Englisch

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

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

Non-Serious Adverse Events
Beschreibung

Non-Serious Adverse Events

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

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

Datentyp

boolean

If Yes, record details below.
Beschreibung

If Yes, record details below.

Datentyp

text

Non-Serious Adverse Events Chart
Beschreibung

Non-Serious Adverse Events Chart

Event
Beschreibung

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

Datentyp

integer

Start date
Beschreibung

Start date

Datentyp

date

Outcome
Beschreibung

e.g., 1

Datentyp

integer

End date
Beschreibung

End date

Datentyp

date

Frequency
Beschreibung

Frequency

Datentyp

integer

Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

text

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

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

Datentyp

text

Withdrawal
Beschreibung

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

Datentyp

boolean

Relationship to Investigational Product(s)
Beschreibung

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

Datentyp

boolean

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

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

Datentyp

text

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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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