Quality Assurance & Quality Improvement
QA/QI Program
Ensuring High Ethical Standards & research Integrity
The Quality Assurance / Quality Improvement (QA/QI) Program assists the University of South 91社区 (USF), its affiliated partners, and our researchers in performing human subject research of the highest ethical standards and promoting confidence in the integrity of human subject research at our institution. This program conducts random and for cause evaluations of human subject research activities under the oversight of the USF Human Research Protection Program (HRPP) to ensure adherence with federal regulations, state and local laws, and institutional policies and procedures. In addition, the QA/QI Program provides training and education to researchers and their study teams and offers them tools to facilitate the conduct of their research.
researcher Tools & Templates
The QA/QI Program provides to aid researchers in adding quality, clarity and depth to their research documentation. Additional resources can be found in USF Box.
Examples of the Tools/Templates listed below that are available:
- Self-Assessment Checklist
- Consent process documentation templates
- Regulatory file table of contents
- Delegation log
- Training log
- Drug/Device logs
- Pre-screening and enrollment logs
- Adverse & Serious adverse event logs
- Deviation and non-compliance logs
- Subject compensation log
- Subject withdraw documentation
Researcher Services
The QA/QI Program encourages all research to follow . Some research is required to follow these guidelines by regulatory authorities. The tools and templates available may help study teams maintain compliance with these expectations. Contact us if you have questions: QA-QI@usf.edu. We offer a variety of services to assist our researchers and their research teams:
- External Audit Preparation Assistance (FDA, NIH, or other external agency)
- Research Records Education & Training (USF and USF-affiliate researchers and their staff) regarding best practices for
maintaining human subject research records for all IRB-approved studies under the
oversight of the USF Human Research Protection Program
- Corrective and Preventative Action (CAPA) Plan Development in order to facilitate investigator responses to identified noncompliance
- On-site Consultations to assist in setting up new studies or monitoring ongoing studies
- Annotated Study Binders to facilitate documentation of human subject research activities
- External Audit Response - (USF and USF-affiliate researcher) Assistance including regulatory guidance and development
of corrective and preventative action plans to prevent future non-compliance (e.g.
response to FDA-483 or FDA Warning Letter)
- Study Team Tools to facilitate documentation of research activities (self-assessment checklists, study logs, etc.)
Audits & monitoring
The QA/QI Program audits and/or monitors human research activities at USF and its affiliate partners for adherence to federal regulations, state laws, and institutional policies and procedures governing human research protections. Our activities focus on the following key areas:
- IRB Approval Continuity
- Informed Consent Process
- Adherence to the IRB-approved Protocol
- Unanticipated Problem & Adverse Event Reporting
- Regulatory Records Maintenance
- Research Record Storage
Clinical Trials Registration & Compliance
is a Protocol Registry and Results System (PRS) database of publicly and privately supported research studies conducted in the United States and around the world. Sponsors or investigators of certain clinical trials are required by U.S. law to register their trials and submit results to ClinicalTrials.gov. Please refer to the for a basic overview.
Contact the QA/QI Program for any questions or to obtain access to register a new trial: QA-QI@usf.edu.