Inglese

Visit 2: Study Continuation Check

1 moduli  
Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Protocol Number
Descrizione

Protocol Number

Tipo di dati

integer

Check for Study Continuation
Descrizione

Check for Study Continuation

Did the subject return for visit 2?
Descrizione

Did the subject return for visit 2?

Tipo di dati

boolean

If yes, please complete all forms for Visit 2
Descrizione

If yes, please complete all forms for Visit 2

Tipo di dati

text

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

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

Tipo di dati

text

If SAE, record the SAE number
Descrizione

If SAE, record the SAE number

Tipo di dati

integer

If Non-SAE, record the unsolicited AE number
Descrizione

If Non-SAE, record the unsolicited AE number

Tipo di dati

integer

If Other, specify
Descrizione

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

Tipo di dati

text

Who took the decision?
Descrizione

Who took the decision?

Tipo di dati

text

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Similar models

Visit 2: Study Continuation Check

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 2?
Item
Did the subject return for visit 2?
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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