What is the overall goal of monitoring, audits, and inspection activities?

The overall goal of monitoring, audits, and inspection activities is fundamentally centered around ensuring the protection of human research subjects and maintaining the integrity of data collected during clinical trials. This aspect is crucial in clinical research, as it upholds ethical standards and safeguards the rights and well-being of participants involved in studies. Protecting human subjects involves ensuring that informed consent is obtained, that risks are minimized, and that participants are treated ethically throughout the research process.

Additionally, data integrity is vital because accurate and reliable data is necessary for evaluating the safety and efficacy of a treatment or intervention. By focusing on both human subject protection and data integrity, monitoring and auditing processes help to ensure that clinical research is conducted in accordance with Good Clinical Practice (GCP) guidelines, regulatory requirements, and institutional policies. This comprehensive approach fosters trust in the research outcomes while ultimately advancing medical knowledge and improving patient care.