To identify barriers to the conduct of research and to ensure that the clinical and translational research enterprise meets current good clinical practice, Internal Review Board, and other regulatory requirements, Quality Assurance and Quality Improvement (QA/QI) facilitators coordinate and implement the following quality improvement activities:
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Routine On-site Review - assists an investigator in implementing procedures and maintaining research records in compliance with regulations and institutional policies or prepares a study team for an audit by a sponsor or federal agency.
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Investigator Self-assessment Review – provides a means for an investigator to monitor human subject protections in an ongoing study. A participant survey allows investigators to invite enrolled subjects to participate in this formative assessment. See the Related Links for Principal Investigator Self-Assessment Forms and a Research Participant Survey Template.
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Administrative Assessment Review - measures program quality at the unit level to determine target areas for staff development.
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Overview Review - assesses the quality of educational outreach and information and support provided to regional CCTS sites and community partners, using quality assurance tools from the federal Office of Human Research Protections and Food and Drug Administration.
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To request a QA/QI review, or to request training in how to conduct a QA/QI review, please use the Contact Information.