Administrative Coordinating Center

行政核心还将对DTMI-CTHD项目和核心提供专门的监管监督。虽然这些服务是透过数码影像管理中心提供的，但主要是以教育和谘询为基础。由于项目2将需要提交IND，我们已将监管人员纳入管理核心。DTMI的监管事务(RA)小组提供 全面支持杜克大学赞助商-持有有效IND、IDE和/或生物许可证申请(BLAS)的调查人员。RA工作人员与研究人员合作，确定特定研究项目何时需要提交监管文件以及需要提交哪种类型的文件，然后对提交文件进行汇编和归档。发起人-调查人员在整个过程的每个步骤中都得到指导，并在必要时在制定方案、知情同意和监测计划方面得到协助。在最初提交文件后，RA工作人员协助主办方调查员履行维护IND/IDE的监管责任，包括定期安全更新、年度报告、向IRB提交的报告、修正案和任何其他报告要求。RA小组维护着一个中央数据库，其中包含杜克大学调查人员提交的所有监管文件。全 赞助商-IRB要求调查人员向RA小组登记他们的IND/LDE。这一政策是由IRB在其临床方案的初始或年度审查期间执行的。所有研究人员发起的研究必须提供IND或IDE已在RA小组注册的文件。该数据库包括IND或IDE的生效日期，使该小组能够将要求通知调查人员 在其IND或IDE提交周年纪念日提交年度报告。调查人员则被要求提供年度报告的确认书。该数据库还允许RA小组向调查人员通报FDA法规和指南的重要变化和更新。该数据库用于跟踪按时向FDA提交年度报告的百分比，以及每年INDS/IDE和持有INDS/IDE的新调查人员的总数。 RA小组有能力以电子方式提交IND。我们不知道有任何其他学术机构进行了这项投资。虽然FDA接受纸质和电子提交的监管文件，但他们长期以来一直主张并更喜欢使用电子提交来提高审查过程的效率和有效性。FDA的绩效目标被列为 2007年9月《处方药使用费法案》的重新授权包括使用电子提交，作为满足该机构审查时间表和业绩里程碑的一个关键目标。电子呈件的使用还为调查人员提供了一个显著的好处，因为它能够在内部和外部有效地存储、访问和共享监管文件。我们相信，杜克大学的电子提交系统将成为其他TRC-THD机构加强翻译研究努力的典范。

The Administrative Core will also provide dedicated regulatory oversight of the DTMI-CTHD Projects and Cores. While these services are available through the DTMI, they are predominantly an education and consultation basis. Because Project 2 will require the submission of an IND, we have incorporated regulatory personnel as part of the Administrative Core. The DTMI's Regulatory Affairs (RA) Group provides comprehensive support to Duke sponsor-investigators who hold active INDs, IDEs, and/or Biologic License Applications (BLAs). The RA staff works with researchers to determine when and what type of regulatory submission is needed for a particular research project and then to assemble and file the submission. The sponsor-investigators are guided through each step of the process and assisted as needed in developing protocols, informed consents, and monitoring plans. After the initial filing, RA staff members assist the sponsor investigator in fulfilling regulatory responsibilities for maintaining the IND/IDE, including periodic safety updates, annual reports, reports to the IRB, amendments, and any other reporting requirements. The RA group maintains a central database of all regulatory submissions made by Duke investigators. All sponsor-investigators are required by the IRB to register their INDs/lDEs with the RA group. This policy is enforced by the IRB during their initial or annual review of clinical protocols. All investigator-initiated studies must provide documentation that the IND or IDE has been registered with the RA group. This database includes the effective date of the IND or IDE, which enables the group to notify investigators of the requirement to submit an annual report on the anniversary of their IND or IDE submission. Investigators, in turn, are asked to provide confirmation that an annual report was filed. The database also allows the RA group to inform investigators of important changes and updates to FDA regulations and guidelines. The database is used to track the percentage of on-time annual reports to the FDA as well as the total number of INDs/IDEs and new investigators holding INDs/IDEs on an annual basis. The RA group has the capability to submit INDs electronically. We are not aware of any other academic institution that has made this investment. While the FDA accepts both paper and electronic submissions of regulatory documents, they have long advocated for and prefer the use of electronic submissions to increase the efficiency and effectiveness of the review process. The FDA's performance goals listed as part of the Prescription Drug User Fee Act reauthorization in September 2007 include the use of electronic submissions as a key objective in meeting the agency's review timelines and performance milestones. The use of electronic submissions also provides a significant benefit for investigators in its ability to efficiently store, access, and share regulatory documents both internally and externally. We believe that an electronic submission system at Duke will be a model for other TRC-THD institutions to enhance their translational research efforts.