ID

16636

Descrição

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

Palavras-chave

Versões (3)
  1. 27/07/2016 27/07/2016 -
  2. 20/11/2016 20/11/2016 -
  3. 20/06/2018 20/06/2018 - Julian Varghese
Transferido a

27 de julho de 2016

DOI

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Licença

Creative Commons BY-NC 3.0
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Subject Deviation/Violation Log: CRF Wisconsin Madison

Inglês

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 Formulários  
Header
Descrição

Header

PI Name
Descrição

PI Name

Tipo de dados

text

Protocol or IRB Number
Descrição

Protocol or IRB Number

Tipo de dados

integer

Protocol Short Title
Descrição

Protocol Short Title

Tipo de dados

text

Subject Initials
Descrição

Subject Initials

Tipo de dados

text

Subject ID
Descrição

Subject ID

Tipo de dados

integer

Number of Pages
Descrição

Number of Pages

Tipo de dados

integer

Total Number of Pages
Descrição

Total Number of Pages

Tipo de dados

integer

Deviation Tracking Log
Descrição

Deviation Tracking Log

#
Descrição

#

Tipo de dados

integer

Deviation Start Date
Descrição

Deviation Start Date

Tipo de dados

date

Deviation Ende Date
Descrição

Deviation End Date

Tipo de dados

date

Deviation Description
Descrição

Deviation Description

Tipo de dados

text

Deviation Category
Descrição

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

Tipo de dados

text

Does the Deviation Impact Subject Safety
Descrição

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 dados

text

Does the Deviation Affect Data Integrity
Descrição

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 dados

text

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

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 dados

text

Reported to IRB
Descrição

Reported to IRB

Tipo de dados

date

Reported to IRB: Not Applicable
Descrição

Reported to IRB

Tipo de dados

boolean

PI Initials
Descrição

PI Initials

Tipo de dados

text

Date of PI Initials
Descrição

Date of PI Initials

Tipo de dados

date

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Similar models

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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
Voltar ao início da página 

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