Good Clinical Practice (GCP) Practice Exam

Which of the following describes a clinical trial conducted under a single protocol?

1. A Multicentre Trial

2. A Phase I Trial

3. A Controlled Trial

4. An Open-label Trial

The correct answer is: A Multicentre Trial

A clinical trial conducted under a single protocol refers to a study that is being carried out across multiple sites or centers but still adheres to one unified design and set of procedures. This coordination ensures that participants at different locations are subjected to the same methodologies, interventions, and assessments, all contributing to the overarching study goals. In this context, a multicenter trial exemplifies this concept, as it involves enrolling participants from more than one site while maintaining consistency in the research protocol, which enhances the generalizability of the results and allows for a larger and more diverse participant population. Other types of trials mentioned, such as phase I, controlled, and open-label trials, may refer to specific aspects of clinical studies, like the focus on safety and dosage (phase I), the presence of a comparison group (controlled), or transparency regarding treatment assignment (open-label), but they do not inherently indicate that the trial is conducted under a single, unified protocol across multiple sites. Thus, while other trial types can exist in varied contexts, the definition of a clinical trial under a single protocol is most accurately described as a multicenter trial.