Research Compliance & Quality Assurance (RCQA)
To reinforce the Compliance Program at the University of Miami by promoting and sustaining the highest quality clinical research, with the goal of protecting human subjects and maintaining research integrity. To reach this goal our office promotes continuous quality improvement by offering audits of clinical research, clinical trial disclosure support, CAPA management, CAPA follow-up and educational seminars.
The offices support and help clinical and translational investigators to comply with national and international regulations and guidelines from the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), International Conference on Harmonisation-Good Clinical Practice (ICH-GCP), European Medicines Agency (EMA), as well as state laws and local policies and procedures.
RCQA provides the following services:
- Voluntary assessments
- Preparation of Principal Investigators (PIs) and study teams for external federal audits
- Assistance for PIs and study teams during external federal audits
- Assistance with responses to federal agencies (Form FDA 483, EMA audit reports, NIH audit reports, etc.)
- Corrective And Preventive Action (CAPA) system
- Clinical Trial Disclosure Compliance System
- Research related education and training
University of Miami is registered with ClinicalTrials.gov. For assistance with protocol registration and results reporting, contact the Protocol Registration Administrator (PRS) Yolanda Davis email@example.com and include CT.gov in the subject line.
Meet the team:
Phone: (305) 243-4538
Phone: (305) 243-4306
Phone: (305) 243-7797
Phone: (305) 243-4994
Phone: (305) 243-0135
Clinical Trials Disclosure Manager
Phone: (305) 243-0494
Patty Hitchcock Tate
Sr. Administrative Assistant
Phone: (305) 243-9740