The Seattle Flu Study: a multi-arm community-based prospective study protocol for assessing influenza prevalence, transmission, and genomic epidemiology

Helen Y. Chu; Michael Boeckh; Janet A. Englund; Michael Famulare; Barry R. Lutz; Deborah A Nickerson; Mark J. Rieder; Lea M Starita; Amanda Adler; Elisabeth Brandstetter; Chris D. Frazar; Peter D. Han; Reena K. Gularti; James Hadfield; Michael L. Jackson; Anahita Kiavand; Louise E. Kimball; Kirsten Lacombe; Jennifer Logue; Victoria Lyon; Kira L. Newman; Thomas R. Sibley; Monica L. Zigman Suschsland; Caitlin Wolf; Jay Shendure; Trevor Bedford

Data security and storage All information from the study subjects is kept confidential. All forms and specimens are assigned a participant identification number, given to the participant upon enrollment in the study, that will be used in the place of names whenever possible. Data will be collected electronically in a Title 21 CFR Part 11 compliant, password protected and auditable database. The list linking the participant to the ID number will be stored separately from the database. Access to identifiable information are limited to the study staff. Electronic files are secured via logon password protection for study accounts. Any datasets that include identifiable information are stored in a HIPAA-compliant manner. No identifying information is included on any data sent to the broader study team or any other data-sharing repositories. All data files transferred for this study will be transferred via encrypted software and the original files are kept on the server at the Fred Hutchinson Cancer Research Institute in a database.