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.
This course presents an overview of health economics and outcomes research studies. Principles of study designs are reviewed, including developing conceptual models and defining key variables. Three categories of outcome measures and three methods of data collection are also presented. The course concludes by discussing two common outcomes research study types: comparative effectiveness and health economics.