Regulatory Core

The PTRC Regulatory Core aims to help investigators and their study team in the Division of PACCM 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. A major emphasis of the PTRC Regulatory Core is to enrich the capabilities of investigators and the study team, and provide them with insight and skills pertinent to regulatory aspects of clinical and translational research. The consultations and activities offered aimed to help ensure compliance with FDA, federal, State, local and industry guidelines and regulations.

Services

• Offering new research project consultation; assistance in translating a research idea into a complete research proposal.
• Providing assistance in grant writing, budget estimation and preparation, study development and design of clinical research protocols.
• 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.
• Supporting investigators with the navigation of and compliance with specific FDA-regulated processes, including research involving experimental drugs and devices, and development of IND/IDE application submissions and provides guidance and assistance throughout the life cycle of FDA-regulated studies.
• Offering regulatory education and training to investigators and their study team to increase knowledge about human subjects protection
• Assisting investigators in developing management plans for conflicts of interest
• Review of all new protocol applications to assure compliance with IRB, NIH, and other regulatory agencies

To utilize Regulatory Core services, submit a PTRC Service Support Request.