ID

16635

Descripción

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

Palabras clave

Versiones (2)
  1. 27/7/16 27/7/16 -
  2. 20/11/16 20/11/16 -
Subido en

27 de julio de 2016

DOI

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Licencia

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

Inglés

Subject Deviation/Violation Form: 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

Subject Deviation/Unanticipated Event/Violation
Descripción

Subject Deviation/Unanticipated Event/Violation

Start Date
Descripción

Start Date

Tipo de datos

date

End Date
Descripción

End Date

Tipo de datos

date

Reported Date
Descripción

Reported Date

Tipo de datos

date

Reported By
Descripción

Reported By

Tipo de datos

text

Description of Deviation
Descripción

Description of Deviation

Tipo de datos

text

Deviation Category
Descripción

Deviation Category

Tipo de datos

text

Effect on Patient Care
Descripción

Effect on Patient Care

Tipo de datos

text

Action Taken
Descripción

Action Taken

Tipo de datos

text

Report to the IRB
Descripción

Report to the IRB

Tipo de datos

text

Date Reported to the IRB
Descripción

Date Reported to the IRB

Tipo de datos

date

Principal Investigator Signature
Descripción

Principal Investigator Signature

Tipo de datos

text

Date
Descripción

Date

Tipo de datos

date

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Similar models

Subject Deviation/Violation Form: 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
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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