title: DNA Commission of the International Society for Forensic Genetics: Recommendations on the validation of software programs performing biostatistical calculations for forensic genetics applications.
abstract: The use of biostatistical software programs to assist in data interpretation and calculate likelihood ratios is essential to forensic geneticists and part of the daily case work flow for both kinship and DNA identification laboratories. Previous recommendations issued by the DNA Commission of the International Society for Forensic Genetics (ISFG) covered the application of bio-statistical evaluations for STR typing results in identification and kinship cases, and this is now being expanded to provide best practices regarding validation and verification of the software required for these calculations. With larger multiplexes, more complex mixtures, and increasing requests for extended family testing, laboratories are relying more than ever on specific software solutions and sufficient validation, training and extensive documentation are of upmost importance. Here, we present recommendations for the minimum requirements to validate bio-statistical software to be used in forensic genetics. We distinguish between developmental validation and the responsibilities of the software developer or provider, and the internal validation studies to be performed by the end user. Recommendations for the software provider address, for example, the documentation of the underlying models used by the software, validation data expectations, version control, implementation and training support, as well as continuity and user notifications. For the internal validations the recommendations include: creating a validation plan, requirements for the range of samples to be tested, Standard Operating Procedure development, and internal laboratory training and education. To ensure that all laboratories have access to a wide range of samples for validation and training purposes the ISFG DNA commission encourages collaborative studies and public repositories of STR typing results.
authors.affiliation: National Institute of Standards and Technology, Applied Genetics Group, Gaithersburg, MD, USA. Electronic address: mcoble@nist.gov.
authors.forename: M D
authors.initials: MD
authors.lastname: Coble
authors.affiliation: ESR, Private Bag 92021, Auckland 1142, New Zealand; National Institute of Standards and Technology, Statistical Engineering Division (Guest Researcher), Gaithersburg, MD, USA.
authors.forename: J
authors.initials: J
authors.lastname: Buckleton
authors.affiliation: National Institute of Standards and Technology, Special Programs Office, Gaithersburg, MD, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Butler
authors.affiliation: Norwegian University of Life Sciences, Oslo, Norway.
authors.forename: T
authors.initials: T
authors.lastname: Egeland
authors.affiliation: Institute for Medical Statistics, Informatics, and Epidemiology, University Bonn, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Fimmers
authors.affiliation: Norwegian Institute of Public Health, Oslo, Norway; University of Oslo, Oslo, Norway.
authors.forename: P
authors.initials: P
authors.lastname: Gill
authors.affiliation: State University of Rio de Janeiro (UERJ), Rio de Janeiro, Brazil; IPATIMUP, Institute of Molecular Pathology and Immunology of the University of Porto, Portugal; Instituto de Investigação e Inovação em Saúde, University of Porto, Portugal.
authors.forename: L
authors.initials: L
authors.lastname: Gusmão
authors.affiliation: National Institute of Standards and Technology, Software and Systems Division, Gaithersburg, MD, USA.
authors.forename: B
authors.initials: B
authors.lastname: Guttman
authors.affiliation: Institute of Medical Informatics and Statistics, Christian-Albrechts University of Kiel, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Krawczak
authors.affiliation: Section of Forensic Genetics, Department of Forensic Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
authors.forename: N
authors.initials: N
authors.lastname: Morling
authors.affiliation: Institute of Legal Medicine, Medical University of Innsbruck, Innsbruck, Austria; Forensic Science Program, The Pennsylvania State University, PA, USA.
authors.forename: W
authors.initials: W
authors.lastname: Parson
authors.affiliation: IPATIMUP, Institute of Molecular Pathology and Immunology of the University of Porto, Portugal; Instituto de Investigação e Inovação em Saúde, University of Porto, Portugal; Institute for Research and Innovation in Health (I3S), University of Porto, Porto, Portugal; Centre of Mathematics of the University of Porto, Porto, Portugal.
authors.forename: N
authors.initials: N
authors.lastname: Pinto
authors.affiliation: Institute of Legal Medicine, Faculty of Medicine, University of Cologne, Germany.
authors.forename: P M
authors.initials: PM
authors.lastname: Schneider
authors.affiliation: National Center for Biotechnology Information, National Library of Medicine, NIH, Bethesda, MD, USA.
authors.forename: S T
authors.initials: ST
authors.lastname: Sherry
authors.affiliation: Department of Forensic Genetics, Institute of Legal Medicine and Forensic Sciences, Charité-Universitätsmedizin, Berlin, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Willuweit
authors.affiliation: John Jay College of Criminal Justice, New York, USA.
authors.forename: M
authors.initials: M
authors.lastname: Prinz
mesh_terms: D026683:Advisory Committees; D056808:Biostatistics; D053803:Forensic Genetics; D006801:Humans; D015203:Reproducibility of Results; D012958:Societies, Scientific; D012984:Software / Q000592:standards*
keywords: Biostatistical software; Forensic genetics; Software training and testing; Software validation; Validation and verification