Inglês

Visit 4: Study Continuation Check

1 Formulários  
Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Check for Study Continuation
Descrição

Check for Study Continuation

Did the subject return for visit 4?
Descrição

Did the subject return for visit 4?

Tipo de dados

boolean

If yes, please complete all forms for Visit 2
Descrição

If yes, please complete all forms for Visit 2

Tipo de dados

text

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

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

Tipo de dados

text

If SAE, record the SAE number
Descrição

If SAE, record the SAE number

Tipo de dados

integer

If Non-SAE, record the unsolicited AE number
Descrição

If Non-SAE, record the unsolicited AE number

Tipo de dados

integer

If Other, specify
Descrição

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

Tipo de dados

text

Who took the decision?
Descrição

Who took the decision?

Tipo de dados

text

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Similar models

Visit 4: Study Continuation Check

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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