The Principles of Clinical Research and Protocol Design program consists of a series of four courses, which together provide a foundation in the essential elements of well-constructed clinical research protocols and how these elements are applied in clinical trials and observational studies.
The goals of the training are to provide learners with knowledge and skills to increase their ability to:
• Understand interventional and non-interventional clinical studies with an emphasis on meeting business needs.
• Develop and/or review protocols for local clinical evaluation (LCE) studies and investigator-initiated studies (IIS).
Develop and submit quality protocols.
Course Overview
This course presents an overview of epidemiology research studies. Nine types of study designs used in epidemiology studies are reviewed, discussing the advantages and limitations of each type of study design, and the situations in which each of the study designs is used. Also discussed in this course are the measures used in epidemiology studies and how to minimize chance, bias, and confounding in these types of studies. The course concludes with features of a good epidemiological protocol.