Understanding Changing CDISC Guidelines for Data Acquisition & Submission
Phoenix, AZ, June 4, 2013 – What are CDISC Standards? Will CDISC Standards be required for FDA Submission? How does this affect the clinical research team? Shannon Labout will answer these questions and more in her presentation at the Society of Clinical Research Associates Valley of the Sun (SoCRA Phoenix) Chapter Meeting on Tuesday, June 4, 2013 in Phoenix, AZ.
Shannon Labout is a Certified Clinical Data Manager (CCDM) with 18+ years experience in healthcare technologies, project management and clinical research. She has managed clinical data management teams in both the U.S. and Europe, and has participated in CRF standardization, and contributed to data standards development, harmonization and implementation at multiple global pharmaceutical organizations and CROs for more than a decade. She has been an active member and team lead on the CDASH team since 2006 and on the SDS team since 2007. Shannon is the past Senior Director of Education at CDISC, and has been training on CDISC standards in North America, Europe and Asia since 2007.
The Society of Clinical Research Associates, Inc. is a non-profit, professional organization dedicated to the continuing education and development of clinical research professionals. The SoCRA Phoenix Chapter is a forum for anyone interested or working in clinical research. Visit www.socra.org for more details.