The Association of Clinical Research Professionals
ICH E9: A Review and a Look Into the Addendum (R1)
Join us for an overview of both the ICH E9 Guideline and the ICH E9 (R1) Addendum. The review will explore how clinical trials are based on statistical principles and how treatment effects are measured in a clinical trial.
This recorded webinar is split into two halves. The first half, titled “ICH E9: Introduction to Clinical Trial Statistics,” will be followed by a brief intermission, then the second half, titled “ICH E9(R1): Estimating Treatment Effects and Accounting for Data Vulnerabilities.”
Upon completion of this continuing education program, participants should be able to:
Understand how clinical trials are based on statistical principles
List basic clinical trial designs
Identify bias and data vulnerabilities (robustness)
Understand using blinding and randomization in a clinical trial
Understand how treatment effects are measured in a clinical trial
Understand how to define intercurrent events
Understand how to describe sensitivity analysis
List problems with missing clinical trial data
Speakers Dr. Joy Frestedt, BA, PhD, President and CEO, Frestedt Incorporated & Alimentix, the Minnesota Diet Research Center
Dr. Kasey Sands, PhD, MSN, RN, Clinical Regulatory Quality Engineering (CRQE) Specialist I, Frestedt Incorporated