Good Clinical Practice (GCP) Practice Exam

What does the term "investigator/institution" refer to?

1. The investigator working alone

2. The institution where trials are conducted

3. The investigator and/or institution as per regulatory requirements

4. The legal entity responsible for trial funding

The correct answer is: The investigator and/or institution as per regulatory requirements

The term "investigator/institution" is understood within the context of Good Clinical Practice (GCP) as referring to both the investigator and the institution involved in the clinical trial. This terminology encapsulates the roles and responsibilities defined by regulatory requirements that govern clinical research. In clinical trials, the investigator is typically a qualified individual who oversees the conduct of the study at the specific site, ensuring compliance with the protocol and GCP guidelines. The institution plays a crucial role as it provides the necessary infrastructure, resources, and support for conducting the study. Regulatory authorities require that both the investigator and the institution adhere to necessary ethical standards, safety protocols, and data integrity measures. Understanding this term's broad scope is essential to grasping the collaborative nature of clinical trials, where both entities have shared responsibilities for participant safety and study integrity. By recognizing that "investigator/institution" encompasses both parties as they align with regulatory expectations, one can better appreciate the framework of oversight that supports ethical and scientifically sound research practices.