North Texas Chapter: FDA Inspection of Clinical Investigators

When:  Mar 25, 2023 from 09:00 AM to 11:00 AM (CT)
Associated with  ACRP North Texas Chapter

North Texas Chapter: FDA Inspection of Clinical Investigators 

Event Description: 

The Clinical Investigator Inspections presentation will provide an overview of the responsibilities of the Clinical Investigator related to Good Clinical Practices and subject protection regulations. It will also discuss the kinds of study records and regulatory submissions reviewed by the FDA investigator during the inspection. It will highlight some examples of 483 items cited and share tips on how to improve overall study conduct.


  • Michelle Hines, MS, RD, Supervisory Investigator/ Regulatory Officer, FDA/Office of Regulatory Affairs/Office of Tobacco and Medical Products/Division of Bioresearch Monitoring II, Dallas, Texas

Event Learning Objectives:

  1. Understand the Clinical Investigator (CI) obligations related to Good Clinical Practices (GCPs) and human subject protections.​
  2. Review the overall expectations related to study documentation.​
  3. Identify common deficiencies cited during inspections and share best practices for a successful FDA inspection.

Event Agenda:

8:30 - 9:00 a.m., CT:  Login and ensure connectivity
9:00 - 11:00 a.m., CT:  Presentation, Q&A

Registration Information:

Click here to register for the event.

  • Chapter Members: $5
  • ACRP Members: $15
  • Non-Members: $30

Contact Hour Information:

Click here to purchase contact hours. Please purchase and retrieve your contact hours before April 25, 2023

  • Chapter Members: $0
  • ACRP Members: $15
  • Non-Members: $30

To receive contact hours: Purchase the contact hours and attend the program. After attending the event, log on to the ACRP website and visit, click “GO TO MY COURSE”. Select your event, confirm attendance and take the event evaluation between 1 and 30 days following the event and obtain the online certificate." After 30 days, contact hours are no longer available


Dial-in Instructions: