ID

16629

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Adverse Event Tracking Log. Case Report Form (CRF)/Source Document templates were created for University of Wisconsin-Madison researchers. These templates are consistent with the FDA's CDASH (Clinical Data Acquisition Standards Harmonization) standards. The CDASH standards identify those elements that should be captured on a Case Report Form (CRF). The forms serve only as templates, and must be edited to meet the study data collection needs as described in the protocol.

Link

https://ictr.wisc.edu/CaseReptTempt

Keywords

Versions (2)
  1. 7/27/16 7/27/16 -
  2. 11/18/16 11/18/16 -
Uploaded on

July 27, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Event Tracking Log: CRF Wisconsin Madison

English

Adverse Event Tracking Log: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

Subject Initials
Description

Subject Initials

Data type

text

Subject ID
Description

Subject ID

Data type

integer

Number of Page
Description

Number of Page

Data type

integer

Total Number of Pages
Description

Total Number of Pages

Data type

integer

Adverse Event Tracking Log
Description

Adverse Event Tracking Log

#
Description

#

Data type

integer

Date Reported
Description

Date Reported

Data type

date

Adverse Event Description
Description

Adverse Event Description

Data type

text

Adverse Event Category
Description

Adverse Event Category

Data type

text

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Outcome
Description

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

Data type

text

Severity / Grade
Description

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

Data type

text

Serious
Description

Serious

Data type

boolean

Expected
Description

Expected

Data type

boolean

AE Treatment
Description

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

Data type

text

Action Taken
Description

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

Data type

text

Attribution
Description

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

Data type

text

PI Initials
Description

PI Initials

Data type

text

Date of PI Initials
Description

Date of PI Initials

Data type

date

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Similar models

Adverse Event Tracking Log: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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