Yale University

 
Instructor-led Good Clinical Practice (GCP)
Description
 

The conduct of clinical trials involving investigational new drugs is subject to a highly regulated system of Good Clinical Practice (GCP) that is designed to ensure human subject protection, as well as preserve the accuracy and credibility of the clinical trial data. Failure to comply with these requirements can lead to varying degrees of consequences including damage to individual or institutional reputation, disqualification, debarment, fines, and even incarceration.

This course will provide participants with a detailed review of the Food and Drug Administration's (FDA) GCP regulatory requirements and expectations for individuals involved in the conduct of drug studies. Additionally, participants will acquire insight into some common pitfalls identified during these clinical investigations and how to avoid them. Course content will help prepare attendees for carrying out or reviewing compliance with those regulations and expectations.

Objective Audience
 
  •  
  • Understand and be able to identify the components of GCP.
     
  •  
  • Apply the principles and concepts of GCP to conduct a clinical trial successfully.
     
  •  
  • Understand the ramifications of a negative regulatory inspection and the possible enforcement actions.
     
  • Clinical Research Physicians
     
  • Clinical Research Nurses
     
  • Yale Faculty and Staff
     
  • Study Coordinators
     
  • Principal Investigators
     
  • Clinical Research Assistants
    Approval Required YCCI
    Delivery Type Instructor Led
    Fee None
     
       

    Upcoming Class Date(s)  

    Essentials: Essential Documents

    Thursday, February 3rd, 2022
    12:00 PM - 01:00 PM
     ZOOM, Meeting/Webinar
    Register for this Session
    Myself
    Others      
             
        Instructor(s) Brian Bennett
      Available Seats 44
      Refreshments
      Notes    
    Essentials: Study Conduct and Trial Monitoring

    Thursday, March 3rd, 2022
    12:00 PM - 01:00 PM
     ZOOM, Meeting/Webinar
    Register for this Session
    Myself
    Others      
             
        Instructor(s) Brian Bennett
      Available Seats 51
      Refreshments
      Notes    
    Audits and Inspections: Purpose, What to Expect, Consequences

    Thursday, April 7th, 2022
    12:00 PM - 01:00 PM
     ZOOM, Meeting/Webinar
    Register for this Session
    Myself
    Others      
             
        Instructor(s) Brian Bennett
      Available Seats 52
      Refreshments
      Notes    

    YCCI
    (203) 737-4623(Phone)
    yccitraining@yale.edu
    http://ycci.yale.edu/index.aspx

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