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Example Case Report Forms for CE domain


Form: Device related physical activity and stress

Question Response
Did the subject experience any unusual physical activity or stress because of wearing the device?
Did the subject any unusual physical activity or stress because of wearing the device?
Did the subject experience unusual physical activity?

Start date of unusual physical activity
Start time of unusual physical activity
Stop date of unusual physical activity
Stop time of unusual physical activity
Did the subject experience a stressful event?

Start date of stressful event
Start time of stressful event
Stop date of stressful event
Stop time of stressful event

Form: Falls

Question Response
Did the patient fall since last visit?


Date of fall
Time of the day




Environment (of fall)




Activity at the time of fall




Fall Mechanism





Did the fall result in injury

Severity of the injury



Form:

Question Response
Did subject have any hypoglycemic events since the last visit?

Sequence Identifier
Hypoglycemic event start date
Hypoglycemic event start time
What was the date of last study treatment before the event?
What was the time of last study treatment before the event?
What was the subject's awareness of the hypoglycemic event?


Blood glucose concentration measured prior to treating the event?

If measured, what is the blood glucose concentration
Unit of blood glucose concentration measurement

Were signs/symptoms of hypoglycemia present, other than the blood glucose reading?


What was the hypoglycemic event outcome?






Specify if outcome is other
Was treatment given because of the occurrence of the event?

If yes, how was the hypoglycemic event treatment