GCP Training
What is GCP Training?
GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials involving human subjects.
Why GCP Training?
- Ethical Principles
- Ensures clinical trials comply with ethical principles outlined in the Declaration of Helsinki and other key documents.
- Safeguards participants’ rights and dignity.
- Quality and Credibility
- Provides a framework for conducting trials that produce credible and accurate data.
- Reduces errors and ensures consistency across studies.
- Regulatory Compliance
- Compliance with GCP is mandatory for regulatory approval by agencies like the FDA, EMA, and others.
- Non-compliance can lead to fines, disqualification, or invalidation of study results.
Core Principles of GCP
- Protection of Participants: The well-being of participants takes precedence over the interests of science or society.
- Informed Consent: Participants must provide voluntary and informed consent.
- Scientific Validity: Trials should be scientifically sound and described in a clear, detailed protocol.
- Oversight by IRB/IEC: Independent review boards (IRBs) or ethics committees (IECs) must oversee and approve the trial.
- Qualified Personnel: Investigators and staff must be appropriately qualified.
- Data Integrity: Accurate, complete, and verifiable data must be recorded.
- Compliance with Protocol: Trials must strictly adhere to the approved protocol.
- Risk-Benefit Assessment: Risks to participants must be minimized and justified by the anticipated benefits.
Course Highlights
- Fully Online – Learn at your own pace
- ICH-GCP Compliant – Covers the latest E6 (R2) guidelines
- Certification Included – Download your certificate instantly
- Interactive Modules – Engaging quizzes and real-world examples