chapter  6
16 Pages

Collaborating for Compliance and Quality Data—Monitoring and Audits

The ultimate goal of drug and device development is to bring safe and effective medical products to the public. This requires dedicated expertise and oversight throughout the process to ensure that the “proof” of safety and effectiveness meets the standards of scientific integrity, while maintaining ethical principles. During the trial clinical process, regulations require sponsors (or their representatives) to monitor research sites for quality data and regulatory compliance. At the same time, the research team may conduct internal quality management reviews to ensure continuous quality data standards, and the (approving) institutional review board (IRB), the Food and Drug Administration (FDA), and other internal and external organizations may audit research sites for scientific, ethical, and/or regulatory reasons.