ID

16636

Descrizione

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.

collegamento

https://ictr.wisc.edu/CaseReptTempt

Keywords

versioni (3)
  1. 27/07/16 27/07/16 -
  2. 20/11/16 20/11/16 -
  3. 20/06/18 20/06/18 - Julian Varghese
Caricato su

27 luglio 2016

DOI

Per favore, per richiedere un accesso.

Licenza

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

Inglese

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 moduli  
Header
Descrizione

Header

PI Name
Descrizione

PI Name

Tipo di dati

text

Protocol or IRB Number
Descrizione

Protocol or IRB Number

Tipo di dati

integer

Protocol Short Title
Descrizione

Protocol Short Title

Tipo di dati

text

Subject Initials
Descrizione

Subject Initials

Tipo di dati

text

Subject ID
Descrizione

Subject ID

Tipo di dati

integer

Number of Pages
Descrizione

Number of Pages

Tipo di dati

integer

Total Number of Pages
Descrizione

Total Number of Pages

Tipo di dati

integer

Deviation Tracking Log
Descrizione

Deviation Tracking Log

#
Descrizione

#

Tipo di dati

integer

Deviation Start Date
Descrizione

Deviation Start Date

Tipo di dati

date

Deviation Ende Date
Descrizione

Deviation End Date

Tipo di dati

date

Deviation Description
Descrizione

Deviation Description

Tipo di dati

text

Deviation Category
Descrizione

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

Tipo di dati

text

Does the Deviation Impact Subject Safety
Descrizione

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 di dati

text

Does the Deviation Affect Data Integrity
Descrizione

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 di dati

text

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

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 di dati

text

Reported to IRB
Descrizione

Reported to IRB

Tipo di dati

date

Reported to IRB: Not Applicable
Descrizione

Reported to IRB

Tipo di dati

boolean

PI Initials
Descrizione

PI Initials

Tipo di dati

text

Date of PI Initials
Descrizione

Date of PI Initials

Tipo di dati

date

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Similar models

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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
Ritorna all'inizio della pagina 

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