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Training
Pages 21-24

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From page 21...
... Automated algorithms will be applied to this batch of data to detect potential problems with DAS functionality. The health checks will be generated and sent to the communications server at VTTI on a weekly basis starting on the day of installation of the DAS unit, unless some subsystem failure warrants immediate action.
From page 22...
... The training program will include classroom as well as hands-on training. Institutional Review Board Training Each individual who interacts with a human participant, or may come into contact with personal information or items belonging to a participant, must provide evidence of successful completion of standard IRB training.
From page 23...
... Topics will include, at a minimum, communication from the S06 manager on overall study issues and status as well as the same from each S07 manager, and action item assignment and follow-up. Critical Issues Committee A daily meeting time will be established where a critical issues committee can be quickly and reliably pulled together to address critical issues, which may include unexpected or abnormal situations that pose a risk to either an individual or group of participants, an individual or group of datacollection sites, or the study in its entirety.
From page 24...
... Example: Negative national publicity raises ire of Congressional leaders Example: Site loses all or most key employees in a short period of time Example: A si te contractor uses coercion to recruit family members Example: Catastrophic hacking event Meeting of Critical Issues Committee to enact/develop contingency plan to save project Notify relevant IR B(s) of adverse event; act on their directions Meeting of Critical Issues Committee to enact/develop contingency plan to save or terminate site Meeting of Critical Issues Committee and dB experts to determine extent of data exposure, develop strategy Yes Yes No No Yes No Handle with normal procedures (not an anomalous event)


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