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.
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.
- 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.