Quality Assurance

The Quality Assurance (QA) division of the Office of Research Compliance performs a variety of audits and reviews to ensure that research is conducted in adherence to applicable laws, regulations, institutional policies and best practices.

Research Compliance review areas include:

  • Good Clinical Practice (GCP), informed consent and other areas for human research protection program compliance
  • HIPAA privacy and security reviews of studies involving the use of Protected Health Information (PHI)
  • Investigational Product (e.g. drug, device biologic) & controlled substances accountability
  • IACUC post-approval monitoring
  • Biosafety, biosecurity and laboratory safety
  • Conflict of interest and management plan compliance
  • Regulatory committee (e.g. IRB, IACUC, RDRC, IBC, etc.) compliance
  • Policy compliance
  • Clinical Research billing
  • Grant to protocol congruence
  • Other areas as needed

The QA Division also provides a variety of services including:

  • Site initiation visits focusing on regulatory requirements
  • Consultations during the course of your study
  • Pre-reviews focused on regulatory documentation (e.g.  regulatory approvals, regulatory documentation, consent forms) prior to external audits/reviews

Contact the ORC to inquire about our services.