This proposal is submitted in response to RFA-HL-06-108 for the Limited Competition for the Continuation of the Transfusion Medicine /Hemostasis Clinical Research Network, a nationally developed network of interactive clinical research groups. With this application, the Transfusion Medicine Program at Emory University seeks to continue funding as a Core Clinical Center within the Network. As a Core Clinical Center we have and will continue to contribute scientific concepts and to protocol development;participate in the overall administration of the clinical trials through the national Steering Committee and Data Coordinating Center;adhere to national and institutional guidelines and regulatory requirements related to research involving human subjects;accrue eligible patients to trials selected to be conducted by the Network;and disseminate findings through timely publications and presentations of data. As a Core Clinical Center of the Clinical Research Network we will continue to pursue the following Specific Aims, to: 1) maintain, and further develop, as needed, a structure to support the development, implementation and conduct of clinical trials in the areas of transfusion medicine and hemostasis. This will be done in collaboration with the New England Research Institutes as Data Coordinating Center, and program staff at NHLBI;2) utilizing a structure of working and study oversight subcommittees, complete ongoing trials and develop, refine and complete new trials proposed in this application;3) develop collaborative relationships and support training opportunities to facilitate the success of the proposed clinical trials and further the fields of transfusion medicine and hemostasis. Over the past 5 years, Emory University investigators have actively participated at Steering Committee meetings, enrolled patients on the PLADO trial, obtained IRB approval for SHIP, and continued to work on obtaining IRB approval for the RICH trial. The Emory Core Clinical Center has developed the personnel and procedures to ensure optimal participation and future productivity.
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