October 9 @ 4:00 – 5:00 pm
Speaker: Anita Walden
Presented from Duke University
Broadcast Link: Seminar
This seminar will provide a general overview of many of the standards (internal and external) in development and used for clinical and observational research. Several of the various standards development organizations, initiatives, and institutions involved in standards creation will be highlighted. The intended goals, together with the opportunities and implementation challenges arising from the rapid increase in the interest of clinical research standards, will be reviewed. Finally, gaps in the standards and what the research community can do to enhance their progress will be discussed.
Anita Walden manages informatics projects and initiatives for the Duke Translational Medicine Institute. She has a background in Clinical Research Data Management in academic, pharmaceutical, and contract research organizations (CROs). In addition to consulting for other research organizations, she has managed national and international therapeutic data standards development projects funded by National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) since 2003. She is Co-Chair and Publishing Facilitator of the HL7 Clinical Interoperability Council Working Group and Trainer for the Society of Clinical Data Management (SCDM) University Training program.