Identifying, Understanding, and Managing Patient Safety and Clinical Risks in the Clinical Research Environment

Lee, Laura M.; Henderson, David K.

Meticulous study design, exacting scientific review, scrupulous data management, rigorous human subjects' protection, and effective recruitment strategies are essential components of all clinical research studies that must be in place prior to the conduct of the study. Equally important to the success of the study and to the well-being and protection of study participants is the assurance that safe clinical environments are provided for the care of research participants. This chapter describes approaches to managing patient care and clinical research quality, as well as the application of established health care-based clinical quality methods and tools to the complex processes of clinical research. Techniques for identifying clinical risks, tools for collecting data about the quality of clinical care processes, strategies for mitigating risk and patient harm, and techniques for measuring the participants' perceptions of the research process are discussed in detail.