Clinical Research Education Series (CRES) | “The Intersection Between Clinical Research Approvals and Safety Committee Reviews and Approvals: Encore Presentation"

January 31, 2025

This encore presentation will provide a brief overview and education of the Intersection Between Clinical Research Approvals and Safety Committee Reviews and Approvals Process. For those who missed the original presentation, we will recap and discuss information regarding regulatory approval pathway for clinical investigations, describe how and where the Safety Committees and IRB reviews intersect, outline regulatory reporting requirements for noncompliance as well as other useful information! 

Target Audience

Employees at Houston Methodist Hospital Research Institute 

Learning Objectives

Participant Learning Outcomes:

  • Delineate the regulatory criteria that govern clinical investigations involving biologics, chemicals or radioactive materials and radiation emitting devices.
  • Describe the regulatory approval pathway for clinical investigations involving biologics, chemicals or radioactive materials and radiation emitting devices.
  • Describe how and where the Safety Committees and IRB reviews intersect.
  • Outline the regulatory reporting requirements for noncompliance  with the regulations.

 

Course summary
Available credit: 
  • 1.00 Attendance
Course opens: 
12/27/2024
Course expires: 
02/01/2025
Event starts: 
01/31/2025 - 12:00pm CST
Event ends: 
01/31/2025 - 1:00pm CST
Add to calendar: 
Virtual Meeting
Houston, TX
United States

Virtual - ZOOM link with be provided to the registered participants.

Presenter(s) Info:

  • Malissa Mayer-Diaz, MS, MSPH

  • Marion Olson 

1.00 Attendance

Available Credit

  • 1.00 Attendance
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