Who is primarily responsible for supplying the investigational product to investigator sites?

Prepare for the ICH Good Clinical Practice (GCP) Exam for Certified Clinical Research Coordinator with engaging multiple-choice questions and detailed explanations. Elevate your understanding and expertise to excel in your certification exam!

Multiple Choice

Who is primarily responsible for supplying the investigational product to investigator sites?

Explanation:
The main idea is who handles the IP supply chain for a trial. In GCP, the sponsor is responsible for supplying the investigational product to investigator sites. This includes manufacturing or procuring the IP, labeling it appropriately, shipping it under proper conditions, and ensuring there are systems for storage, inventory, accountability, and tracking. The investigator site receives the IP from the sponsor (or a designated distributor) and dispenses it to participants according to the protocol, while maintaining records and handling returns or destruction as required. IRB/IEC oversight and regulatory authorities have roles in approval and compliance, but they do not provide the IP to sites.

The main idea is who handles the IP supply chain for a trial. In GCP, the sponsor is responsible for supplying the investigational product to investigator sites. This includes manufacturing or procuring the IP, labeling it appropriately, shipping it under proper conditions, and ensuring there are systems for storage, inventory, accountability, and tracking. The investigator site receives the IP from the sponsor (or a designated distributor) and dispenses it to participants according to the protocol, while maintaining records and handling returns or destruction as required. IRB/IEC oversight and regulatory authorities have roles in approval and compliance, but they do not provide the IP to sites.

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