We provide expertise and guidance on completion of a variety of research forms and regulatory documents required when implementing a clinical study.

Regulatory consultations are available to guide and support you as you design protocols, navigate through the approval process, and conduct your research.

Services include:

• Guidance with protocol development
• Quality assurance / study monitoring services
• IRB application guidance and review
• Guidance responding to IRB contingencies
• Consent form development
• Consent process guidance
• Regulatory document guidance
• Guidance with study implementation
• Guidance with ClinicalTrials.gov registration and results posting requirements

Remote Consent

Due to the presence of COVID-19, many researchers have been hard at work to pivot studies from in-person to remote activities. NC TraCS, in collaboration with the Office for Human Research Ethics, School of Medicine Clinical Research Support Office, and UNC ITS has developed a document outlining best practices and options on conducting the informed consent process remotely.

Quality assurance / study monitoring services

ClinicalTrials.gov