The Association of Clinical Research Professionals

​​Statistical Principles for Clinical Trials Overview of ICH E9 and ICH E6(R3)​

Statistical principles are fundamental to the design, conduct, interpretation, and reporting of clinical trials.

This 90-minute, self-paced course introduces core concepts from ICH E9 and ICH E9(R1) and explores how these principles are applied in practice through the risk-based, quality-focused approach emphasized in ICH E6(R3). 

Designed for non-statisticians, the course focuses on practical understanding rather than mathematical detail. Learners examine key concepts such as variability and uncertainty, bias, randomization and blinding, hypothesis testing, and analysis strategies, as well as how treatment effects are defined using estimands. 

The course also explores how intercurrent events and missing data are addressed, why sensitivity analyses are essential for evaluating robustness, and how trial conduct and documentation decisions influence data integrity and the credibility of trial conclusions. By the end of the course, learners are better equipped to support high-quality, interpretable clinical trials aligned with current regulatory expectations.

At the end of this course, participants should be able to:

  • Explain how statistical principles underpin the design, conduct, analysis, and reporting of clinical trials in accordance with ICH E9.
  • Describe how trial design elements such as variability, randomization, blinding, and analysis strategies influence the interpretation of treatment effects.
  • Explain how trial conduct, documentation, and risk‑based approaches under ICH GCP E6(R3) support data integrity and statistical robustness.
  • Describe how treatment effects are defined and evaluated, including the role of estimands, intercurrent events, missing data, and sensitivity analyses in ICH E9(R1).
  • Explain how statistical considerations support the evaluation and transparent reporting of trial results, including safety data and data vulnerabilities, in regulatory submissions and clinical study reports.

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