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Clinical Islet Transplantation Study (CIT)

Background (cont.)
These trials have been designed to accomplish the following goals:
1. Increasing the efficiency of islet transplantation, with the goal of achieving successful single-donor islet transplantation.

2. Improvements in immunotherapy to reduce toxicity, recurrent autoimmunity and allograft rejection.

3. FDA licensure of the human islet product.

DCC Responsibilities
The Data Coordinating Center for the consortium provides support in the following areas:

1) Study Design, Conduct, Analyses, and Publications - The DCC provides statistical leadership for the consortium. It oversees implementation of the current clinical trials and implements the statistical analysis plans that have been submitted to the FDA, and is responsible for assisting with all updates to the protocols and manuals of operation; implementation and, where necessary, modification of the existing data safety and monitoring plans; collaborating with the NIAID Regulatory and Medical staff to implement the existing procedures for reporting of Serious Adverse Events; performing interim analyses of safety and efficacy for protocol teams, NIH, and the Data Safety and Monitoring Board (DSMB); generating executive summaries of study results for use by the protocol team, NIH, and collaborators; conducting the final analyses and participating on publication writing teams; performing cross-protocol or cross study analyses utilizing data from multiple sources within and external to the consortium; producing study monitoring reports for the consortium and NIH; and conducting analyses and summaries for annual and interim reports for NIH-sponsored Investigational New Drug Applications, in cooperation with the NIAID Regulatory staff.

2) Data Management - The DCC provides central registration and randomization (as required by study protocols) for all study subjects; develops/modifies case report forms and standardized criteria for clinical endpoint verification; maintains, designs and implements systems for the efficient tracking and transfer of clinical and laboratory data (including quality assurance and specimen tracking) to the central database; provides data management training to the clinical sites and laboratories; provides for central storage, security, processing and retrieval of study results; and prepares selected public access databases.

3) Site Monitoring - Through a subcontract Clinical Research Organization(s), the DCC initiates, monitors, and closes out clinical sites, pharmacies, and laboratories to assure Good Clinical/Laboratory Practice (GCP/GLP); together with NIAID regulatory staff, trains site personnel on GCP/GLP/GTP compliance and on the policies and procedures established by the NIH, the Food and Drug Administration (FDA), and the Office of Human Research Protections (OHRP); audits clinical, pharmacy, and laboratory sites, as well as islet facilities, as necessary; and provides reports to the NIH and the Steering Committee on monitoring and audit findings and training activities.

4) Administrative Support - The DCC organizes meetings and teleconferences; provides core laboratory support and coordination, including specimen handling and distributes study drugs and supplies.

5) Regulatory Requirements - The DCC works in concert with the NIAID Regulatory Affairs Staff and/or Support Contractor and NIH staff by providing them with clinical study data, reports, and other support as required for Adverse Event Reporting and IND submissions.

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