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Unscheduled Visit: Non-Serious Adverse Events (AE) Form

1 Formulários  
Administrative data
Descrição

Administrative data

Subject Identifier
Descrição

Subject Identifier

Tipo de dados

integer

Non-Serious Adverse Events
Descrição

Non-Serious Adverse Events

Did the subject experience any non-serious events during the study?
Descrição

NOTE: If this is a Serious Adverse Event (SAE), do not complete this form, do to the SAE section and complete the SAE form.

Tipo de dados

boolean

If Yes, record details below.
Descrição

If Yes, record details below.

Tipo de dados

text

Non-Serious Adverse Events Chart
Descrição

Non-Serious Adverse Events Chart

Event
Descrição

Diagnosis only (if known) otherwise sign/symptom e.g., Headache

Tipo de dados

integer

Start date
Descrição

Start date

Tipo de dados

date

Outcome
Descrição

e.g., 1

Tipo de dados

integer

End date
Descrição

End date

Tipo de dados

date

Frequency
Descrição

Frequency

Tipo de dados

integer

Maximum Intensity
Descrição

Maximum Intensity

Tipo de dados

text

Action taken with Investigational Product(s) as a result of the Non-Serious AE
Descrição

Action taken with Investigational Product(s) as a result of the Non-Serious AE

Tipo de dados

text

Withdrawal
Descrição

Did the subject withdraw from study as a result of this AE?

Tipo de dados

boolean

Relationship to Investigational Product(s)
Descrição

Is there a reasonable possibility that the AE may have been caused by the investigational product?

Tipo de dados

boolean

Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
Descrição

Complete Study Conclusion page and mark Adverse event as reason for withdrawal.

Tipo de dados

text

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Similar models

Unscheduled Visit: Non-Serious Adverse Events (AE) Form

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Item Group
Non-Serious Adverse Events
Did the subject experience any non-serious events during the study?
Item
Did the subject experience any non-serious events during the study?
boolean
If Yes, record details below.
Item
If Yes, record details below.
text
Item Group
Non-Serious Adverse Events Chart
Item
Event
integer
Event
Code List
Event
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
CL Item
Event 5 (5)
CL Item
Event 6 (6)
CL Item
Event 7 (7)
CL Item
Event 8 (8)
Start date
Item
Start date
date
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End date
Item
End date
date
Item
Frequency
integer
Frequency
Code List
Frequency
CL Item
Single episode (1)
CL Item
Intermittent (2)
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action taken with Investigational Product(s) as a result of the Non-Serious AE
text
Action taken with Investigational Product(s) as a result of the Non-Serious AE
Code List
Action taken with Investigational Product(s) as a result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Withdrawal
Item
Withdrawal
boolean
Relationship to Investigational Product(s)
Item
Relationship to Investigational Product(s)
boolean
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
Item
Complete Study Conclusion page and mark Adverse event as reason for withdrawal.
text
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