Good Clinical Practice ICH-GCP R3 for Clinical Investigators

Identify the core roles in a clinical study from participants to ethics committees, sponsor, investigator, and service providers, and clarify responsibilities, approvals, and delegation.

Learn the key processes in a clinical study, including informed consent in three steps, serious adverse event reporting, monitoring, and audits and inspections by sponsors and regulators.

Explore key essential documents in clinical trials, including the investigator's brochure, protocol, and clinical study report. Learn how data acquisition tools, source records, and formal agreements underpin compliant research.

Explore the 11 overarching ich-gcp principles and apply flexible, risk-based, quality-by-design thinking to clinical trial design, innovation, and mitigation across the lifecycle and diverse populations.

This lecture outlines the 11 ich gcp principles for investigators, emphasizing patient rights, informed consent, ethics oversight, quality by design, and safe investigational product handling.

Qualify the investigator by education, training, and CV evidence, collaborate with investigators specialized in the indication, and train on product-specific use per protocol approved by ethics committee.

Ensure adequate resources by estimating recruitment capacity, securing qualified staff and facilities, planning sufficient trial time, and maintaining transparency with the sponsor about equipment needs and the contract.

Submit the trial protocol, informed consent materials, recruitment procedures, participant information, and investigator brochure to ethics committee for approval before starting, then provide documented updates and promptly report any changes.

Investigators must conduct trials in compliance with the protocol, document deviations with the sponsor, and review and prevent recurrence; for immediate hazards, inform sponsor, ethics committees, and regulators, propose amendments.

Ensure ethics committee approval for informed consent materials and process. Conduct the consent with clear, simple language, no coercion, and time to ask questions.

Learn how to manage investigational products with accountability for delivery, inventory, use, return, and destruction. The investigator remains responsible, may delegate to a pharmacist, and must record essential data.

Learn how to ensure data integrity with source records and compliant reports, apply Alcoa principles, protect privacy, and maintain audit trails throughout the trial lifecycle.