Engels

Visit 4: Study Continuation Check

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Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Check for Study Continuation
Beschrijving

Check for Study Continuation

Did the subject return for visit 4?
Beschrijving

Did the subject return for visit 4?

Datatype

boolean

If yes, please complete all forms for Visit 2
Beschrijving

If yes, please complete all forms for Visit 2

Datatype

text

If No, record ONE most appropriate reason and skip the following pages of this visit
Beschrijving

If No, record ONE most appropriate reason and skip the following pages of this visit

Datatype

text

If SAE, record the SAE number
Beschrijving

If SAE, record the SAE number

Datatype

integer

If Non-SAE, record the unsolicited AE number
Beschrijving

If Non-SAE, record the unsolicited AE number

Datatype

integer

If Other, specify
Beschrijving

e.g., consent withdrawal, protocol violation, etc.

Datatype

text

Who took the decision?
Beschrijving

Who took the decision?

Datatype

text

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Similar models

Visit 4: Study Continuation Check

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 4?
Item
Did the subject return for visit 4?
boolean
If yes, please complete all forms for Visit 2
Item
If yes, please complete all forms for Visit 2
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
If No, record ONE most appropriate reason and skip the following pages of this visit
Code List
If No, record ONE most appropriate reason and skip the following pages of this visit
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If Non-SAE, record the unsolicited AE number
Item
If Non-SAE, record the unsolicited AE number
integer
If Other, specify
Item
If Other, specify
text
Item
Who took the decision?
text
Who took the decision?
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
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