Adverse Event Tracking Log: CRF Wisconsin Madison

Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Subject ID
Beskrivning

Subject ID

Datatyp

integer

Number of Page
Beskrivning

Number of Page

Datatyp

integer

Total Number of Pages
Beskrivning

Total Number of Pages

Datatyp

integer

Adverse Event Tracking Log
Beskrivning

Adverse Event Tracking Log

Beskrivning

#

Datatyp

integer

Date Reported
Beskrivning

Date Reported

Datatyp

date

Adverse Event Description
Beskrivning

Adverse Event Description

Datatyp

text

Adverse Event Category
Beskrivning

Adverse Event Category

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

End Date
Beskrivning

End Date

Datatyp

date

Outcome
Beskrivning

0= Fatal 1= Not recovered/not resolved 2= Recovered w/sequelae 3= Recovered w/o sequelae 4= Recovering/Resolving

Datatyp

text

Severity / Grade
Beskrivning

1= Mild 2= Moderate 3= Severe 4= Life threatening 5= Fatal

Datatyp

text

Serious
Beskrivning

Serious

Datatyp

boolean

Expected
Beskrivning

Expected

Datatyp

boolean

AE Treatment
Beskrivning

0= None 1= Medication(s) 2= Non-medication TX

Datatyp

text

Action Taken
Beskrivning

0= None 1= Interrupted 2= Discontinued 3= Dose reduced 4= Dose increased 5= Not Applicable

Datatyp

text

Attribution
Beskrivning

0= Definite 1= Probable 2= Unlikely 3= Unrelated

Datatyp

text

PI Initials
Beskrivning

PI Initials

Datatyp

text

Date of PI Initials
Beskrivning

Date of PI Initials

Datatyp

date

Similar models

Adverse Event Tracking Log: CRF Wisconsin Madison

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
PI Name
Item
PI Name
text
Protocol or IRB Number
Item
Protocol or IRB Number
integer
Protocol Short Title
Item
Protocol Short Title
text
Subject Initials
Item
Subject Initials
text
Subject ID
Item
Subject ID
integer
Number of Page
Item
Number of Page
integer
Total Number of Pages
Item
Total Number of Pages
integer
Item Group
Adverse Event Tracking Log
#
Item
#
integer
Date Reported
Item
Date Reported
date
Adverse Event Description
Item
Adverse Event Description
text
Adverse Event Category
Item
Adverse Event Category
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Outcome
Item
Outcome
text
Severity / Grade
Item
Severity / Grade
text
Serious
Item
Serious
boolean
Expected
Item
Expected
boolean
AE Treatment
Item
AE Treatment
text
Action Taken
Item
Action Taken
text
Attribution
Item
Attribution
text
PI Initials
Item
PI Initials
text
Date of PI Initials
Item
Date of PI Initials
date