History

um logo with open book

The Office or Research Compliance and Quality Assurance (RCQA) was created in 1999. The timeline below depicts the evolution of our office:

  • 1999: Creation of the Office of Research Compliance (ORC)
    • Audits of human subject research and animal studies
  • 2005: Our office was renamed to Research Compliance Assessment (RCA)
    • Audits for human subject research and some workshops were offered
  • 2008: Our office was renamed to Office of Research Compliance Assessment (ORCA)
    • Audits of human subject research
    • Consultation and guidance on research-related matters
    • Implementation of some basic GCP classes
  • 2010: Comprehensive educational classes (GCP) were created and implemented
    • Implementation of assistance to Investigators and research teams prior to, during and after federal audits
  • 2011: Our office was renamed to Regulatory Support and Quality Assurance (RSQA)
    • The monitoring group for the Medical School (today’s CRORS office) was implemented
  • 2013: Our office was renamed to Research Compliance and Quality Assurance (RCQA)
    • The monitoring group was separated from RCQA and became CRORS
    • The basic GCP training classes were transferred to CRORS
    • RCQA started developing research compliance educational classes
    • Implementation of the Clinical Trial Disclosure (CTD) Program
    • Implementation of the Corrective and Preventive Action (CAPA) Program
  • 2017:  Major changes in the QA/Auditing Program were implemented (issuance of Draft Report, changes in terminology, etc.)
  • 2018: Current RCQA services:
    • Quality Reviews (The term “audit” was replaced with “Quality Reviews”)
    • Clinical Trial Disclosure
    • Corrective and Preventive Actions System
    • Preparation for and Assistance to Investigators and teams before, during and after a federal audit
    • Research Compliance-related education (17 different training classes)
 

As you can see, our office and our team are constantly evolving. If you have ideas or would like to provide feedback, please let us know by either calling 305-243-4215 or email me at jstamates@med.miami.edu.

Johanna Stamates