Getting Started
The Office of Research Integrity and Regulatory Affairs supports the research investigator and the clinical research community at the University of Texas Medical Branch. The team offers guidance on regulatory standards and best practices, regulatory submissions, clinical trial management, risk-based monitoring for clinical studies, and compliance. We offer quality value-added support in all aspects of clinical research from preclinical requirements to first-in-human studies and beyond to post market assessments. Our goal is to partner with the UTMB community and to develop regulatory "best fit" strategy in sharing knowledge, tools, and education needed to navigate the complex regulatory pathways that accompany pre-clinical, clinical, and translational research in a regulated environment. We intend do this by providing support in the following areas:
- Regulatory Strategy Development
- Clinical Trial Registration and Guidance
- IND/IDE Regulatory Submissions and Guidance
- Monitoring and Clinical Research Best Practices
- FDA Meetings and Inspections
- Regulatory Affairs Resources