An Educational Program to Enhance Data Quality and Integrity for Regulated Studies Supporting the Advancement of Medical Countermeasures for High Consequence Pathogens

项目摘要 为了保护全球健康和国家安全，针对高后果的医学对策（MCM） 病原体必须迅速发展。非临床研究和临床研究的计划和实施 这些微胶囊的研究试验通常在最大限度的封闭实验室或屏障护理中进行 环境.这些环境带来了独特的挑战，需要复杂的解决方案来确保数据 质量和完整性，以便可以做出监管决定，在监管批准中推进MCM 通路因此，一项教育计划旨在提高受监管研究的数据质量和完整性， 针对高后果病原体的医学对策的进展是由 UTMB与FDA反恐和新兴威胁办公室合作， 通过课程评价衡量的成果。教育计划中提供的每门课程都是 为相应的目标受众（包括医生）提供继续教育（CE）单位的认证， 护士、兽医和质量保证专业人员。 拟议的研究是一个强大的，协作教育计划的延续，使用基于问题的 学习技术，旨在使科学，医学，监管社区一起教育每个 此外，我们还将与其他国家一道，就与这些问题有关的挑战进行磋商，并确定可接受的解决办法。总纲 包括一个课程，以解决根据FDA动物规则和临床研究进行的非临床研究 审判良好实验室规范和良好临床实践的在线配套课程包括在 教育课程。在目标1中，我们将进行系统的教育计划审查，并形成一个 DEI咨询小组。在目标2中，我们将不断修改和更新非临床课程的交付 “在最大限度的封闭实验室中实现数据质量和完整性。在目标3中，我们将继续 修改和更新临床课程“在涉及以下内容的临床试验中实现数据质量和完整性”的交付 高后果病原体。”目标4涉及课程认证，计划可持续性，扩展到 一个健康的原则，和资源共享。 这个独特的教育计划的总体目标是提供一个学习环境，促进 想法的协作，为临床研究的开展提供工具，增强临床的相互理解， 科学和监管的复杂性，并促进数据质量和完整性，从这些受监管的 问题研究其结果将是一个更好的准备，临床，科学和监管专家的凝聚力社区 共同参与并致力于研究、开发和监管评估及批准 针对高后果病原体的医疗对策。

Project Summary To protect global health and our nation’s security, medical countermeasures (MCMs) for high consequence pathogens must be developed expeditiously. The planning and conduct of nonclinical studies and clinical research trials for these MCMs are often performed in maximum containment laboratories or barrier nursing environments. These environments present unique challenges and require complex solutions to assure the data quality and integrity such that a regulatory decision can be made to advance the MCM in the regulatory approval pathway. As such, an educational program to enhance data quality and integrity for regulated studies supporting the advancement of medical countermeasures for high consequence pathogens was developed in 2013 by the UTMB in collaboration with the FDA Office of Counterterrorism and Emerging Threats with consistent successful outcomes as measured through course evaluations. Each course offered in the educational program is credentialled for Continuing Education (CE) units for the corresponding target audience, to include physicians, nurses, veterinarians, and quality assurance professionals. The proposed research is a continuation of the robust, collaborative educational program using problem-based learning techniques designed to bring the scientific, medical, regulatory community together to educate each other on the challenges related to these issues and to identify solutions that are acceptable. The overall program consists of a course to address nonclinical studies conducted under the FDA Animal Rule and clinical research trials. Online companion courses in Good Laboratory Practice and Good Clinical Practice are included in the educational program curriculum. In Aim 1 we will conduct a systematic educational program review and form a DEI Advisory Panel. In Aim 2 we will continuously modify and update delivery of the Nonclinical Course “Achieving Data Quality and Integrity in Maximum Containment Laboratories.” In Aim 3 we will continuously modify and update delivery of the Clinical Course “Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens.” Aim 4 addresses course credentialing, program sustainability, expansion into One Health principles, and resource sharing. The overall goal of this unique educational program is to provide a learning environment that promotes collaboration of ideas, provides tools for clinical study conduct, enhances mutual understanding of clinical, scientific, and regulatory complexities, and promotes the data quality and integrity derived from these regulated studies. The outcome will be a better prepared, cohesive community of clinical, scientific, and regulatory experts mutually engaged in, and committed to, the research, development, and regulatory evaluation and approval of medical countermeasures for high consequence pathogens.