Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Which international quality standard describes safety, accuracy of trials, and credibility of data?

1. Good Laboratory Practice (GLP)

2. Good Clinical Practice (GCP)

3. International Conference on Harmonisation (ICH)

4. Clinical Trial Registration Guidelines

The correct answer is: Good Clinical Practice (GCP)

The correct choice reflects the principles outlined in Good Clinical Practice (GCP), which is an international quality standard that focuses specifically on the ethical and scientific quality of clinical trials. GCP ensures that trials are conducted in a manner that safeguards the rights, safety, and well-being of trial participants. It also emphasizes the credibility and reliability of the data generated during clinical studies, ensuring that results are both accurate and trustworthy. By adhering to GCP guidelines, researchers are required to implement comprehensive processes for trial design, conduct, monitoring, auditing, recording, analyses, and reporting. This thorough approach is critical in maintaining the integrity of clinical research and ensuring that the results can support regulatory submissions for new drugs or therapies. The other options relate to different aspects of research and regulatory oversight. Good Laboratory Practice (GLP) primarily addresses the quality of non-clinical laboratory studies. The International Conference on Harmonisation (ICH) develops guidelines that may cover a range of areas, including aspects of GCP, but it is not itself a quality standard. Clinical Trial Registration Guidelines focus on the necessity to register clinical trials publicly, which promotes transparency but does not inherently cover the standards of safety and accuracy that GCP does.