Jefferson Office of Human Research Protection
Leadership
- Director, Jefferson Office of Human Research Protection
- Director, Clinical Research Unit
- Professor, SKMC Department of Pharmacology & Experimental Therapeutics
For Research Activities
- Senior Associate Provost, Research Integrity, Conduct & Compliance
- Professor, SKMC Department of Pathology & Genomic Medicine
Quality Assurance Program
The Quality Assurance Program is a separate group within the JOHRP.
The Quality Assurance Program 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 QA Program performs routine and for-cause study audits for the Jefferson Enterprise.
- Study teams may request a pre-audit in preparation for a regulatory inspection
- OHR Policy and Form Maintenance
- The QA Program is happy to accept questions and suggestions on the JOHRP policies and forms.
- Compliance Support
- The QA Program is available for questions on the policies and regulations.
- Consent Observation and Feedback
- If you would like feedback on your consenting technique, the QA Program can observe you consenting a subject or we can do a mock consent.
- Audits of JOHRP/IRB
- The QA Program conducts regular audits of JOHRP/IRB's study files and processes.
Here is a list of Essential Documents typically found in a research study file.
For any questions related to the above, please contact the Quality Assurance Program. For IRB submissions and all other queries, contact the appropriate person in JOHRP.