Englisch

Check for study continuation

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Workbook Number
Beschreibung

Workbook Number

Datentyp

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Check for study continuation
Beschreibung

Check for study continuation

Alias
UMLS CUI-1
C2348568
UMLS CUI-2
C0805733
Did the subject return for this visit?
Beschreibung

Subject's return

Datentyp

text

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
If subject did not return, please tick the ONE most appropriate reason
Beschreibung

If you tick SAE: Please complete and submit SAE report If you tick AEX: Please complete Non-serious Adverse Event section

Datentyp

text

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0566251
If you ticked SAE as reason for no continuation, please specify SAE Number
Beschreibung

SAE Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C1519255
If you ticked AE as reason for no continuation, please specify AE Number or solicited AE code.
Beschreibung

AE Number/ solicited AE code

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0600091
UMLS CUI [2,1]
C0877248
UMLS CUI [2,2]
C0805701
If you ticked Other as reason for no continuation, please specify
Beschreibung

(e.g.: consent withdrawal, Protocol violation, …)

Datentyp

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
Please tick who made the decision
Beschreibung

Decision taken

Datentyp

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
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Ähnliche Modelle

Check for study continuation

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Workbook Number
Code List
Visit type
CL Item
Visit 2 (1)
CL Item
Visit 3 (2)
CL Item
Visit 4 (3)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Check for study continuation
C2348568 (UMLS CUI-1)
C0805733 (UMLS CUI-2)
Item
Did the subject return for this visit?
text
C0681850 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Subject's return
Code List
Did the subject return for this visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
If subject did not return, please tick the ONE most appropriate reason
text
C1298908 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
No continuation, reason
Code List
If subject did not return, please tick the ONE most appropriate reason
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
SAE Number
Item
If you ticked SAE as reason for no continuation, please specify SAE Number
integer
C0600091 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
AE Number/ solicited AE code
Item
If you ticked AE as reason for no continuation, please specify AE Number or solicited AE code.
integer
C0877248 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2,1])
C0805701 (UMLS CUI [2,2])
Other reason
Item
If you ticked Other as reason for no continuation, please specify
text
C3840932 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0679006 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
Decision taken
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Parent/Guardians (P)
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