What differentiates "Good Clinical Practice" (GCP) from "Good Laboratory Practice" (GLP)?

What differentiates "Good Clinical Practice" (GCP) from "Good Laboratory Practice" (GLP)?

• A. GCP applies to laboratory settings for non-clinical studies
• B. GCP includes regulations for data management, while GLP does not
• C. GCP applies to clinical trials involving human participants, while GLP applies to laboratory settings for non-clinical studies
• D. GCP is broader and includes all types of research

Answer: (C)

The distinction highlighted in the correct answer emphasizes that Good Clinical Practice (GCP) specifically pertains to the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human participants. This regulatory framework ensures the safety, integrity, and rights of participants in clinical research, as well as the validity of the data generated from these studies. In contrast, Good Laboratory Practice (GLP) is focused on non-clinical laboratory studies, particularly those intended for regulatory submissions. GLP sets forth a framework to ensure the quality and integrity of data in laboratory settings, but its scope is limited to the laboratory quality systems, emphasizing the conduct of non-clinical safety studies. The other options do not accurately capture the primary differentiation between GCP and GLP. For instance, while GCP does involve data management, it is not exclusive to that domain, and both GCP and GLP have regulations regarding data management appropriate to their respective settings. Similarly, GCP is defined by its application in clinical environments, making statement about its broader applicability misleading. Recognizing this clear boundary based on the types of studies and participants for which each guideline applies is key to understanding their foundational principles.

The distinction highlighted in the correct answer emphasizes that Good Clinical Practice (GCP) specifically pertains to the ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human participants. This regulatory framework ensures the safety, integrity, and rights of participants in clinical research, as well as the validity of the data generated from these studies.

In contrast, Good Laboratory Practice (GLP) is focused on non-clinical laboratory studies, particularly those intended for regulatory submissions. GLP sets forth a framework to ensure the quality and integrity of data in laboratory settings, but its scope is limited to the laboratory quality systems, emphasizing the conduct of non-clinical safety studies.

The other options do not accurately capture the primary differentiation between GCP and GLP. For instance, while GCP does involve data management, it is not exclusive to that domain, and both GCP and GLP have regulations regarding data management appropriate to their respective settings. Similarly, GCP is defined by its application in clinical environments, making statement about its broader applicability misleading. Recognizing this clear boundary based on the types of studies and participants for which each guideline applies is key to understanding their foundational principles.