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We know from the WikiLeaks case that among the legions of Internet aggregators and disseminators are at least a few who would feel no compunction about disclosing life-threatening information if they got their hands on it.
The emergency data contains a life threatening vital signs information such as low or high threshold value of a heartbeat.
All other SUSARs: not later than 15 days after the sponsor had information that the case fulfilled the criteria for a SUSAR Fatal or life threatening SUSARs: not later than 7 days after the sponsor had information that the case fulfilled the criteria for a fatal or life threatening SUSAR, and any follow up information within a further 8 days.
All SUSARS must be reported in an expedited fashion to the MHRA and Ethics Committee Fatal or life threatening SUSARs: not later than 7 days after the sponsor had information that the case fulfilled the criteria for a fatal or life threatening SUSAR, and any follow up information within a further 8 days.
Since toxic effects of pharmacological compounds on the normal vasculature might cause life threatening hemorrhages, this might provide valuable information during the pre-clinical testing phase.
The problem at present is that we cannot predict which DCIS will become potentially life threatening although this is likely to change with additional information from molecular markers.
However being a patient with a potentially life threatening condition puts a considerable strain on their ability to process information.
Beside regular physical and laboratory checks in the outpatient clinic, information on the daily health status is mandatory for early detection of possible life threatening complication.
"It's not life threatening.
Bulimia is potentially life threatening.
For them this is life threatening.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com