The PTraC Regulatory Core aims to help investigators and their study team in the Division with translational and clinical research projects in dealing with the complexities of research regulatory compliance in order to minimize their efforts and facilitate success throughout the lifetime of their research projects. The consultations and activities offered aimed to help ensure compliance with FDA, federal, State, local and industry guidelines and regulations.

Types of services provided by the RC include:

• Offering new research project consultation; assistance in translating a research idea into a complete research proposal.
• Providing assistance with IRB initial and ongoing submissions, and preparing regulatory review submission documents such as informed consent, fiscal review forms, etc.
• Providing assistance in navigating through multiple internal and external scientific and regulatory review and approval entities in moving the research process forward.
• Review of all new protocol applications to assure compliance with IRB, NIH, and other regulatory agencies鈥�

Please contact Jake Atkins at jake.atkins@cuanschutz.edu if you need further assistance.鈥�