Regulatory Knowledge and Support
Current regulatory requirements have reached a level of complexity that can prolong study start-up time, impede study conduct and disincentivize participation in clinical and translational research for those inexperienced or unfamiliar with the regulatory environment. Few academic investigators have an understanding of the intricacies involved in comprehensive regulatory management. Academic health care centers, in attempting to manage this complexity, have established programs that focus more on compliance than support. In the absence of centralized support services, bewildered investigators spend needless time attempting to find help or trying to decipher the regulations on their own. Our experts address issues related to research start-up and compliance that contribute to elongated study start-up times.
The Regulatory Knowledge and Support resource will facilitate the conduct of translational and clinical research from the regulatory perspective, improving compliance and efficiency. It will also provide a structure for the evaluation of existing programs for regulatory management and the development of innovative new programs. The objective of our Regulatory Knowledge and Support experts is to provide a centralized, researcher-focused, single point of contact for efficient regulatory start-up and CT management. To accomplish this, we provide: research education and compliance training, as well as regulatory support and quality monitoring for project-specific standard operating procedures, Data Safety Monitoring Boards, Investigational New Drug applications, and Investigational Device Exceptions. We collaborate with UTMB’s unique Institutional Office of Regulated Nonclinical Studies to ensure proper study design and documentation that leads to a smooth transition from animal model GLP studies to the IND filing that enables human studies.