ID

16635

Description

ODM Form derived from: https://ictr.wisc.edu/CaseReptTempt. Template Name: Subject Deviation/Violation Form. 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 (2)
  1. 7/27/16 7/27/16 -
  2. 11/20/16 11/20/16 -
Uploaded on

July 27, 2016

DOI

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License

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

English

Subject Deviation/Violation Form: 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

Subject Deviation/Unanticipated Event/Violation
Description

Subject Deviation/Unanticipated Event/Violation

Start Date
Description

Start Date

Data type

date

End Date
Description

End Date

Data type

date

Reported Date
Description

Reported Date

Data type

date

Reported By
Description

Reported By

Data type

text

Description of Deviation
Description

Description of Deviation

Data type

text

Deviation Category
Description

Deviation Category

Data type

text

Effect on Patient Care
Description

Effect on Patient Care

Data type

text

Action Taken
Description

Action Taken

Data type

text

Report to the IRB
Description

Report to the IRB

Data type

text

Date Reported to the IRB
Description

Date Reported to the IRB

Data type

date

Principal Investigator Signature
Description

Principal Investigator Signature

Data type

text

Date
Description

Date

Data type

date

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Similar models

Subject Deviation/Violation Form: 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
Item Group
Subject Deviation/Unanticipated Event/Violation
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Reported Date
Item
Reported Date
date
Reported By
Item
Reported By
text
Description of Deviation
Item
Description of Deviation
text
Item
Deviation Category
text
Deviation Category
Code List
Deviation Category
CL Item
Consent Deviation (1)
CL Item
Drug/Device Administration Deviation (2)
CL Item
Enrollment Deviation (3)
CL Item
Procedural Deviation (4)
CL Item
Other (5)
Effect on Patient Care
Item
Effect on Patient Care
text
Action Taken
Item
Action Taken
text
Item
Report to the IRB
text
Report to the IRB
Code List
Report to the IRB
CL Item
Immediately (1)
CL Item
Not applicable (i.e. does not meet Reportable Event criteria) (2)
Date Reported to the IRB
Item
Date Reported to the IRB
date
Principal Investigator Signature
Item
Principal Investigator Signature
text
Date
Item
Date
date
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