About Quality Assurance

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Quality Reviews 

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.

Our team of auditors conduct these Quality Reviews in a friendly, collegial, and collaborative manner, as these are intended as a service to the university’s research community.

RCQA conducts four (4) types of internal reviews, all of which are authorized by the Vice Provost for Research. 

RCQA  Quality Reviews

Investigator-Requested

Investigators may contact RCQA to request any of the following:
1.  Study Start-Up Review:  These reviews are recommended for inter-departmental/translational research studies, as well as for new investigators/research teams.  These will consist of a review of the study teams' processes, forms, etc. prior to enrollment of the first subject.  A report with recommendations will be issued to the investigator and their teams only.  
These reviews are intended for studies that are not internally or externally monitored.
2.  Study Review:  These reviews will consist of a review of studies already in progress with at least one subject enrolled. A report with recommendations will be issued to the investigator and their teams only.
These reviews are intended for studies that are not internally or externally monitored.

3.  Mock FDA Audit: An Investigator may request a Mock FDA Audit, where RCQA will conduct the audit to mimic an FDA inspection.   A report with recommendations will be issued to the investigator and their teams only.

*Above listed services will be provided in limited quantity on a first-come first-serve basis. 

Routine

Selected by RCQA using a risk-based approach. See Study Selection
 

Focused

May be Routine or Directed Quality Reviews.  These reviews are focused on a particular aspect of the clinical research such as the informed consent process, dispensation of investigational product, etc.

Directed

“For Cause” Quality Reviews are requested based on identified concerns about human subject safety, rights, regulatory compliance or data integrity.
  • These reviews are requested by committees or individuals, including but not limited to the IRB, Vice Provost for Research, Associate Vice Provost for Human Subject Research, etc.
  • Requests for directed reviews should be submitted in writing to the VPR/IO and RCQA outlining the reason(s) for the request.
  • Directed reviews may also result from an anonymous complaint reported directly to RCQA or via CaneWatch