Quality Assurance Auditing
Types of Audits
The Office of Research Compliance & Quality Assurance (RCQA) conducts good clinical practice and social behavioral audits. Depending on the source of the audit request, we differentiate between directed and routine audits:
- Directed audits are requested by an internal or external committee or individual. Requests may be submitted by the Institutional Review Board (IRB), the Data and Safety Monitoring Committee or the Vice Provost for Research.
- Audits are requested by regulatory agencies such as the Office for Human Research Protections (OHRP).
- Routine audits are selected by pre-determined criteria based on assessment of regulatory risk, including the funding source, the number or type of studies conducted by an investigator, studies involving vulnerable populations, investigators holding Investigational New Drug Applications (IND), and investigators not using the research pharmacy, etc.
The regulations we use in the audit process include:
- Federal regulations governing human subject research
- Code of Federal Regulations 45CFR and 21CFR
- International Conference on Harmonization – Good Clinical Practice (ICH-GCP)
- State regulations
- University policies and procedures including the External Audits for Research Policy (PDF), the FDA Audit Guidelines (PDF), and the Principal Investigator (PI) Audit Response Form (DOCX)
- Research website’s Standard Operating Procedures (SOP)