Core 4: Regulatory Compliance

Core 4: Regulatory Compliance Abstract The Regulatory Compliance Core (RCC) serves to facilitate the advanced development of medical countermeasures for pathogens that require maximum containment. This includes studies aimed to evaluate efficacy by evaluation in animal models intended for submission via the US Food and Drug Administration (FDA) Animal Rule, or studies aimed to evaluate safety following the FDA Good Laboratory Practice (GLP) regulations. Together with studies that are performed under a Quality System agreed with a sponsor, these are considered “Well Documented Studies.” The RCC is comprised of a Nonclinical Studies unit, that is responsible for the conduct of studies, and an independent Quality Assurance Unit provides oversight of those studies to assure compliance with regulations. The specific aims of the RCC are to: 1. Develop and refine the processes required to carry out Well-Documented studies, respond to audits, and continually improve the program; 2. Monitor Well Documented studies for accuracy and integrity of any data generated in such studies; 3. Conduct relevant Well Documented compliance training for relevant personnel; 4. Develop policies and procedures pertaining to the Regulatory Compliance Core. The RCC is the fulcrum for all the stakeholders involved in the accomplishment of Well Documented Studies. Critical participants in studies include: Principal Investigators, Study Directors (SD), Study Point of Control (SPOC); Quality Assurance; Test Facility Management (TFM); Boston University Leadership; Sponsors; Laboratorians; Veterinary staff; Facility maintenance; and Biological safety. Coordination of a Well Documented study relies on tight integration and begins with early and frequent communication. The PI of a study, the SD for GLP, or SPOC for Animal Rule, and members of the Quality Assurance Unit start discussing a project during the proposal development stage. This assures that feasibility, including consideration of the Master Schedule, are considered and risks are mitigated. In particular, it is preferred that a sponsor agrees to a Quality Plan for a study that does not have a GLP-requirement; the SD/SPOC, PI, and Quality Assurance Unit work closely to develop these plans. As the protocol is developed further other stakeholders are incorporated into the discussions. All parties are involved in the execution of a study, and RCC assures a lessons-learned discussion occurs following study completion.