Overview of Clinical Research

COURSE DESCRIPTION

This course will provide information on many aspects of clinical research. This includes scientific process, research protocol, documentation, regulatory documents, adverse event classification, and reporting events to regulatory bodies. Record retention, drug accountability and study closure are also discussed.

TARGET AUDIENCE

This course is intended primarily for healthcare workers and teams in a biocontainment unit environment. Additional medical staff and public health professionals may also find the course to be of benefit. Those individuals may include, but are not limited to, medical and/or nursing staff, administration, education/training leadership, and infection control leadership. Staff specializing in communications, specialized clinical areas, laboratory, facilities management and environmental services are also welcome.

LEARNING OBJECTIVES

At the conclusion of this activity, the participant should be able to:

• Identify key aspects in the conduct of clinical research
• Recognize the importance of maintaining essential documents required for conducting research
• Interpret standard data that is collected during clinical trials