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Given the relatively consistent characteristics and challenges of ancillary study management, general-purpose ASMSs are likely to be useful to a wide range of organizations. The scenarios and requirements we describe can help guide the development of systems that make conducting ancillary studies easier, less expensive, and less error-prone. For an ASMS to address these characteristics, it would need to address both operational requirements ( e.g., allocating existing specimens) and data management requirements ( e.g., securely distributing and integrating primary and ancillary data). Distinguishing characteristics of ancillary studies may include the collection of additional measurements (particularly new analyses of existing specimens) the initiation of studies by investigators unaffiliated with the original study cross-protocol data pooling and analysis pre-existing participant consent and pre-existing data context and provenance. Resultsīy exploring characteristics of ancillary studies, we identify differentiating requirements and scenarios for ancillary study management systems (ASMSs). Lastly, to enhance breadth, we reviewed process documents for ancillary study management from other organizations. We also consulted with researchers at a range of other disease research organizations regarding their workflows and data management strategies. Military HIV Research Program (MHRP), and the Network for Pancreatic Organ Donors with Diabetes (nPOD). These organizations include the Center for HIV/AIDS Vaccine Immunology (CHAVI), the Immune Tolerance Network (ITN), the HIV Vaccine Trials Network (HVTN), the U.S. We have identified requirements for ancillary study management primarily as part of our ongoing work with a number of large research consortia. General-purpose software systems that simplify the management of ancillary studies have not yet been explored in the research literature. It requires coordinating across institutions, sites, repositories, and approval boards, as well as distributing, integrating, and analyzing diverse data types. However, management of such follow-on, “ancillary” studies is complex.

The valuable clinical data, specimens, and assay results collected during a primary clinical trial or observational study can enable researchers to answer additional, pressing questions with relatively small investments in new measurements.

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