QA/QI
Researcher Tools
The Quality Assurance / Quality Improvement (QA/QI) Program has several templates available to aid researchers in adding quality, clarity and depth to their research documentation.
Examples of the Tools/Templates listed below are available in USF Box:
- 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 event and Serious adverse event logs
- Deviation and non-compliance logs
- Subject compensation log
- Subject withdraw documentation
Something to keep in mind:
The QA/QI Program encourages all research to follow International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 Guidelines (PDF). 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.