ID

18747

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

November 18, 2016

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Alias
UMLS CUI [1]
C0027365
Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Description

Protocol Short Title

Data type

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1705824
Subject Initials
Description

Subject Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Description

Subject ID

Data type

integer

Alias
UMLS CUI [1]
C2348585
Number of Page
Description

Number of Page

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Total Number of Pages
Description

Total Number of Pages

Data type

integer

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0449788
Adverse Event Tracking Log
Description

Adverse Event Tracking Log

#
Description

#

Data type

integer

Date Reported
Description

Date Reported

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1521800
Adverse Event Description
Description

Adverse Event Description

Data type

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C0877248
Adverse Event Category
Description

Adverse Event Category

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0683312
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
End Date
Description

End Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Outcome
Description

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

Data type

text

Alias
UMLS CUI [1]
C1705586
Severity / Grade
Description

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

Data type

text

Alias
UMLS CUI [1]
C0439793
UMLS CUI [2]
C0441800
Serious
Description

Serious

Data type

boolean

Alias
UMLS CUI [1]
C0205404
Expected
Description

Expected

Data type

boolean

Alias
UMLS CUI [1]
C1517001
AE Treatment
Description

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

Data type

text

Alias
UMLS CUI [1]
C2981656
Action Taken
Description

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

Data type

text

Alias
UMLS CUI [1]
C2826626
Attribution
Description

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

Data type

text

Alias
UMLS CUI [1]
C1706735
PI Initials
Description

PI Initials

Data type

text

Alias
UMLS CUI [1,1]
C1521895
UMLS CUI [1,2]
C2986440
Date of PI Initials
Description

Date of PI Initials

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1521895
UMLS CUI [1,3]
C2986440
Back to the top of the page

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
C0027365 (UMLS CUI [1])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Number of Page
Item
Number of Page
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Total Number of Pages
Item
Total Number of Pages
integer
C1704732 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Item Group
Adverse Event Tracking Log
#
Item
#
integer
Date Reported
Item
Date Reported
date
C0011008 (UMLS CUI [1,1])
C1521800 (UMLS CUI [1,2])
Adverse Event Description
Item
Adverse Event Description
text
C0678257 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Adverse Event Category
Item
Adverse Event Category
text
C0877248 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Outcome
Item
Outcome
text
C1705586 (UMLS CUI [1])
Severity / Grade
Item
Severity / Grade
text
C0439793 (UMLS CUI [1])
C0441800 (UMLS CUI [2])
Serious
Item
Serious
boolean
C0205404 (UMLS CUI [1])
Expected
Item
Expected
boolean
C1517001 (UMLS CUI [1])
AE Treatment
Item
AE Treatment
text
C2981656 (UMLS CUI [1])
Action Taken
Item
Action Taken
text
C2826626 (UMLS CUI [1])
Attribution
Item
Attribution
text
C1706735 (UMLS CUI [1])
PI Initials
Item
PI Initials
text
C1521895 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of PI Initials
Item
Date of PI Initials
date
C0011008 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
C2986440 (UMLS CUI [1,3])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial