This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Course Description:

This Investigator Good Clinical Practice (GCP) course takes the requirements of GCP for clinical trials found in ICH E6 GCP related to the role of the investigator working on a clinical trial for a sponsor/CRO. The required activities related to the investigator GCP roles and responsibilities are presented with case studies to reinforce key concepts and emphasize critical activities that if not performed well or delegated appropriately for a study, can be increase risk toward maintaining protection of human subjects and ensuring data integrity. 

This course is interactive, including pre and post-course knowledge assessments. Certificates of completion are provided.

Session Objectives:

• Define GCP and key stakeholders, sponsor/CRO, investigator and delegates, and ethics committees
• Apply the GCP requirements to the roles of investigators, monitors, sponsors/CROs, and ethics committees per ICH GCP
• Recognize the changes in the 2015 updates to ICH E6 GCP for the role of the investigator and sponsor
• Identify and apply regional GCP requirements when performing sponsor and investigator roles in clinical trials
• Discuss GCP activities that support investigator audit readiness for supporting quality clinical trials and human subject protection