Visit 3: Study Continuation Check

Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Check for Study Continuation
Beschreibung

Check for Study Continuation

Did the subject return for visit 3?
Beschreibung

Did the subject return for visit 3?

Datentyp

boolean

If yes, please complete all forms for Visit 3
Beschreibung

If yes, please complete all forms for Visit 3

Datentyp

text

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

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

Datentyp

text

If SAE, record the SAE number
Beschreibung

If SAE, record the SAE number

Datentyp

integer

If Non-SAE, record the unsolicited AE number
Beschreibung

If Non-SAE, record the unsolicited AE number

Datentyp

integer

If Other, specify
Beschreibung

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

Datentyp

text

Who took the decision?
Beschreibung

Who took the decision?

Datentyp

text

Ähnliche Modelle

Visit 3: Study Continuation Check

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 3?
Item
Did the subject return for visit 3?
boolean
If yes, please complete all forms for Visit 3
Item
If yes, please complete all forms for Visit 3
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
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
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)