Adverse Event Tracking Log: CRF Wisconsin Madison

Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Subject ID
Descripción

Subject ID

Tipo de datos

integer

Number of Page
Descripción

Number of Page

Tipo de datos

integer

Total Number of Pages
Descripción

Total Number of Pages

Tipo de datos

integer

Adverse Event Tracking Log
Descripción

Adverse Event Tracking Log

Descripción

#

Tipo de datos

integer

Date Reported
Descripción

Date Reported

Tipo de datos

date

Adverse Event Description
Descripción

Adverse Event Description

Tipo de datos

text

Adverse Event Category
Descripción

Adverse Event Category

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

End Date
Descripción

End Date

Tipo de datos

date

Outcome
Descripción

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

Tipo de datos

text

Severity / Grade
Descripción

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

Tipo de datos

text

Serious
Descripción

Serious

Tipo de datos

boolean

Expected
Descripción

Expected

Tipo de datos

boolean

AE Treatment
Descripción

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

Tipo de datos

text

Action Taken
Descripción

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

Tipo de datos

text

Attribution
Descripción

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

Tipo de datos

text

PI Initials
Descripción

PI Initials

Tipo de datos

text

Date of PI Initials
Descripción

Date of PI Initials

Tipo de datos

date

Similar models

Adverse Event Tracking Log: CRF Wisconsin Madison

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