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 the basic principles of clinical research that provide the foundation for good study design. The first lesson provides an overview of clinical research and the protocol, which is the written plan for the study. Each of the remaining lessons focuses on clinical research principles that are key to developing a good study plan, including formulating study objectives, selecting appropriate study subjects, selecting appropriate measures, and developing a data analysis plan.