The CCTS recognizes the importance of ensuring quality data and human subject
protection in clinical research.
We partner with our investigators to assist in achieving this by providing ongoing support,
education, study management tools and best practice recommendations.
What qualifies a study for QA/QI review?
When you accept CCTS support or services on your investigator initiated, human clinical protocol, it may fall under the CCTS Quality Improvement program.
Studies that fall under the purview of the CCTS QA/QI program include investigator initiated, human clinical studies with the following:
- Studies with funding from the CCTS pilot, KL2, or TL1 programs
- Studies being reviewed by the CCTS Data Safety Monitoring Board (DSMB)
- Studies utilizing the following CCTS services
- Clinical Research Unit (CRU)
- Regulatory Knowledge and Support
- Functional Assessment and Body Composition (FAABC)
- Biomarker Analysis Lab (BAL) if your study is a prospective study
How do I get started?
It’s easy! If your study qualifies for QA/QI review, contact the Quality Improvement Team after enrolling your first participant and they will schedule your visit.
What will be reviewed during your visit?
The visit will be focused on educational opportunities related to Good Clinical
Practice (GCP). Your participant and regulatory study documentation will be
reviewed. There is nothing to prepare for, however you will want to have your study
documentation readily available for the reviewer.
What are the benefits of a QA/QI review?
- Protecting Human Subjects
Our #1 priority is our Subjects and ensuring they are participating in quality research that respects their rights as research subjects.
- Quality Research
The QA/QI program offers an opportunity for you to receive feedback on your protocol and address any areas of weakness before they become an issue. Our QA/QI specialist has many years of experience and can help you work through any potential problems that may be identified.
The CCTS partners with other research entities including Markey Cancer Center (MCC) and Office of Research Integrity (ORI) on campus to identify areas that might benefit from additional education. We design our educational opportunities based on this feedback received through our QA/QI program and from our investigators. You are helping to shape the future of research at UK with your participation.
Other things you should know
- QA/QI is an opportunity for you and your study team to receive input on ways to ensure your study is successful.
- We will work with you to address any areas that may be identified as needing improvement.
- Education and continuous improvement initiatives are based on outcomes from the QA/QI program.
- Adverse Event Log - Instructions - Jan 2022
- Adverse Event Log - Template
- Consenting Checklist - Instructions (pdf)
- Consenting Checklist - Template (docx)
- Consenting Note - Instructions (pdf)
- Consenting Note - Template (docx)
- CV, Medical License, HSP and GCP Log - Instructions (pdf)
- CV, Medical License, HSP and GCP Log - Template (xls)
- Device Accountability Log - Instructions (pdf)
- Device Accountability Log - Template (xls)
- Drug Accountability Log - Instructions (pdf)
- Drug Accountability Log - Template (xls)
- IRB Submission log - Instructions (pdf)
- Eligibility Checklist - Template (docx)
- Eligibility Checklist - Instructions (pdf)
- IRB Submission Log Instructions
- IRB Submission log - Template (xls)
- Monitoring Visit Log - Instructions (pdf)
- Monitoring Visit Log - Template (docx)
- Note to File - Instructions (pdf)
- Note to File - Template (docx)
- Principal Investigator 101
- Screening and Enrollment Log - Instructions (pdf)
- Screening and Enrollment Log - Template (docx)
- Study Signature and Delegation Log - Instructions (pdf)
- Study Signature and Delegation Log - Template (xls)
- Training Log - Instructions (pdf)
- Training Log - Template 1 (docx)
- Training Log - Template 2 (xls)
- Training Log - Template 3 (xls)
- QA/QI Self Assessment Tool
William Stoops, PhD
- Director, Regulatory Knowledge and Support Core
- (859) 257-5388
Ada Sue Selwitz, MS
- Co-Director, Regulatory Knowledge and Support Core
- (859) 257-9454
Reva Bruns, CCRP, CQE, CQA, CMQ/OE
- Clinical Research Associate, QA/QI Coordinator
- (859) 323-9446