Visit 4: Study Continuation Check

Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Check for Study Continuation
Descripción

Check for Study Continuation

Did the subject return for visit 4?
Descripción

Did the subject return for visit 4?

Tipo de datos

boolean

If yes, please complete all forms for Visit 2
Descripción

If yes, please complete all forms for Visit 2

Tipo de datos

text

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

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

Tipo de datos

text

If SAE, record the SAE number
Descripción

If SAE, record the SAE number

Tipo de datos

integer

If Non-SAE, record the unsolicited AE number
Descripción

If Non-SAE, record the unsolicited AE number

Tipo de datos

integer

If Other, specify
Descripción

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

Tipo de datos

text

Who took the decision?
Descripción

Who took the decision?

Tipo de datos

text

Similar models

Visit 4: Study Continuation Check

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
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)