About Quality Assurance

Quality Reviews

To facilitate continuous quality improvement, RQA performs internal Quality Reviews of human subject research conducted throughout the University of Miami. We conduct several types of Quality Reviews, as outlined below, which span both interventional (biomedical & social-behavioral) and non-interventional (observational) studies of human subjects. These reviews are intended to assess adherence to the following:

  • Applicable Federal & State regulations & international guidelines
  • University policies & procedures
  • Study protocol requirements

Through these reviews, we aim to provide Investigators and their study teams with objective feedback, guidance, and recommendations to improve research practices.

Our Approach

Referencing only applicable and objective standards (i.e. regulations, policies) our team of auditors conducts Quality Reviews in a friendly, collegial, and collaborative manner as a service to the University’s research community.

RQA conducts four (4) types of internal reviews illustrated below:

Accordion Group

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  • 1. Investigator-Requested Reviews:

    Investigators may request any of the following reviews according to their specific needs:

    A. Audit Preparation Assessment: This type of review will assess the study team's inspection readiness and help them prepare for an upcoming FDA Inspection or sponsor audit.
    B. Study Start-Up Review: This is a review of the study teams' processes and forms (e.g., forms for sample collection, chain of custody, sample processing, etc.) prior to enrolling the first subject. Especially recommended for inter-departmental/translational studies, for new investigators/research teams, as well as studies that are not monitored.
    C. Study Review: This is a review of studies already in progress with at least one subject enrolled. These reviews are intended for studies that are not monitored.
    D. Mock FDA Audit: For this type of review, RQA will simulate an FDA inspection. This training exercise includes a review of study records as well as coaching study teams on how to effectively interact and communicate with FDA investigators.

    Following each Investigator-Requested review, a summary report with recommendations for improvement will be issued to the Investigator and their study team. A Corrective and Prevention Action (CAPA) Plan for these Investigator-Requested reviews will not be required.

    Investigator-Requested reviews will be scheduled on a first-come first-serve basis, and as available resources allow. Note that Directed Quality Reviews have priority.

  • 2. Routine Quality Reviews

    Studies are selected by RQA using a risk-based approach, and with the intent of reaching and connecting with researchers, departments and units across all disciplines conducting human subject research. See 🔗 criteria for risk-based study selections. Refer to our FAQs to learn more about the Quality Review process.

  • 3. Directed Quality Reviews

    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 (VPR), Executive Dean for Research (EDR), etc., or they may also result from an anonymous complaint reported directly to RQA or via the University Hotline.

  • 4. Focused Quality Reviews

    These reviews, typically limited to a particular aspect of the research (e.g. the informed consent process, dispensation of investigational product, etc.), may be Routine or Directed.

Assistance With Federal or Other Governmental Audits

RQA provides centralized support for Principal Investigators (PIs) and research teams before, during, and after audits or inspections by federal agencies (FDA, OHRP, NIH, EMA) and other governmental bodies.

🔗The University of Miami Policy: Hosting External Governmental Audits of Clinical Research (policystat.com) describes the process instituded to facilitate external audits.

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NOTIFICATION REQUIREMENT

  • PI's and research teams must notify RQA immediately upon receiving an audit notification.

RQA RESPONSIBILITIES

  • Leadership Notification: Inform University leadership of the announced audit/inspection.
  • Audit Hosting:  Provide support and resources for external inspectors during on-site visits.
  • Preparation & Guidance: 
    • Advise PIs and study teams on audit preparation and interaction with inspectors.
    • Assess site readiness and summarize deficiencies if time permits
  • Logistics:
    • Provide a secure, dedicated room for the audit.
    • Accompany PIs and teams during initial meetings, interviews, and debriefings.
  • Issue Management: Update University officials on potential issues during or after the audit.
  • CAPA Support: Guide PIs and teams in developing Corrective and Preventive Action (CAPA) Plans.
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