Administrative, Regulatory and Cord Blood Bank

$46,022P01FY2014CANIH

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications & trials

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Abstract

The goals of this core are to provide all projects and the other cores with centralized leadership, administrative. Cord Blood Bank and clinical research support. The Administrative component will be responsible for integrating all components of the program project grant (PO1) and overseeing progress, so that the research objectives are being met. It will provide assistance to each project and core leader with budgetary issues and will oversee the overall fiscal and budgetary management of the program. This Core will also coordinate oversight of the PO1 by convening meetings of the Internal and External Advisory Boards and implementing their recommendations. The goals of the clinical research component of this core are to provide all projects with clinical trial support in collaboration with Core B and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/OBA and annual reports. This core has extensive experience with IND submission and currently supports over 45 IND studies. The Quality Control program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The Quality Assurance program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The MD Anderson Cord Blood Bank is committed to providing cord blood units for pre-clinical peer-reviewed research to advance the field of cord blood transplantation, and will provide all the cord blood units needed to execute the studies proposed in the projects. In this PO1 we have developed strategic approaches to overcome the limitations of cord blood transplantation and will rely on testing potential solutions in carefully designed preclinical models and then translating the results to the clinic.

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