Research Compliance and Quality Assurance (RCQA)

RCQA

Our team of professionals is dedicated to supporting the research community through Quality Reviews of 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.


Quality Assurance (QA)

RCQA 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 RCQA. 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.

Corrective and Preventive Actions (CAPA)

RCQA 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.

Clinical Trial DIsclosure (CTD)

Clinical Trial Disclosure (CTD) RCQA created processes and procedures to assist our researchers and their teams in achieving and maintaining adherence with many of the CTD requirements. We offer a university-wide training program, including the basics of CTD related regulations and requirements, in addition to providing one-on-one support for Trial Registration and Result Reporting on https://register.clinicaltrials.gov  https://register.clinicaltrials.gov  RCQA has also established a university-wide system/database to obtain tracking and metrics of trial registration and result reporting.