CDISC Training

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CDISC-Authorized Education Courses

Business & Decision Life Sciences is an European CDISC SDTM, CDASH and Global Approach trainer for both public and private courses. Our trainers are qualified industry experts who have passed the CDISC qualification process and are members of the CDISC Education team.

The trainings are organized by CDISC using the official training materials and trainees will receive a certificate of training.

 

CDISC SDTM

(Study Data Tabulation Model) Course

CDISC CDASH

(Clinical Data Acquisition Standards Harmonization)

Course

CDISC Global Approach to Accelerating Medical Research Course

The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications.

The CDASH standard describes the basic data collection fields that are common to all therapeutic areas and all types of clinical research.

CDISC has collaborated with numerous other organizations on a global basis to analyze research regulations and processes. Through these collaborations and the work of thousands of volunteers worldwide over the past 14 years, a set of enablers that can recognizably accelerate the medical research process, from protocol through analysis and reporting has emerged.

Course Description and Learning Objectives

This class consists of:

  • A detailed review of SDTM concepts, SDTM domain models, and relationship tables
  • A discussion of common implementation issues
  • A workshop with CRF-annotation exercises that reinforce attendees' understanding of the SDTM and the SDTM implementation guide.

The audience will learn:

  • The theory behind SDTM and the format of data that will be required for submission to the FDA.
  • Key SDTM concepts.
  • How to represent various types of collected data in the SDTM format.

This course discusses:

  • Purpose and basic concepts of the CDASH standard
  • Relationship between CDASH and the other CDISC standards
  • Conformance rules for CDASH implementations
  • Challenges of collecting data in de-normalized structures
  • CDASH Best Practice recommendations for data collection.

The audience will learn:

  • The theory behind CDASH.
  • Basic principles of the CDASH Standard Model, as presented in the CDASH implementation guide.

This course outlines these enablers so that you can:

  • Understand the benefits of implementing them
  • Demonstrate how you can improve your data quality
  • Streamline workflow at investigative research sites and sponsoring organizations
  • Understand and communicate relevant business information that demonstrates the real world value of CDISC.

 

SDTM Training Program

(2 days)

CDASH Training Program

(1 day)

Global approach Training Program

(1/2 day)

DAY 1:

  • CDISC mission
  • Background on CRT (Case Report Tabulation) and FDA guidances
  • SDTM history and maintenance process
  • FDA Critical Path Initiative
  • SDTM basic concepts
  • Introduction to SDTM general classes and special purpose models
  • Screen shots of SDTM reviewer tools
  • Model concepts and terminology
  • Detailed review of general observation classes
  • Core model assumptions
  • SDTM metadata model
  • SDTM standard domains
  • Creation SDTM custom domains

 

DAY 2:

  • Principles of RELREC and SUPPQUAL for storing relationships between datasets, variables, and observations
  • Trial Design concepts

 

  • Enabling Collaboration
  • CDISC Organization Overview
  • Business Case for Standards
  • Non-Technical Standards Overview
  • Data Lifecycle – End to End Use
  • CDISC Strategic Direction

 

 

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