Quality Review Process

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RQA reviews are intended to be a collaborative process between the research team and the RQA auditors. In order to ensure that communication between the two parties continues throughout the review process, meetings and debriefings are scheduled with the Principal Investigator and research team for every review conducted.

For details on the Quality Review process, please see link below:

Flowchart of the RQA Quality Review process (.pdf file download)

For an overview of the documents reviewed during a Quality Review, please see link below:

Categories Reviewed During an RQA Quality Review (.pdf file download)

Standards Used for Quality Reviews - Regulations, Guidelines and Policies

RQA reviews are conducted to assess the research teams' level of adherence to the following, as applicable

Federal regulations governing human subject research:
- 45 CFR 46
- 21 CFR 50, 54, 56, 312, 812
International Conference on Harmonization, Guidelines for Good Clinical Practice - ICH-GCP (R2)
State of Florida regulations
University of Miami policies and procedures governing human subject research
- Investigator Manual
- Standard Operating Procedures
- policy HSR-P-002: External Audits for Research
- policy for Clinical Research Participant Enrollment and Tracking
IRB-approved study protocol
Site-specific standard operating procedures

Quality Assurance

Coral Gables, FL 33124
305-243-4306 305-243-4306

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