HRPP Quality Improvement
The HRPP Quality Improvement/Quality Assurance staff work with investigators, research teams, and MCW IRBs to ensure safe, compliant and ethical conduct of human subject research.
- Provide accurate, complete, ongoing information regarding the safe, compliant and ethical conduct of research.
- Identify and promote standards of good clinical practices in the conduct of research.
- Provide feedback to investigators, research team members, MCW IRBs regarding the conduct of research.
- Liaise between the investigator and the research team members, and the IRB Staff to ensure accurate information is clearly communicated and, if applicable, corrective actions implemented.
- Conduct routine reviews of IRB approved research projects.
- Observe research consent process.
- Conduct for-cause audits authorized by the HRPP Director.
- Provide updated information to investigators, and research team members reflecting MCW policies, federal regulations, and good clinical practice regarding the conduct of research.
- Assist in the development of quality assurance activities for department use.
- Provide guidance and consultation regarding quality improvement in the conduct of ongoing or new research.
- Assist in preparation for an external audit by a sponsor or federal agency.
- Provide checklists for creation and organization of regulatory and subject files.
- Serve as the Research Subject Advocate for received complaints from research subjects.
Audit Prep, Participation & Follow upHuman subject research projects may be audited as a surveillance activity or for-cause by Sponsors, Regulatory Authorities or by the Institution...
Corrective Action PlanRoutine Review results may require implementation of a corrective action plan.
Request a For Cause AuditAnyone can request a For Cause Audit, which must be authorized by the HRPP Director.
Routine ReviewsRoutine Reviews are a mechanism to provide feedback regarding the conduct of research.
Routine Review ScheduleScheduled timeframes for onsite Routine Reviews of IRB approved projects by department.
For questions about consent observations, routine reviews, sponsor audits, regulatory audits, or to schedule a study start up visit.