title: Ancillary study management systems: a review of needs.
abstract: BACKGROUND
  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. However, management of such follow-on, "ancillary" studies is complex. It requires coordinating across institutions, sites, repositories, and approval boards, as well as distributing, integrating, and analyzing diverse data types. General-purpose software systems that simplify the management of ancillary studies have not yet been explored in the research literature.
  
  
  METHODS
  We have identified requirements for ancillary study management primarily as part of our ongoing work with a number of large research consortia. 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. Military HIV Research Program (MHRP), and the Network for Pancreatic Organ Donors with Diabetes (nPOD). We also consulted with researchers at a range of other disease research organizations regarding their workflows and data management strategies. Lastly, to enhance breadth, we reviewed process documents for ancillary study management from other organizations.
  
  
  RESULTS
  By exploring characteristics of ancillary studies, we identify differentiating requirements and scenarios for ancillary study management systems (ASMSs). 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. 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).
  
  
  CONCLUSIONS
  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. 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. Using the requirements identified in this paper, we are currently developing an open-source, general-purpose ASMS based on LabKey Server (http://www.labkey.org) in collaboration with CHAVI, the ITN and nPOD.
authors.affiliation: LabKey Software, Seattle, WA, USA. eknelson@labkey.com
authors.forename: Elizabeth K
authors.initials: EK
authors.lastname: Nelson
authors.forename: Britt
authors.initials: B
authors.lastname: Piehler
authors.forename: Adam
authors.initials: A
authors.lastname: Rauch
authors.forename: Sarah
authors.initials: S
authors.lastname: Ramsay
authors.forename: Drienna
authors.initials: D
authors.lastname: Holman
authors.forename: Smita
authors.initials: S
authors.lastname: Asare
authors.forename: Adam
authors.initials: A
authors.lastname: Asare
authors.forename: Mark
authors.initials: M
authors.lastname: Igra
mesh_terms: D035843:Biomedical Research / Q000379:methods*; D006801:Humans; D012984:Software