Chicagoland Chapter: FDA Bioresearch Monitoring Inspections: Clinical Investigators

Chicagoland Chapter: FDA Bioresearch Monitoring Inspections: Clinical Investigators

Program Agenda:
6:00-6:45 - Educational Presentation
6:45-7:00 - Q&A

Program Description: Jeanne Thai, MPA, a Certified Clinical BIMO investigator will discuss FDA Biomonitoring Research Monitoring Inspections for Clinical Investigators.

Learning Objectives:
1. Understand the Authority, Purpose and Scope of FDA Inspections of Clinical Investigators
2. Understand the Clinical Investigator (CI) obligations in Good Clinical Practice and Human Subject Protection regulations
3. Identify Most Common Deficiencies cited during FDA Inspections
4. Identify possible Enforcement Actions

Target Audience: 

• CRCs
• CRAs
• Investigators
• Auditors

Registration Cost: $0 for Chapter Members and ACRP members, $20 for non-members

Contact Hour cost (this cost is in addition to the event registration fee):

• ACRP Chicagoland Chapter Members = Free
• ACRP Members = $15.00
• Non ACRP = $30.00

Registration will include both any registration fee as well as the contact hour cost, as needed.

Refund Policy: No refunds

Level: Not specified

**If you register and receive a cancellation, please email chicagolandacrp@gmail.com with your invoice number so we can send you the zoom link.