Certified Clinical Research Associate (CCRA) Practice Exam 2026 – All-in-One Guide to Master Your Certification!

The sponsor-investigator holds a crucial dual role in clinical trials, and ensuring compliance with Good Clinical Practice (GCP) is essential throughout the study. GCP encompasses the standards set to ensure the ethical and scientific quality of clinical trials. This includes adherence to regulatory requirements, protecting the rights and welfare of participants, and ensuring the reliability of trial data. As both a sponsor and an investigator, this individual is responsible for overseeing all aspects of the trial, ensuring that it is conducted according to these rigorous standards.

While managing the budget, recruiting and training personnel, and developing the study protocol are important aspects of a clinical trial, they do not encapsulate the comprehensive responsibility that comes with ensuring GCP compliance. Budget management, personnel recruitment, and protocol development may involve collaboration with other stakeholders or might not fall solely under the sponsor-investigator's purview. However, adherence to GCP is non-negotiable and fundamental, as it impacts the validity of the trial outcomes and the safety of its participants.