ID

16968

Descrição

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

Palavras-chave

  1. 17/08/2016 17/08/2016 -
Transferido a

17 de agosto de 2016

DOI

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Licença

Creative Commons BY-NC 3.0

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Adverse Events: UIC Quality Improvement CRF

Adverse Events: UIC Quality Improvement CRF

General Information
Descrição

General Information

Protocol Title
Descrição

Protocol Title

Tipo de dados

text

Site Number
Descrição

Site Number

Tipo de dados

integer

Subject ID
Descrição

Subject ID

Tipo de dados

integer

Visit Date
Descrição

Visit Date

Tipo de dados

date

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

(If yes, please list all Adverse Events below)

Tipo de dados

boolean

Adverse Events
Descrição

Adverse Events

Event Description
Descrição

Event Description

Tipo de dados

text

Start Date
Descrição

Start Date

Tipo de dados

date

Severity (see Description)
Descrição

1= Mild 2= Moderate 3= Severe

Tipo de dados

integer

Action Taken: None
Descrição

Action Taken

Tipo de dados

boolean

Action Taken
Descrição

Action Taken: Discontinued permanently

Tipo de dados

boolean

Action Taken: Interrupted temporarily
Descrição

Action Taken

Tipo de dados

boolean

Action Taken: Reduced Dose
Descrição

Action Taken

Tipo de dados

boolean

Action Taken: Increased Dose
Descrição

Action Taken

Tipo de dados

boolean

Action Taken: Delayed Dose
Descrição

Action Taken

Tipo de dados

boolean

Final Outcome (see Description)
Descrição

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

Tipo de dados

integer

Stop Date
Descrição

Stop Date

Tipo de dados

date

OR: Continuing
Descrição

OR: Continuing

Tipo de dados

boolean

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

Event Analysis: Relationship to Study Intervention (see Description)

Tipo de dados

text

Event Analysis: Expected?
Descrição

Event Analysis: Expected?

Tipo de dados

text

Event Analysis: Serious Adverse Event?
Descrição

Event Analysis: Serious Adverse Event?

Tipo de dados

text

PI Initials
Descrição

PI Initials

Tipo de dados

text

Similar models

Adverse Events: UIC Quality Improvement CRF

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
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
Code List
Event Analysis: Expected?
CL Item
Yes (1)
CL Item
No (2)
Item
Event Analysis: Serious Adverse Event?
text
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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