Human Research Protection Program

Quality Improvement Program

About Quality Improvement

The Quality Improvement Program involves both quality assurance and quality improvement.The primary focus of the Quality Improvement staff is the conduct of research. The Quality Improvement staff works with the investigator, members of the research team and MCW/FH IRBs to conduct research studies in a safe, compliant and ethical fashion.

Our Objectives

• 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/FH IRBs and other MCW/FH parties regarding the conduct of research.
• Liaise between the investigator and the research team members, and the Office of Research Staff to ensure accurate information and education is clearly communicated and implemented.

Services

• Conduct for-cause audits authorized by the IRB/Assistant Dean of Clinical Research (David Clark, PhD).
• Conduct routine reviews, includes review of study documentation and may include observation of study activities with provision of feedback regarding the good clinical practices associated with the conduct of the study and areas for improvement.
• Provide updated information concerning compliance in the conduct of research to MCW/FH IRBs, investigators, and research team members, in regard to MCW policies, federal regulations, and good clinical practice.
• Provide information regarding educational offerings, such as IRB Open Houses and Research Professionals Meeting.
• 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.
• Provide assistance in preparation for an external audit by a sponsor or federal agency.
• Provide checklists and assist with the creation and organization of regulatory files and subject files.
• Provide information to research participants regarding their rights and responsibilities in a research study.
• Serve as the contact for problems or complaints from research subjects associated with their participation in a study.