Good Clinical Practice (GCP) Practice Exam

Who conducts inspections related to clinical trials?

1. The investigational product manufacturer

2. Regulatory authorities

3. The principal investigator

4. Independent review boards

The correct answer is: Regulatory authorities

Inspections related to clinical trials are primarily conducted by regulatory authorities. These authorities, which can include organizations like the Food and Drug Administration (FDA) in the United States or similar entities in other countries, have the responsibility to ensure that clinical trials comply with applicable laws and regulations. Their inspections assess factors like data integrity, participant safety, and adherence to Good Clinical Practice (GCP) guidelines. This oversight is crucial for maintaining public trust in the clinical trial process and ensuring that the results generated from these trials are credible and reliable. Regulatory authorities focus on examining the protocols, informed consent processes, data management practices, and overall ethical conduct of the trial. By conducting inspections, they help protect trial participants and ensure that the investigational products are developed in a scientifically sound and ethical manner. The other options represent important players in the clinical trial process but do not typically conduct inspections. For instance, the investigational product manufacturer is involved in producing the test products while the principal investigator is responsible for overseeing the trial at the site level. Independent review boards (also known as Institutional Review Boards or IRBs) review the trial protocol and participant consent but do not carry out regulatory inspections.