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Adverse Events (AE) for Sessions

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Adverse event
Beschreibung

Adverse event

Alias
UMLS CUI-1
C0877248
Planned relative time
Beschreibung

Note: Tick "+2h and +6h" only for Day 1. "+16h" is for Day 2 mandatory.

Datentyp

integer

Alias
UMLS CUI [1]
C0439564
Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Time
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Have any Adverse Events been observed/reported?
Beschreibung

If YES, please complete the "Adverse Event" form.

Datentyp

text

Alias
UMLS CUI [1]
C0877248
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Ähnliche Modelle

Adverse Events (AE) for Sessions

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Planned relative time
Code List
Planned relative time
CL Item
+2h (1)
CL Item
+6h (2)
CL Item
+16h (3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time
time
C0040223 (UMLS CUI [1])
Item
Have any Adverse Events been observed/reported?
text
C0877248 (UMLS CUI [1])
Adverse event observed
Code List
Have any Adverse Events been observed/reported?
CL Item
No (N)
CL Item
Yes (Y)
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