Good Clinical Practice
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Table of Contents
Table of Contents
This course provides educational information and does not replace professional medical advice, diagnosis, treatment, or clinical judgment.
Clinical research has transformed modern medicine, but flawed studies can harm patients and waste resources. Good Clinical Practice (GCP) provides the ethical and scientific framework that ensures trial data are credible and participant rights are protected.
What You Will Learn
- 1 Understand the historical evolution and core principles of Good Clinical Practice (GCP) and its global impact on clinical research.
- 2 Learn the ICH GCP guidelines, regulatory framework, and key international agencies governing clinical trials.
- 3 Understand ethical foundations: informed consent, IRB/IEC, and protection of human subjects.
- 4 Analyze the roles and responsibilities of sponsors, investigators, and monitors in clinical trials.
- 5 Apply principles of clinical trial documentation, source data, and record retention per GCP.
- 6 Understand safety reporting: adverse events, serious adverse events, and pharmacovigilance in clinical trials.
- 7 Implement monitoring and auditing processes to ensure protocol compliance and data integrity.
- 8 Explore quality assurance and quality control systems in clinical research.
- 9 Understand data management, handling, and integrity including electronic data capture and validation.
- 10 Explore emerging trends: decentralized trials, digital health technologies, and regulatory updates in GCP.
What's Included
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Good Clinical Practice