The Association of Clinical Research Professionals

Theory to Practice: Operationalize Your Clinical Study Protocol

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Member: $189 | Non-Member: $239

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This course is approved for 1.5 ACRP contact hours. Accreditation Details

This eLearning course will be accessible for up to one year from the date of purchase.


Course Description

What use is a protocol that does not appropriately capture data to support meaningful statistics? Why are study design, conduct and data analysis so important to consider at the protocol development stage?

This eLearning course explores the International Conference on Harmonization’s E9 guideline Statistical Principles for Clinical Trials. Improve protocol interpretation and implementation by understanding trial scope, design, conduct, data analysis, and the evaluation and reporting of safety and tolerability data.

This course is ideal for those newer to the field of clinical research who need to understand protocol development and protocol content and also benefits those preparing for an ACRP examination who need to brush up on their knowledge and application of ICH E9.

Learning Objectives

  • Summarize the considerations for overall clinical trial development
  • Explain the different design configurations
  • Describe the considerations for trial conduct and data analysis
  • Explain how safety and tolerability is evaluated
  • Summarize trial reporting requirements

Competency Domains

This course builds competence in the following domains:

  • Data Management and Informatics
  • Scientific Concepts and Research Design

Learn About Competency Domains for Clinical Research Professionals >>

Audience

All clinical research professionals.