For Research Activities
Quality Improvement Group
The Quality Improvement Group is a separate group within the OHR.
The Quality Improvement Group has the same goal as you: to conduct clinical research to the highest standard and to protect the rights and welfare of research subjects. We perform audits of your studies as a way of making sure that these standards are being met. We will work with you to develop the best way of performing your responsibilities while following regulations and company policy. Our goal is to help you conduct your studies in the most efficient and compliant way possible.
Our responsibilities include:
- Study Audits
- The QI Group performs routine and for-cause study audits for the Jefferson Enterprise.
- Study teams may request a review of study documents (i.e., preparing for FDA inspection).
- OHR Policy and Form Maintenance
- The QI Group is happy to accept questions and suggestions on the OHR policies and forms.
- Compliance Support
- The QI Group is available for questions on the policies and regulations.
- Consent Observation and Feedback
- If you would like feedback on your consenting technique, the QI Group can observe you consenting a subject or we can do a mock consent.
- Audits of the OHR/IRB
- The QI Group conducts regular audits of the OHR/IRB's study files and processes.