Instructor-led Good Clinical Practice (GCP) - Audits and Inspections: Purpose, What to Expect, Consequences
The conduct of clinical trials involving investigational new drugs is subject to a highly regulated system of Good Clinical Practice (GCP) that is designed to ensure human subject protection, as well as preserve the accuracy and credibility of the clinical trial data. Failure to comply with these requirements can lead to varying degrees of consequences including damage to individual or institutional reputation, disqualification, debarment, fines, and even incarceration.
This course will provide participants with a detailed review of the Food and Drug Administration's (FDA) GCP regulatory requirements and expectations for individuals involved in the conduct of drug studies. Additionally, participants will acquire insight into some common pitfalls identified during these clinical investigations and how to avoid them. Course content will help prepare attendees for carrying out or reviewing compliance with those regulations and expectations.
- Understand and be able to identify the components of GCP.
- Apply the principles and concepts of GCP to conduct a clinical trial successfully.
- Understand the ramifications of a negative regulatory inspection and the possible enforcement actions.
- Brian BennettGCP Instructor