of the history, progress and current status of the BRIDG model
- Learn how the CDISC and HL7 standards are represented in the model
- Learn the benefit of the UML modeling from the perspective of trial design
Program content
The Biomedical Research Integrated Domain Group (BRIDG) model is a means of bridging various standards, different organizations and the domain of clinical research with that of healthcare. It is a domain analysis model of protocol-driven research. This webcast will provide an overview of the BRIDG, including purpose, history, status and future. It will also include a summary of the CDISC and HL7 standards that are now being represented in this model.
Who Should Attend?
Information Technology Specialists, UML Modelers, all those interested in harmonizing standards across the clinical research and healthcare industries.
About CDISC
CDISC is an open, multidisciplinary, non-profit organization committed to the development of worldwide standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The CDISC mission is to lead the development of global, vendor neutral, platform-independent standards to improve data quality and accelerate product development in the pharmaceutical industry.
About Doug Fridsman, Cara Willoughby, Diane Wold
Douglas Fridsma, Ph.D. is Assistant Professor of Medicine at the Center for Biomedical Informatics, with a joint appointment in the Intelligent Systems Program. He is currently the faculty lead in the caBIG project through the NCI to develop, implement, and evaluate standards-based, interoperable clinical trials applications for managing clinical trials. Dr. Fridsma’s research interests include the development of computational tools to study patient safety, clinical work processes, and collaboration between healthcare providers, with a specific interest in simulation, clinical trials, and oncology care.
Cara Willoughby has eight years of pharmaceutical industry experience in clinical trial regulatory information and communications. Through her technical understanding of protocols, ICH regulations, and business processes, she has been influencing data interchange standards development in the Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL7) since early 2003. She currently co-chairs the Protocol Representation (PR) Group, a volunteer organization of clinical trial protocol experts who are collaborating to develop standards for the interchange of protocol information among systems and stakeholders within the biopharmaceutical and healthcare industry. On behalf of the PR Group, she has been actively involved in the Biomedical Research Integrated Domain Group (BRIDG) project since August, 2004.
Cara is the lead technical consultant for regulatory Global Scientific Information and Communications at Eli Lilly and Company. She has held previous positions at Lilly as an Associate Scientific Communications Consultant, Team Leader, and Senior Medical Writer. In these roles, Cara has initiated and led several process improvement initiatives, significantly contributed to two major global marketing applications, and has been instrumental in setting the vision and defining requirements for electronic next-generation authoring tools. Prior to her career at Lilly, Cara earned a Bachelor of Arts Degree in Zoology and Psychology from Miami University of Ohio and a Master’s degree from Purdue University in Reproductive Physiology and Cryobiology.
Diane Wold received a Ph.D. in Statistics from the University of North Carolina at Chapel Hilll. She has worked at GlaxoSmithKline and predecessor companies for over 20 years, as a project statistician and as a manager of statisticians, data managers, CRF designers, and dictionary coders. Diane has been progressively more involved with data standards over most of her time at GSK, and for the last five years she has been a manager in clinical data standards. She has been a member of the CDISC SDS team for three and a half years, and has also been a member of the CDISC/HL7 Protocol Representation group and the BRIDG modeling group. She has led the Trial Design Model subteam, which developed the Trial Design Model section of the SDTM and is currently modeling the more detailed information in the protocol schedule of activities.
