ID

16636

Descripción

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Deviation/Violation 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

Palabras clave

Versiones (3)
  1. 27/7/16 27/7/16 -
  2. 20/11/16 20/11/16 -
  3. 20/6/18 20/6/18 - Julian Varghese
Subido en

27 de julio 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.

Volver a los comentarios del modelo
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.

Subject Deviation/Violation Log: CRF Wisconsin Madison

Inglés

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 formularios  
Header
Descripción

Header

PI Name
Descripción

PI Name

Tipo de datos

text

Protocol or IRB Number
Descripción

Protocol or IRB Number

Tipo de datos

integer

Protocol Short Title
Descripción

Protocol Short Title

Tipo de datos

text

Subject Initials
Descripción

Subject Initials

Tipo de datos

text

Subject ID
Descripción

Subject ID

Tipo de datos

integer

Number of Pages
Descripción

Number of Pages

Tipo de datos

integer

Total Number of Pages
Descripción

Total Number of Pages

Tipo de datos

integer

Deviation Tracking Log
Descripción

Deviation Tracking Log

#
Descripción

#

Tipo de datos

integer

Deviation Start Date
Descripción

Deviation Start Date

Tipo de datos

date

Deviation Ende Date
Descripción

Deviation End Date

Tipo de datos

date

Deviation Description
Descripción

Deviation Description

Tipo de datos

text

Deviation Category
Descripción

1= Consent Deviation 2= Drug/Device Administration Deviation 3= Enrollment Deviation 4= Procedural Deviation 5= Other (describe)

Tipo de datos

text

Does the Deviation Impact Subject Safety
Descripción

If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.

Tipo de datos

text

Does the Deviation Affect Data Integrity
Descripción

If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.

Tipo de datos

text

Does the Deviation Affect Subject´s Willingness to participate?
Descripción

If one or more is answered yes for any deviation, it must be reported to the IRB promptly (14 business days from notification of or becoming aware of the event). Please refer to the HSIRB Reportable Event guidance for additional information.

Tipo de datos

text

Reported to IRB
Descripción

Reported to IRB

Tipo de datos

date

Reported to IRB: Not Applicable
Descripción

Reported to IRB

Tipo de datos

boolean

PI Initials
Descripción

PI Initials

Tipo de datos

text

Date of PI Initials
Descripción

Date of PI Initials

Tipo de datos

date

Volver a la parte superior de la página

Similar models

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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 Pages
Item
Number of Pages
integer
Total Number of Pages
Item
Total Number of Pages
integer
Item Group
Deviation Tracking Log
#
Item
#
integer
Deviation Start Date
Item
Deviation Start Date
date
Deviation End Date
Item
Deviation Ende Date
date
Deviation Description
Item
Deviation Description
text
Deviation Category
Item
Deviation Category
text
Item
Does the Deviation Impact Subject Safety
text
Impact Subject Safety
Code List
Does the Deviation Impact Subject Safety
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item
Does the Deviation Affect Data Integrity
text
Affect Data Integrity
Code List
Does the Deviation Affect Data Integrity
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Item
Does the Deviation Affect Subject´s Willingness to participate?
text
Affect Subject´s Willingness to Participate
Code List
Does the Deviation Affect Subject´s Willingness to participate?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Not Applicable (3)
Reported to IRB
Item
Reported to IRB
date
Reported to IRB
Item
Reported to IRB: Not Applicable
boolean
PI Initials
Item
PI Initials
text
Date of PI Initials
Item
Date of PI Initials
date
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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