SEND Implementation

2-day Course
Language: English

 

Background

The CDISC Standard for the Exchange of Nonclinical Data (SEND) Implementation Guide provides the structures and implementation rules for the submission of data from single- and repeat-dose toxicity studies and carcinogenicity studies. Its foundation is the CDISC Study Data Tabulation Model.

 

Target Audience

This course primarily designed for individuals in nonclinical research who will be involved in the implementation of the SEND standard. Included are people involved in data preparation or who will be interacting with partners creating SEND datasets. This course should also be useful to those involved in the review of SEND data by showing the data structures behind the views generated by viewing tools.

 

Course Style

Lecture with interactive discussion interspersed with hands-on exercises to reinforce SEND concepts.

 

Course Content

 

  • CDISC Overview
  • SDTM and SEND Overview and Background
  • The SENDIG
Pre-requisite: An understanding of data collected in toxicology studies as well as experience in conducting studies or managing study data.