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SEND Implementation

 

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:

  • Introduction to CDISC
  • The Regulatory Climate
  • SDTM and SEND Overview and Background
  • The SEND Implementation Guide
  • SEND Metadata
  • Future Releases
Current Course Material Used: 
SENDIG v3, SDTM v1.2
Prerequisites: 

Knowledge of nonclinical study data is an advantage, but no specific pre-requisites are required to benefit from the course.

Course Length: 
2 Days
Course Type: 
Public, Private
Audience: 
Data Manager
Nonclinical Study Personnel
Programmer
Biostatistician