Good Clinical Practice (GCP) Practice Exam

Good Clinical Practice Guidelines are applicable to which of the following?

1. Only trials conducted in hospitals

2. Any clinical investigations impacting human subjects' safety

3. Trials that are profitable

4. Only those sponsored by large pharmaceutical companies

The correct answer is: Any clinical investigations impacting human subjects' safety

Good Clinical Practice (GCP) Guidelines are designed to promote the safety and well-being of trial participants and ensure the integrity of clinical trial data. These guidelines apply to any clinical investigation involving human subjects, regardless of the setting, sponsor, or potential profitability of the trial. GCP is essential wherever human subjects are involved, which encompasses not just studies conducted in hospitals but also those held in outpatient settings, community clinics, and other environments. This broad applicability helps to create a universal standard for conducting clinical research and protects participants in all types of investigations, ensuring their rights and safety are prioritized. The other options fail to encompass the full breadth of GCP applicability. Some incorrectly limit GCP to specific study types, settings, or sponsors, which conflicts with the principle of safeguarding all human subjects in clinical research no matter the conditions or intentions behind the trials.