Compliance Monitoring and Quality Improvement
This policy describes the process by which UW-Madison will assess and improve its Human Research Protection Program (HRPP).
- UW-Madison monitors the Quality, Efficiency and Effectiveness of its HRPP.
- UW-Madison utilizes the following methods to evaluate its HRPP.
- Several units of the HRPP monitor and ensure individual research projects are being carried out in accordance with the approved study, applicable ethical principles, local, state, federal, national/international rules, regulations, guidance and standards, and University policies and procedures.
- The Data and Safety Monitoring Committee of the Carbone Cancer Center (CCC) ensures that clinical research conducted under the aegis of the CCC is compliant with federal, UW and CCC policies, procedures and requirements by performing: internal audits; quality assurance reviews, response reviews; protocol summary reports; and database monitoring.
- The Institute for Clinical and Translational Research (ICTR) Study Monitoring Service Program serves as the independent Study Monitor of Record for those investigators requiring or desiring such oversight and conducts directed or for-cause reviews as requested by the ICTR Data Monitoring Committee, Health Sciences IRBs or other appropriate entities/agencies.
- The FDA Regulated Research Oversight Program conducts routine reviews of studies conducted under a faculty-held Investigational New Drug (IND) or Investigational Device Exemption (IDE) application with the FDA and may conduct directed or for-cause reviews as requested by appropriate entities/agencies.
- The Office of Research Compliance Post-Approval Monitoring (PAM) Program conducts directed and routine reviews across campus for studies that are not subject to review by one of the above HRPP units.
- The PAM program also assists the above HRPP units with their compliance efforts when requested.
- IRB function is monitored through a variety of mechanisms, including regular review of performance metrics, assessment of compliance with applicable policies and regulations, and other quality assurance efforts. IRB monitoring is performed by the Office Research Compliance (ORC), the IRB offices and the campus quality committees (e.g. QCOC, QCOAC).
- Several units of the HRPP, including the University of Wisconsin Hospital and Clinics (UWHC) and Clinical Research Unit (CRU), monitor outreach to study participants and the broader community.
- UW-Madison regularly evaluates the quality, efficiency and effectiveness of the HRPP, including outreach, educational activities, research project compliance and IRB review processes.
- HRPP assessments are accomplished through a cross-campus two committee structure that facilitates the centralized tracking and review of ongoing compliance, outreach, and educational activities along with process improvement initiatives.
- The Quality and Compliance Operations Committee (QCOC) includes major cross campus HRPP constituents involved with day-to-day compliance, outreach, and education activities.
- The QCOC meets approximately monthly to identify emerging compliance, outreach, and education issues and produce the Quality, Efficiency, and Effectiveness (QEE) Report for the HRPP at least yearly.
- The QEE Report recommends process improvements along with summarizing, aggregating and reflecting the above ongoing compliance and outreach activities.
- The Quality and Compliance Oversight and Advisory Committee (QCOAC) is chaired by the Institutional Official for the protection of human subjects and include those in leadership positions across the campus-wide HRPP.
- The QCOAC reviews the QEE Reports that are produced by the QCOC to identify institutional priorities, deficiencies, improvements, and determine appropriate resource allocation.
Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School
Adoption Date: November 3, 2011
Revised By: Cross-Campus HRPP Committee
Revision Date: August 28, 2015
Revision Date: April 7, 2016
Revision Date: January 3, 2019
Revision Date: May 3, 2019
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