The mission of the Office of Clinical Trials (OCT) is to serve the Carolina research community by improving the quality of support by facilitating and streamlining the startup, conduct and administration of clinical trials.
In support of that mission, the OCT strives to:
- Standardize the processes for clinical trials to ensure consistency, efficiency, and compliance with Federal, State and University requirements;
- Provide educational opportunities to research faculty and staff;
- Facilitate regulatory knowledge and support to investigators and clinical research professionals to enhance compliance with federal and institutional requirements;
- Identify and/or support development of new clinical research opportunities in collaboration with our clinical research teams;
- Encourage interdisciplinary collaboration for clinical research and incorporate available resources throughout the University and UNC Health Care.
720 Martin Luther King, Jr. Blvd., CB 1651
Chapel Hill, NC 27599-1651
For clinical trials subject to the DHHS Final Rule and/or NIH Policy, UNC requires that the Principal Investigator ensure proper registration and results reporting consistent with the requirements of these authorities.
Network of Research Professionals
The NRP is a peer group that is open to all research personnel to help increase awareness and communication of best practices through a series of educational seminars, resources, mentoring and networking programs.
The mission of the North Carolina Translational & Clinical Sciences Institute (NC TraCS) is to accelerate clinical and translational research from health science to discovery, to dissemination, to patients, and communities.
NC TraCS provides full-service regulatory support and assistance in navigating FDA regulations for Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications.
- Good Clinical Practice Training
- Data and Safety Monitoring Resources
- Office of Clinical Trials Policies
- Clinical Trials Flowchart 🖺
- ACRP Certification 🡥
- SOCRA Certification 🡥
- i2b2 (De-identified Healthcare Data)
- Clinical Data Research Networks
- Research Electronic Data Capture
- Data and Safety Monitoring Board
- IND & IDE Application Support
- Protocol & IRB Guidance and Support
- Ethics Consults
- Network for Research Professionals
- NC TraCS brochure 🖺