ID

16636

Description

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

Keywords

Versions (3)
  1. 7/27/16 7/27/16 -
  2. 11/20/16 11/20/16 -
  3. 6/20/18 6/20/18 - Julian Varghese
Uploaded on

July 27, 2016

DOI

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License

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

English

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 forms  
Header
Description

Header

PI Name
Description

PI Name

Data type

text

Protocol or IRB Number
Description

Protocol or IRB Number

Data type

integer

Protocol Short Title
Description

Protocol Short Title

Data type

text

Subject Initials
Description

Subject Initials

Data type

text

Subject ID
Description

Subject ID

Data type

integer

Number of Pages
Description

Number of Pages

Data type

integer

Total Number of Pages
Description

Total Number of Pages

Data type

integer

Deviation Tracking Log
Description

Deviation Tracking Log

#
Description

#

Data type

integer

Deviation Start Date
Description

Deviation Start Date

Data type

date

Deviation Ende Date
Description

Deviation End Date

Data type

date

Deviation Description
Description

Deviation Description

Data type

text

Deviation Category
Description

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

Data type

text

Does the Deviation Impact Subject Safety
Description

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.

Data type

text

Does the Deviation Affect Data Integrity
Description

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.

Data type

text

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

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.

Data type

text

Reported to IRB
Description

Reported to IRB

Data type

date

Reported to IRB: Not Applicable
Description

Reported to IRB

Data type

boolean

PI Initials
Description

PI Initials

Data type

text

Date of PI Initials
Description

Date of PI Initials

Data type

date

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Similar models

Subject Deviation/Violation Log: CRF Wisconsin Madison

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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