Investigator Responsibilities in Clinical Trials: Practical Applications of Good Clinical Practices

This 3 ½ hour short course is targeted at principal investigators who are responsible for providing oversight and ensuring that Good Clinical Practices are followed in their research studies. Attendees will learn best practices for how to handle issues that arise in the daily conduct of research studies and how to handle these issues in compliance with GCP. Attendees will also hear examples presented by UNC investigators who are responsible for implementing GCP in their own research projects.

Event details

When

Dec 09, 2011
from 08:30 AM to 12:00 PM

Where

Brinkhous-Bullitt, Room 219

Contact Name

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The objectives of this course are to:
• Define Good Clinical Practices (GCP)
• Describe the role and responsibility of the Investigator in the overall conduct of a study
• Discuss the FDA Form 1572 – Statement of Investigator
• Discuss audits and inspections of clinical trials
• Describe appropriate clinical trial staffing and delegation of responsibilities
• Review the informed consent process
• Describe appropriate management of study documentation

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