ICH-GCP training and Certification for Investigators and study site research personnel
The Good Clinical Practice (GCP) course is designed to prepare research staff in the conduct of clinical trials with human participants. The 12 modules included in the course are based on ICH GCP Principles and the Code of Federal Regulations (CFR) for clinical research trials in the U.S.A, EUROPE and ASIA.
Course Topics
• Introduction
• Institutional Review Boards
• Informed Consent
• Confidentiality & Privacy
• Participant Safety & Adverse Events
• Quality Assurance
• The Research Protocol
• Documentation & Record-Keeping
• Research Misconduct
• Roles & Responsibilities
• Recruitment & Retention
• Investigational New Drugs
Certification
Research professionals are required to complete a quiz following each module, except for the Introduction module. To receive a certificate, all quizzes must be completed with at least 80% accuracy. Upon successful completion of all quizzes, the user will be given access to the Certificate of Completion.