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These data will be documented and reported as adverse events.
Data will be documented in line with 'Good Clinical Practice' and Dutch legal requirements.
The initial ED assessment data will be documented prior to management decisions.
The reasons for missing data will be documented and the mechanism for missing data will be examined [ 34].
Data will be documented anonymously in a case report file (CRF), which will be stored at the University Medical Center Freiburg for 10 years.
Baseline data will be documented including demographics, medical history, current medication, metabolic, liver and renal function as well as history of renal treatment.
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This information will be documented on the data collection sheets.
Data changes will be documented.
Any amendments to the data set will be documented.
Any changes to data points will be documented to ensure a clear audit trail.
The patient will be re-evaluated every hour thereafter, and data about extubation will be documented.
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