Administrative Coordinating Center

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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.