Saturday, May 18, 2024
5/18/2024
Project Summary The Data Coordinating Center (DCC) selected in response to the RFA will coordinate multiple clinical trials involving the evaluation of the efficacy and safety of artificial pancreas (AP) systems for adults or children with type 1 diabetes. A DCC is essential for a multi-center clinical trial. This is especially true when the studies coordinated by the DCC will involve investigational devices as will likely be the case for this project. The Jaeb Center for Health Research (JCHR) has 18 years’ experience with studies in type 1 diabetes, including the coordination of numerous AP studies over the last 10 years funded by NIDDK, JDRF, Helmsley Charitable Trust, and industry. JCHR as an institution and the key staff for this project have the expertise and extensive experience needed for the DCC to ensure a successful project. JCHR’s computing environment, and Standard Operating Procedure (SOP) documents, instruction manuals, and materials developed for prior projects will be utilized to facilitate the development and conduct of this project. JCHR has a substantial core of Informational Technology, Quality Assurance, Contracts, IRB, Accounting, and General Operations staff who support all of its projects and complement the effort of the staff who are assigned to this project. The specific aim for this project will be development of a DCC for each AP study separately funded by NIDDK. The functions and responsibilities of the DCC are extensive as described in Research Strategy section 3 and will include the following: • coordinating the efforts of the clinical sites • many administrative functions • assuring that each trial is conducted with maximum protection for human subjects’ safety and confidentiality, including review and reporting of adverse events and device issues • assuring data quality through both remote and on-site monitoring • developing regulatory-compliant processes for the collection, management, and analysis of study data; device accountability; regulatory reporting; financial conflict of interest reporting • dissemination of study results
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