The Association of Clinical Research Professionals

Statistical Principles for Clinical Trials: Overview of ICH E9

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 training program 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.

Upon completion of this training program, participants should be able to:

  • 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.

This course helps clinical researchers of all types build competency in Data Management and Informatics and Scientific Concepts and Research Design. Explore Competencies >

Approved for 1.5 ACRP Contact Hours | Available 1 Year from Enrollment Date