Office of Clinical Trials
New requirement:
Any unit which proposes to purchase or implement any electronic system or solution for the support of clinical research must request (in advance) approval for the proposed solution.
The revised Common Rule (also referred to as the 2018 Requirements) 1 at 45 CFR 46.116 (h) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial.
Informed Consent Posting Instructions | HHS.gov
The Office of Clinical Trials provides compliance and regulatory support for clinical trials at UNC.
If you are interested in sponsoring a clinical trial at UNC, contact Ashwini Roy-Chaudhury at ashwini_roy-chaudhury@med.unc.edu or (919) 843-0832 and she can connect you with the appropriate offices at UNC.
The core purpose of the Office of Clinical Trials (OCT) is to ensure compliance with federal, state and institutional requirements.
- Supporting the Human Research Protection Program by conducting post IRB approval reviews of clinical studies through the Clinical Trials Quality Assurance (CTQA) program
- Ensure correct clinical trial billing of research subjects through the Research Billing Compliance Program
- Ensure compliance with the ClinicalTrials.gov registration results reporting
- Ensure compliance by reviewing the billing coverage analysis, fully executed agreement and IRB approved consent form for congruency and accuracy
- Coordinate the Scientific Review Committee and serve as a resource for protocol development for the research community
- Serving as the point of contact for questions or issues related to clinical trials
- Developing and implementing programs and initiatives to enhance the quality of clinical research and support regulatory compliance, through the implementation of the OnCore clinical trials management system enterprise wide
- Our office is available for education, consultation and guidance on the conduct of clinical trials