The GLIA-CTN Administrative Unit will coordinate all consortium activities and finances and will set general policies and procedures in collaboration with the RDCRN and Office of Rare Disorders (ORD)/ National Institutes of Child Health and Development (NICHD). In addition, the Unit will serve as the administrative center for the Data Integration Core of the Consortium, to centralize the ability of the GLIA-CTN to collect from and deliver data to relevant stakeholders, including the RDCRN DMCC, patient advocacy partners and industry collaborators. The Administrative Unit will also be responsible for all regulatory activities of GLIA: ongoing evaluation of productivity at sites; oversight of all projects including pilot projects; and oversight of the career development program. In addition, the Unit will be responsible for NIH and federal compliance, such as implementation of regulatory activities, observance of NIH and federal policies regarding human subject protections, Health Insurance Portability and Accountability Act (HIPAA) stipulations, and the inclusion of women, minorities and children. Details of implementation within the Administrative Unit are described below and include the chain of command for decision-making and administration, the reporting structure, the communication plan, as well as for the overall integration of GLIA with RDCRN activities. This component describes the key roles of the Administrative Unit, as well as the governance of the GLIA-CTN, the use of a Data Integration Core, all committees and the mechanisms for collaboration with the patient advocacy groups.
Closely aligned with the mission of RDCRN, the purpose of the Global Leukodystrophy Initiative Clinical Trials Network (GLIA-CTN) is to advance the diagnosis, management, and treatment of individuals affected by leukodystrophies. The proposed Administrative Unit of GLIA-CTN will apply these common principals to facilitate a global consortium across academic centers, patient advocacy groups, and industry partners. The Administrative Unit seeks to support the network in the next era of research efforts, moving towards to clinical trials.
