A message to the research community on research compliance.
Dear UNC Research Community,
We are pleased to announce important updates to our clinical research compliance services. Effective immediately, the Clinical Research Compliance Office (CRCO) is the new, central point of contact for all Investigational New Drug (IND) and Investigational Device Exemption (IDE) compliance requirements from the Food and Drug Administration (FDA).
Key Points:
- Point of Contact:
- The Office of the Vice Chancellor for Research (OVCR) has worked with TraCS to transfer support for all matters related to IND and IDE compliance to the Clinical Research Compliance Office.
- For any questions or assistance regarding IND/IDE submissions to the FDA, please reach out to the Clinical Research Compliance Office at ClinResComp@unc.edu.
- The CRCO will provide support to UNC researchers in the preparation or review of:
- Initial IND or IDE applications
- Annual progress reports
- Responses to FDA inquiries
- Institutional Oversight:
- The CRCO is committed to ensuring appropriate institutional oversight of commitments made under investigator-sponsored INDs and IDEs.
- The CRCO will work closely with researchers to uphold compliance standards and facilitate successful interactions with the FDA.
- Resources:
- OVCR has temporarily contracted with Advarra to provide additional subject matter expertise and administrative support while the CRCO fills vacant positions.
- Please reach out to the CRCO who will coordinate with Advarra to ensure responsive timelines and accurate advice to ensure that investigators have the best support services available.
Please feel free to contact the CRCO for any further clarifications or assistance. We are dedicated to supporting your clinical research endeavors and maintaining the highest standards of compliance.
Thank you for your continued commitment to advancing scientific discovery and improving patient care.
Sincerely,
Quinton Johnson
AVC for Research Compliance
Office of the Vice Chancellor for Research