Example Case Report Forms for CE domain
Sources: DB1 | Forms loaded: 3
Form: Device related physical activity and stress
Show domain info
Primary Domain
CE
All Domains
CE
# Question Response
1
Did the subject experience any unusual physical activity or stress because of wearing the device?
field_001
2
Did the subject any unusual physical activity or stress because of wearing the device?
field_002
3
Did the subject experience unusual physical activity?
field_003
4
Start date of unusual physical activity
field_004
5
Start time of unusual physical activity
field_005
6
Stop date of unusual physical activity
field_006
7
Stop time of unusual physical activity
field_007
8
Did the subject experience a stressful event?
field_008
9
Start date of stressful event
field_009
10
Start time of stressful event
field_010
11
Stop date of stressful event
field_011
12
Stop time of stressful event
field_012
Example Case Report Forms for CE domain
Sources: DB1 | Forms loaded: 3
Form: Falls
Show domain info
Primary Domain
CE
All Domains
CE, FA
# Question Response
1
Did the patient fall since last visit?
field_001
2
Date of fall
field_002
3
Time of the day
field_003
4
Environment (of fall)
field_004
5
Activity at the time of fall
field_005
6
Fall Mechanism
field_006
7
Did the fall result in injury
field_007
8
Severity of the injury
field_008
9
field_009
Example Case Report Forms for CE domain
Sources: DB1 | Forms loaded: 3
Form: Ce Hypoglyc
Show domain info
Primary Domain
CE
All Domains
CE, FA
# Question Response
1
Did subject have any hypoglycemic events since the last visit?
field_001
2
Sequence Identifier
field_002
3
Hypoglycemic event start date
field_003
4
Hypoglycemic event start time
field_004
5
What was the date of last study treatment before the event?
field_005
6
What was the time of last study treatment before the event?
field_006
7
What was the subject's awareness of the hypoglycemic event?
field_007
8
Blood glucose concentration measured prior to treating the event?
field_008
9
If measured, what is the blood glucose concentration
field_009
10
Unit of blood glucose concentration measurement
field_010
11
Were signs/symptoms of hypoglycemia present, other than the blood glucose reading?
field_011
12
What was the hypoglycemic event outcome?
field_012
13
Specify if outcome is other
field_013
14
Was treatment given because of the occurrence of the event?
field_014
15
If yes, how was the hypoglycemic event treatment
field_015
16
field_016