Learn about ambiguities in the SEND standard that need to be resolved for FDA Submission and Review Purposes

To request a copy of the webinar presentation, please contact: get_started@pointcross.com

Abstract

The FDA is already using NIMS (Nonclinical Information Management System) to receive and review submissions in standardized formats that must conform to the CDISC SEND standard and the FDA’s Nonclinical Validator Specifications. The Nonclinical Validator Specifications reflect the FDA’s implementation of the SEND standard driven by their review needs.

In this webinar we discussed ambiguities in the SEND standard that need to be resolved during your implementation to ensure that your submitted data is fit for review. This webinar covered the following topics:

  • Data Fitness Checks to meet analysis needs of reviewers
  • Ambiguities in the SEND model that could lead to different implementations of the standard
  • Approaches to achieving consistency across your submitted datasets

Panelists

  • Gitte Frausing, SEND Work stream Leader and Principal Consultant at Data Standards Decisions Aps
  • Kristi Johnson, Team Lead for our FDA Data Standardization Program
  • Shree Nath, VP PointCross Life Sciences and Program Manager for NIMS at the FDA

To request a copy of the webinar presentation, please contact: get_started@pointcross.com