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

Investigators have commitments to the sponsor when participating in pharmaceutical company-sponsored clinical investigations because the sponsor is typically responsible for funding the trials, providing the investigational product, and overseeing the overall conduct of the study. The sponsor relies on the investigators to adhere to study protocols, ensure the integrity of the data collected, and report results accurately. This relationship necessitates clear communication and adherence to guidelines established by both the sponsor and regulatory frameworks.

While investigators also have obligations to the other entities mentioned—such as ensuring the safety and rights of subjects, adhering to the protocols approved by the Institutional Review Board (IRB), and complying with regulations set forth by the FDA—these commitments do not outweigh the primary relationship and obligations established with the sponsor, who is the source of resources for the clinical investigation. Thus, the responsibilities towards the sponsor are foundational and vital for the successful conduct of the trial.