Core 4: Regulatory Compliance

核心 4：监管合规性

• 批准号: 10663835
• 负责人: RONALD B CORLEY
• 金额: $ 34.25万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10663835
• 关键词: Advanced Development; Agreement; Animal Model; Biological; Boston; Communication; Containment; Control Animal; Data; Development; Emerging Communicable Diseases; Evaluation; Human Resources; Infectious Diseases Research; Leadership; Learning; Maintenance; Monitor; Participant; Policies; Principal Investigator; Procedures; Process; Protocols documentation; Regulation; Safety; Schedule; System; Testing; Training; United States Food and Drug Administration; Universities; Work; animal rule; efficacy evaluation; good laboratory practice; improved; medical countermeasure; member; operation; pathogen; programs; quality assurance; risk mitigation

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.

核心 4：监管合规性 抽象的 监管合规核心（RCC）旨在促进医疗领域的先进发展 针对需要最大限度遏制的病原体的对策。这包括旨在评估 通过在拟通过美国食品和药物管理局提交的动物模型中评估疗效 (FDA) 动物规则，或旨在评估遵循 FDA 良好实验室规范 (GLP) 的安全性的研究 法规。连同在与申办者商定的质量体系下进行的研究一起，这些是 被认为是“有据可查的研究”。 RCC 由非临床研究部门组成，即 负责研究的进行，并有一个独立的质量保证单位对这些研究进行监督 研究以确保遵守法规。 RCC 的具体目标是： 1. 开发和完善 进行有据可查的研究、响应审计和持续改进 程序; 2. 监控有据可查的研究，以确保此类研究中生成的任何数据的准确性和完整性 研究； 3、对相关人员进行相关的Well Documented合规培训； 4. 制定政策 以及与监管合规核心相关的程序。 RCC是所有利益相关者的支点 参与完成有据可查的研究。研究的关键参与者包括： 校长 研究者、研究主管 (SD)、研究控制点 (SPOC)；质量保证；测试设施 管理（TFM）；波士顿大学领导力；赞助商；实验室人员；兽医人员；设施 维护;和生物安全。有据可查的研究的协调依赖于紧密的集成和 从早期和频繁的沟通开始。研究的 PI、GLP 的 SD 或动物规则的 SPOC， 质量保证部门的成员在提案制定阶段开始讨论项目。 这确保了可行性（包括对总进度表的考虑）得到了考虑，并且风险也得到了考虑 减轻了。特别是，申办者最好同意一项研究的质量计划，该研究没有 GLP 要求； SD/SPOC、PI 和质量保证部门密切合作来制定这些计划。作为 协议进一步制定，其他利益相关者也被纳入讨论。各方都参与其中 在研究执行过程中，RCC 确保在研究完成后进行经验教训讨论。