Rationale and Development of a Data Coordinating Center to Support the Type 1 Diabetes in Acute Pancreatitis Consortium

Abstract

A data coordinating center (DCC) is a critical member of any multicenter research undertaking, and that is especially true for the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). We describe how the T1DAPC DCC supports the consortium via its experience and expertise in project management, administration, financial management, regulatory compliance, scientific coordination, data management, research computing, and biostatistics and in facilitating scientific publications. The DCC's matrix management system has been extremely effective in managing all of its responsibilities. The first 16 months in the life of the T1DAPC have been dedicated to the development of its first protocol, titled Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM), addressing the institutional review board and regulatory components, developing the T1DAPC data management system, and providing training and certification of clinical center staff. As a result of its efforts, the DCC was a major contributor to the T1DAPC being able to initiate recruitment for the DREAM study in January 2022.

Healthcare disparities in pancreatitis: knowledge gaps and next steps

“…Interdisciplinary research teams are crucial for increasing minority representation and revealing the underlying reasons for health inequities in pancreatitis. This approach is likely to have an impact on multiple levels: investigators with expertise in health inequities can help to develop and adapt case report forms for data collection to study health inequities, inclusion of experts who worked with pancreatitis patients within minority communities can contribute to the development of a tailored RRP to improve minority representation [59 & ], presence of a Data Coordinating Center (DCC), crucial for multicenter studies in improving scientific coordination and research computing to facilitate inclusion and analysis health inequities-related data [63], and development and adaptation of novel conceptual frameworks to examine the underlying structural factors for health inequities in pancreatitis. A recent study by Sarraf et al [13 && ] showed the importance of an interdisciplinary collaborative approach for the adaptation of such frameworks, including the Social Vulnerability Index (SVI) and structural violence (StV) for pancreatitis.…”

Rationale and Design for the Diabetes RElated to Acute Pancreatitis and Its Mechanisms Study

“…12 In addition to these teams, the data coordinating center provides central administrative, regulatory, and statistical support for T1DAPC, including the DREAM. 20 In accordance with National Institutes of Health (NIH) policies, the study is approved through a single institutional review board, and reviewed on a biannual basis by an NIH-appointed data and safety monitoring board.…”

“…Investigators have formed a combination of working groups and committees that worked collaboratively in an iterative manner to develop the DREAM study protocol and execution plans, as previously introduced 12 . In addition to these teams, the data coordinating center provides central administrative, regulatory, and statistical support for T1DAPC, including the DREAM 20 . In accordance with National Institutes of Health (NIH) policies, the study is approved through a single institutional review board, and reviewed on a biannual basis by an NIH-appointed data and safety monitoring board.…”

Standard Operating Procedures for Biospecimen Collection, Processing, and Storage

“…The sample tracking (ST) module of the DCC data management system 12 serves as the bioinformatics data management system in T1DAPC. In ST, users can generate sample specific barcoded labels.…”