ID

16968

Descripción

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

Palabras clave

  1. 17/8/16 17/8/16 -
Subido en

17 de agosto de 2016

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Adverse Events: UIC Quality Improvement CRF

Adverse Events: UIC Quality Improvement CRF

General Information
Descripción

General Information

Protocol Title
Descripción

Protocol Title

Tipo de datos

text

Site Number
Descripción

Site Number

Tipo de datos

integer

Subject ID
Descripción

Subject ID

Tipo de datos

integer

Visit Date
Descripción

Visit Date

Tipo de datos

date

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

(If yes, please list all Adverse Events below)

Tipo de datos

boolean

Adverse Events
Descripción

Adverse Events

Event Description
Descripción

Event Description

Tipo de datos

text

Start Date
Descripción

Start Date

Tipo de datos

date

Severity (see Description)
Descripción

1= Mild 2= Moderate 3= Severe

Tipo de datos

integer

Action Taken: None
Descripción

Action Taken

Tipo de datos

boolean

Action Taken
Descripción

Action Taken: Discontinued permanently

Tipo de datos

boolean

Action Taken: Interrupted temporarily
Descripción

Action Taken

Tipo de datos

boolean

Action Taken: Reduced Dose
Descripción

Action Taken

Tipo de datos

boolean

Action Taken: Increased Dose
Descripción

Action Taken

Tipo de datos

boolean

Action Taken: Delayed Dose
Descripción

Action Taken

Tipo de datos

boolean

Final Outcome (see Description)
Descripción

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 datos

integer

Stop Date
Descripción

Stop Date

Tipo de datos

date

OR: Continuing
Descripción

OR: Continuing

Tipo de datos

boolean

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

Event Analysis: Relationship to Study Intervention (see Description)

Tipo de datos

text

Event Analysis: Expected?
Descripción

Event Analysis: Expected?

Tipo de datos

text

Event Analysis: Serious Adverse Event?
Descripción

Event Analysis: Serious Adverse Event?

Tipo de datos

text

PI Initials
Descripción

PI Initials

Tipo de datos

text

Similar models

Adverse Events: UIC Quality Improvement CRF

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

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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