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Course Description

This course will provide attendees an understanding of how the CDISC SEND standard can be applied for general toxicology study data, and how SEND data tabulations should be considered in the nonclinical study conduct process.

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.

Learning Outcomes

At the end of this course, you will be able to:

  • Identify which study data are in scope for the SEND standard based on published domains.
  • Apply the SEND Trial Design concepts to model a nonclinical study design.
  • Identify where controlled terminology must be applied to data relevant for SEND.

Continuing Education Units (CEUs)

Learners will receive 1.4 CEUs for successfully completing this course.

Successful Course Completion

  1. In order for a learner to successfully complete a course:
    1. An education representative or learner will complete training registration.
    2. A learner must attend course for 80% of total course time. Specific attendance requirements are posted in course information pages.
    3. A learner will complete final course assessment with a score of at least 80% correct.
    4. A learner will complete summative assessment surveys
  2. Remediation: The following requirements will be in effect if learner does not successfully complete all parts of training:
    1. If learner registers for course but fails to complete formative assessment in required time, learner will be notified that they must transfer registration to later date.
    2. If learner completes formative assessment but does not meet attendance requirement, learner will be notified that they must re-attend course in full.
    3. If learner meets attendance requirement in full but fails content assessment, learner is given a maximum of two additional re-attempts before being required to re-attend the course in full. Learner will be notified and will receive a certificate of attendance after the third failed assessment attempt.
    4. If learner successfully completes content assessment but fails to complete summative assessment, learner will be notified and CEUs will be on hold until summative assessment is completed.
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: 
Biostatistician, Data Manager, Nonclinical Study Personnel, Programmer
Industry: 
Academic Institution, BioTech, Clinical Laboratory, Consulting, CRO, Government, Healthcare Provider, Medical Device, NPO, Pharmaceutical, Technology Service Provider, Other