EDM and ERS/eCTD Tutorial 1: eCSRsDay & Time:
October 15, 8:00AM - 11:30AMInstructor(s):
Carolyn Callahan, MD
Administrative Assistant, DIA North America
DIA, United States
Nancy P. Smerkanich, MSc
Educational Liaison/Regulatory Science Doctoral Candidate
University of Southern California, United StatesDescription:
This tutorial will examine the myriad of issues around the authoring and publishing of clinical study reports and their related components for electronic submissions. This includes but is not limited to document granularity, hyperlinking and bookmarking, best practices for US and EU, as well as the relationship between tables, figures and listings and the data that is submitted to the FDA. A member of the eDATA team from the Center for Drug Evaluation and Research FDA will provide insight into how the data from study reports are utilized by the agency during the course of application assessments.
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At the conclusion of this tutorial, participants should be able to:
- Recognize and utilize granular CSRs for submissions
- Determine best practices for publishing standards for clinical reports
- Incorporate the agency and reviewer’s needs into standards and processes for clinical submissions
Regulatory Affairs/Operations, Medical Writers and Data/Project Managers who wish to gain a better understanding of the challenges of authoring and compiling clinical study reports and the supportive documentation and data that are used to evaluate them.