History

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Research Quality Assurance (RQA) 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)
 

 


 

 

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