Offerings

Description: This course module is designed to introduce the basic concepts necessary to understand the origin, mechanics, and implications of Regression to the Mean.  The course is built through graphical presentation of simulated data to minimize reliance on formulas and maximize visual learning.  The course demonstrates the impact of variability, poor correlation, and subset selection on Regression to the Mean as well as patterns that may lead to bias when Regression to the Mean interacts with ceiling or floor effects.

Length: 2 hours

eSource and Study Conduct: The Tangled Web
Description: This course module is designed to orient clinical trial professionals to the unique potential, but also unique challenges, of electronic source documents and data.  The course builds on the regulatory requirements and GXP guidance that are common to paper source documents and eSource, outlines the responsibilities of different clinical trial roles, and identifies specific practices that set a company's risk profile.

Length:1- 2 hours

Navigating the FDA Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Guidance
Description: This course module is designed to introduce the critical elements of the guidance, identify the implications for the target product profile, and link the patient to potential product claims.  The course builds on the December 2009 guidance and reviews industry experience and regulatory outcomes.

Length:1- 2 hours