HRPP Quality Improvement
The HRPP Quality Improvement activities involve both quality assurance and quality improvement. The primary focus of the Quality Improvement staff is the conduct of research. The Quality Improvement staff work with the Investigator, members of the research team and MCW IRBs to conduct research projects in a safe, compliant and ethical fashion.
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 Director, Human Research Protections Program.
- 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 regarding creation and organization of regulatory files and subject files.
- Serve as the Research Subject Advocate for received complaints from research subjects.
For any questions about consent observations, routine reviews, Sponsor audits, regulatory audits or to schedule a study start up visit.