Our team of professionals is dedicated to supporting the research community through Quality Reviews for human subject research, Clinical Trial Disclosure support and oversight, Corrective and Preventive Action management and educational training sessions. Our goal is to facilitate continuous quality improvement in the protection of our research participants and the integrity of data. Quality is our primary endpoint.
RQA conducts internal Quality Reviews of human subject research conducted at the University of Miami. Medical research studies, as well as social-behavioral studies,
may be reviewed by RQA. These reviews are intended to assess the research teams' level of adherence to Federal and State regulations and guidelines, University policies and procedures, as well as to provide guidance and recommendations to improve research practices.
RQA provides support to the University of Miami research community in the creation, development, implementation, and follow-up of CAPA Plans. These CAPA Plans are created to identify, remediate and prevent recurrence and occurrence of existing or potential causes of non-compliance or other quality issues.
GxP is a general term used to represent the FDA regulations governing Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice, as well as Electronic Records and Electronic Signatures. GxP Compliance refers to the compliance of the many processes implemented and executed as part of the research practices that are subject to these regulations. The conduct of FDA-regulated human subject research at the University involves the complex interaction of many federal and state regulations as well as internal institutional policies that govern human subject research.
