Good Clinical Practice (GCP) Practice Exam

The process of randomization in clinical trials is fundamentally about using chance to assign subjects to different treatment or control groups. This method ensures that each participant has an equal opportunity to be assigned to any group, thus minimizing selection bias and enhancing the reliability of the results. Randomization helps in achieving comparability between groups, making it possible to attribute any observed effects directly to the intervention being tested rather than to pre-existing differences among participants.

This technique also supports the blinding process, preventing researchers and participants from knowing which group participants are in, which can further reduce bias in assessing outcomes. Randomization is crucial in maintaining the integrity of scientific evidence in clinical trials.

In contrast, assigning subjects based on medical history, matching them with similar characteristics, or solely collecting data from subjects do not capture the essence of randomization, as these processes can introduce bias and undermine the fundamental goal of equal treatment opportunity inherent to randomized assignments.