Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

The Investigator holds ultimate responsibility for the accountability of all investigational products in a study. This role involves ensuring that all investigational products are stored, handled, and utilized according to regulatory requirements and the study protocol. The Investigator must maintain proper records of product receipt, usage, and disposal, thereby ensuring integrity and compliance throughout the study.

This accountability is essential because the Investigator is directly involved in the clinical trial and has firsthand knowledge of how the investigational products impact study participants. They are tasked with ensuring that all ethical standards are met and that the study is conducted in accordance with Good Clinical Practice (GCP) guidelines. Ultimately, the integrity of the trial results and participant safety depend on the Investigator's oversight of the investigational products.

While the Sponsor plays a critical role in providing the investigational products and supporting the study, and the Study Coordinator assists in managing day-to-day operations, it is the Investigator who is legally and ethically responsible for the products' proper management. The Regulatory Affairs Officer contributes to ensuring compliance with regulations but does not hold the ultimate responsibility for the investigational products during the study.