Course Description

The roles and responsibilities of the Principal Investigator (PI) are essential for quality data and regulatory compliant clinical trials, but the PI remains an under-trained position in the industry. Because of the critical role the PI plays during a clinical trial, there is debate within the industry of mandatory certification for the PI and/or site accreditation. Documentation of industry training is essential. This web seminar reviews the clinical trial core competencies required for the Principal Investigator in accordance with the federal regulations, ICH GCP guidelines, and industry best practices.

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Learning Objectives

• Recognize GCPs and the responsibilities of the Principal Investigator
• Examine protocol content
• Identify essential documents and the regulatory binder
• Define source documentation
• Examine informed consent and HIPAA authorization
• Examine sponsor visits and reports
• Explain investigational product management
• Define safety reporting and Adverse Event documentation
• Discuss FDA audits
• Apply tools and resources

Who Should Attend

• Physicians and others interested in getting involved in research
• Experienced Principal Investigators or Site Personnel looking to take an industry investigator certification exam

Instructor

The course will be led by one of the following instructors:

Gary B. Freeman, M.S., C.C.R.A.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.