Good Clinical Practice Training

Good Clinical Practice Training (GCP) is critical to conducting research of the highest ethical standards and scientific quality. Most industry sponsored research requires this training for faculty and staff prior to initiating trials. Yale Cancer Center Clinical Research personnel who conduct research with human subjects are required to complete this training. To assist with completion of this training, the YCCI offers Good Clinical Practice Training in various formats for Yale clinical research faculty and staff.


Online Training

Yale University uses the web-based module provided by the Collaborative Institutional Training Initiative (CITI) for Good Clinical Practice (GCP) training. The Quality Assurance and Training Office is responsible for tracking module completion. To get started, click here.

Required Modules

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices 
  • Overview of New Drug Development 
  • Overview of ICH GCP 
  • ICH - Comparison Between ICH GCP E6 and U.S. FDA Regulations 
  • Conducting Investigator-Initiated Studies According to FDA Regulations and GCP 
  • Investigator Obligations in FDA-Regulated Clinical Research 
  • Managing Investigational Agents According to GCP Requirements 
  • Overview of U.S. FDA Regulations for Medical Devices 
  • Informed Consent 
  • Detecting and Evaluating Adverse Events 
  • Reporting Serious Adverse Events 
  • Audits and Inspections of Clinical Trials 
  • Monitoring of Clinical Trials by Industry Sponsors 
  • Records-Based Research 
  • Genetic Research in Human Populations 
  • Completing the CITI GCP Course 

The Yale Center for Clinical Investigation also sponsors GCP Training with a live instructor through GCP Training LIVE!. This course is offered to Yale clinical research personnel that are new to the topic of Good Clinical Practice as well as those who need a refresher course. To view upcoming training and education opportunities, click here.


Essentials for Clinical Research Professionals

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 is designed to provide participants with an overview 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. 

Review for Clinical Investigators and Research Professionals

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 is designed to provide participants with a review of the essentials pertaining to 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.