Human Research Protection Program

EmailEmail    |   Bookmark Page Bookmark  |   RSS Feeds RSS  |   Print Page Print  

Quality Improvement Program

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.

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.

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.
  • Observe research consent process and provide training and/or feedback to study team members.
  • 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.
  • Serve as the contact for problems or complaints from research subjects associated with their participation in a study.

Contact Information

Contact us to request help preparing for an audit, consultation, or to set up a review!

Roxanne M. Pritchard, RN, BSN, CIP
Manager Quality Improvement
Phone: (414) 955-8844
Fax: (414) 955-6565
rpritcha@mcw.edu

Gary L. Dennison, CIP
QI Specialist
Phone: (414) 955-8447
Fax: (414) 955-6565
gdennison@mcw.edu

Faye Overly, CIP
QI Specialist
Phone: (414) 955-4687
Fax: (414) 955-6565
foverly@mcw.edu


 

webmaster@mcw.edu
© 2014 Medical College of Wisconsin
Page Updated 06/20/2014