Core 4: Regulatory Compliance

核心 4：监管合规性

• 批准号: 10447707
• 负责人: RONALD B CORLEY
• 金额: $ 37.25万
• 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/10447707
• 关键词: Advanced Development; Animal Model; Biological; Boston; Communication; Containment; Control Animal; Data; Development; Emerging Communicable Diseases; Human Resources; Infectious Diseases Research; Leadership; Maintenance; Monitor; Participant; Policies; Principal Investigator; Procedures; Process; Protocols documentation; Regulation; Risk; 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

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：法规合规性 抽象的 监管合规核心（RCC）有助于促进医学的高级发展 病原体需要最大遏制的病原体的对策。这包括旨在评估的研究 旨在通过美国食品药品管理局提交的动物模型评估效率 （FDA）动物规则，或旨在评估FDA良好实验室实践（GLP）的安全性研究 法规。以及在与赞助商一致的质量系统下进行的研究，这些是 被认为是“有据可查的研究”。 RCC由非临床研究单元组成，即 负责进行研究的负责，一个独立的质量保证单位提供了对这些的监督 确保符合法规的研究。 RCC的具体目的是：1。开发和完善 进行有据可查的研究所需的过程，对审计做出响应并不断改进 程序; 2.监视据记录的研究，以确保此类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据具有证明的合规性培训； 4。制定政策 和与监管合规性核心有关的程序。 RCC是所有利益相关者的支点 参与实现良好的研究。研究的关键参与者包括：校长 研究人员，研究主管（SD），控制点（SPOC）；质量保证；测试设施 管理（TFM）；波士顿大学领导层；赞助商；实验室人员；兽医；设施 维护;和生物安全。一项据可查的研究协调依赖于紧密整合和 从早期和经常沟通开始。研究的PI，GLP的SD或动物规则的SPOC， 质量保证部门的成员开始在提案开发阶段讨论一个项目。 这假定可行性（包括考虑主表）被考虑，风险是 缓解。特别是，赞助商同意没有一个没有的研究的质量计划 GLP征用； SD/SPOC，PI和质量保证单元紧密地制定了这些计划。作为 协议是进一步开发的其他利益相关者。所有各方都参与 在研究的执行中，RCC假设研究完成后进行了课程学习的讨论。