Good Clinical Laboratory Practice

What Will You Learn?

• Core Principles: Deep understanding of the 13 core principles of GCP, including ethical conduct, medical care for subjects, and scientific validity.
• Roles & Responsibilities: Clearly defined obligations for investigators, sponsors, monitors, and Institutional Review Boards (IRBs).
• Informed Consent: The detailed process of obtaining and documenting voluntary participant consent.
• Regulatory Compliance: Navigating international and local laws, such as those from the US FDA and EMA.
• Safety Reporting: Protocols for identifying and reporting adverse events and managing risk during a trial.
• Data Integrity: Standards for recording, maintaining, and reporting trial data to ensure it is verifiable and transparent.
• Trial Documentation: Proper management of essential documents like the Investigator Site File and Trial Master File.