Good Clinical Practice

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Welcome

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. The course is self-paced and takes approximately six hours to complete.

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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

• 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

Users 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 (a 100% passing option is available if required by your IRB). Upon successful completion of all quizzes, the user will be given access to the Certificate of Completion. Within the NIDA Clinical Trials Network, certification expires after three years.

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