Good Clinical Practices (GCPs): Impact on the role of a CRC

Phase I, II, III, and IV Study Highlights

Roles and Responsibilities of the Coordinator, Principal Investigator, Sponsor, and Monitors

Understanding Basic Regulatory Requirements

Confidentiality and Privacy Issues: Protecting Human Subjects

The Informed Consent Process

Source Documentation Practices that Will Survive Any Audit

Adverse Events: Expected, Unexpected, Serious, Reportable?

Organization of Protocols and Subject Information

Drug/Device Accountability: How to Prevent Mistakes

Recruitment Strategies that Work

Research Pitfalls and How to Avoid Them

Upon completion of this course, participants will be better able to:

Describe FDA regulations regarding research subjects

Outline good clinical practice guidelines

Define the roles and responsibilities of research professionals

Demonstrate the organizational skills necessary to maintain good clinical research practices

Review and report adverse events and serious adverse events

Apply good documentation practices

Explain the importance of data integrity and audits