ID

16968

Description

ODM derived from: http://research.uic.edu/qip/toolbox/case-report-forms-crf. Template Name: Adverse Events. QIP Case Report Forms, UIC Quality Improvement CRF, Office of the Vice Chancellor for Research. Center for Clinical and Translational Science, UIC University of Illinois at Chicago.

Link

http://research.uic.edu/qip/toolbox/case-report-forms-crf

Keywords

Versions (1)
  1. 8/17/16 8/17/16 -
Uploaded on

August 17, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Adverse Events: UIC Quality Improvement CRF

English

Adverse Events: UIC Quality Improvement CRF

1 forms  
General Information
Description

General Information

Protocol Title
Description

Protocol Title

Data type

text

Site Number
Description

Site Number

Data type

integer

Subject ID
Description

Subject ID

Data type

integer

Visit Date
Description

Visit Date

Data type

date

Has the subject had any Adverse Events during this study? (See description)
Description

(If yes, please list all Adverse Events below)

Data type

boolean

Adverse Events
Description

Adverse Events

Event Description
Description

Event Description

Data type

text

Start Date
Description

Start Date

Data type

date

Severity (see Description)
Description

1= Mild 2= Moderate 3= Severe

Data type

integer

Action Taken: None
Description

Action Taken

Data type

boolean

Action Taken
Description

Action Taken: Discontinued permanently

Data type

boolean

Action Taken: Interrupted temporarily
Description

Action Taken

Data type

boolean

Action Taken: Reduced Dose
Description

Action Taken

Data type

boolean

Action Taken: Increased Dose
Description

Action Taken

Data type

boolean

Action Taken: Delayed Dose
Description

Action Taken

Data type

boolean

Final Outcome (see Description)
Description

1= Resolved, No Sequelae 2= AE still present - no treatment 3= AE still present - being treated 4= Residual effects present - not treated 5= Residual effects present - treated 6= Death 7= Unknown

Data type

integer

Stop Date
Description

Stop Date

Data type

date

OR: Continuing
Description

OR: Continuing

Data type

boolean

Event Analysis: Relationship to Study Intervention (see Description)
Description

Event Analysis: Relationship to Study Intervention (see Description)

Data type

text

Event Analysis: Expected?
Description

Event Analysis: Expected?

Data type

text

Event Analysis: Serious Adverse Event?
Description

Event Analysis: Serious Adverse Event?

Data type

text

PI Initials
Description

PI Initials

Data type

text

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Similar models

Adverse Events: UIC Quality Improvement CRF

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
Protocol Title
Item
Protocol Title
text
Site Number
Item
Site Number
integer
Subject ID
Item
Subject ID
integer
Visit Date
Item
Visit Date
date
Has the subject had any Adverse Events during this study? (See description)
Item
Has the subject had any Adverse Events during this study? (See description)
boolean
Item Group
Adverse Events
Event Description
Item
Event Description
text
Start Date
Item
Start Date
date
Severity (see Description)
Item
Severity (see Description)
integer
Action Taken
Item
Action Taken: None
boolean
Action Taken
Item
boolean
Action Taken
Item
Action Taken: Interrupted temporarily
boolean
Action Taken
Item
Action Taken: Reduced Dose
boolean
Action Taken
Item
Action Taken: Increased Dose
boolean
Action Taken
Item
Action Taken: Delayed Dose
boolean
Final Outcome (see Description)
Item
Final Outcome (see Description)
integer
Stop Date
Item
Stop Date
date
OR: Continuing
Item
OR: Continuing
boolean
Item
Event Analysis: Relationship to Study Intervention (see Description)
text
Event Analysis: Relationship to Study Intervention (see Description)
Code List
Event Analysis: Relationship to Study Intervention (see Description)
CL Item
Definitely related (1)
CL Item
Possibly related (2)
CL Item
Not related (3)
Item
Event Analysis: Expected?
text
Event Analysis: Expected?
Code List
Event Analysis: Expected?
CL Item
Yes (1)
CL Item
No (2)
Item
Event Analysis: Serious Adverse Event?
text
Event Analysis: Serious Adverse Event?
Code List
Event Analysis: Serious Adverse Event?
CL Item
Yes (Complete an SAE report form) (1)
CL Item
No (2)
PI Initials
Item
PI Initials
text
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