English

Check for study continuation

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Check for study continuation
Description

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
Did the subject return for the Visit?
Description

If you tick "no" please complete the following items.

Data type

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Reason for no return
Description

Please tick the one most appropriate reason. If you tick: 1) SAE: Please complete and submit SAE report, 2) Non-serious AE: Please complete Non-serious Adverse Event section

Data type

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
If other Reason for no return to study, please specify
Description

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

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C0805733
SAE Number
Description

Fill in if you ticked SAE as reason for no continuation

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
Non-serious AE Number
Description

Fill in if you ticked Non-serious AE as reason for no continuation

Data type

text

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Solicited AE Number
Description

Fill in if you ticked Solicited AE as reason for no continuation

Data type

text

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C0877248
UMLS CUI [1,3]
C0237753
Please tick who made the decision
Description

Decision maker

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
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Similar models

Check for study continuation

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
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)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Visit Day 21 (all WB's) (1)
CL Item
Visit Day 42 (WB3+4) (2)
CL Item
Visit Month 6 (all WB's) (3)
CL Item
Visit Month 6+7D (WB1+3) (4)
CL Item
Visit Month 6+21D (WB1+3) (5)
CL Item
Visit Month 12 (all WB's) (6)
CL Item
Visit Month 12+7D (WB2+4) (7)
CL Item
Visit Month 12+21D (WB2+4) (8)
CL Item
Visit Month 18 (all WB's) (9)
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Item
Did the subject return for the Visit?
text
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Return to study
Code List
Did the subject return for the Visit?
CL Item
Yes (Y)
CL Item
No (N)
Item
Reason for no return
text
C0392360 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
Reason for no return
Code List
Reason for no return
CL Item
Serious adverse event (SAE)
CL Item
Non-Serious adverse event (AEX)
CL Item
Other (OTH)
Other Reason
Item
If other Reason for no return to study, please specify
text
C3840932 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C0805733 (UMLS CUI [1,3])
SAE Number
Item
SAE Number
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-serious AE Number
Item
Non-serious AE Number
text
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Solicited AE Number
Item
Solicited AE Number
text
C1517001 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Item
Please tick who made the decision
text
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Decision maker
Code List
Please tick who made the decision
CL Item
Investigator (I)
CL Item
Subject (S)
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