Adminitrative Unit

Administrative Unit The central administrative core for NAMDC is located at Columbia University Medical Center, and is an intimate collaboration between the Merritt Center in the Department of Neurology and the Statistical Analysis Center (SAC) in the Department of Biostatistics. The Merritt Center provides clinical leadership, scientific expertise, and a strong relationship with the patient community; while the SAC provides expertise in the specialized biostatistics and study design required for rare diseases, a robust IT infrastructure, and years of experience in the logistics of developing and conducting collaborative research projects. Investigators and staff from the two organizations work together daily to form a unified central administrative core which provides clinical leadership for NAMDC investigators, design advice for the creation of new research, outreach to the patient community, logistical support for the consortium's activities, coordination among the various parts of NAMDC, and interaction with patient advocacy groups and the DMCC. The central administrative cores consists of Drs. Hirano and Thompson; in a consultative role, Dr. DiMauro; Ms. Sanford, who will address statistical and design issues, together with Dr. Thompson; Mr. Buchsbaum, who will oversee the websites, interaction with the DMCC, and data management for the clinical patient registry; Ms. Richards and Ms. Del Valle, financial administrators in the Merritt Center and the SAC, respectively; and, very significantly, Mr. Grier. who will serve as the full-time clinical coordinator for all NAMDC activities. Mr. Grier will coordinate the activities of the administrative core, and manage communications with all the constituent parts of NAMDC. He will oversee regulatory compliance, and assist NAMDC sites in receiving the necessary approvals for all NAMDC activities. He wilt serve as the primary clinical coordinator for the NAMDC clinical patient registry, act as clinical coordinator for all NAMDC research activities at Columbia, and assist coordinators and other staff at other clinical sites. We anticipate funding for Mr. Grier's position from UMDF, who will render a decision by July 1, 2011. When we receive the decision, we will inform NIH Program Officers. The administrative core sits at the center of several other administrative bodies, which contribute to and oversee NAMDC activities (Figure 1). To supervise the progress of the proposed programs, there will two committees: an Executive Committee, composed of the Director, Co-Director, 6 NAMDC site PIs, and the CEO/Executive Director of UMDF; and an External Advisory Committee, by necessity composed of non- American leaders in the mitochondrial clinical research, including Drs. Douglas Turnbull (Newcastle/Tyne, UK); Anu Suomalainen (Helsinki, Finland); Thomas Klopstock (Munich, Germany); Jan Smeitink (Nijmegen. The Netherlands); and Julio Montoya (Zaragoza, Spain). Both committees will meet annually on the occasion of the UMDF congress: because many, if not all, foreign scientists are invited faculty members. The Executive Committee will oversee all activities in NAMDC and provide feedback for the administrative core. The adoption of a new research project requires the approval of the Executive Committee, as does the inclusion of new clinical sites. (Both of these also require the approval of the RDCRN.)