Good Clinical Practice (GCP) Practice Exam

What defines a Multicentre Trial?

1. A trial conducted according to multiple protocols

2. A trial performed at various sites under a single protocol

3. A trial limited to a single investigator at one site

4. A trial focused solely on laboratory-based assessments

The correct answer is: A trial performed at various sites under a single protocol

A multicentre trial is defined as a study that is conducted at various sites but follows a single protocol. This approach allows researchers to gather data from a diverse population across different geographical locations, which can enhance the robustness and generalizability of the trial's findings. By utilizing multiple sites, these trials can often recruit participants more quickly and efficiently, leading to a larger and more representative sample size. This structure is crucial in clinical research as it helps mitigate the variations that may arise from conducting a trial at a single location, including differences in population demographics, healthcare practices, and environmental factors. Therefore, the utilization of a single protocol across multiple centers ensures consistency in how the trial is executed and how data is collected, ultimately leading to more reliable results. Other options, such as conducting trials under multiple protocols or limiting the trial to one investigator at one site, do not align with the definition of a multicentre trial. Similarly, focusing solely on laboratory assessments does not encompass the broader scope of clinical trials, which often involve various types of assessments and interventions across different settings.