ID

18776

Beskrivning

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.

Länk

https://ictr.wisc.edu/CaseReptTempt

Nyckelord

Versioner (2)
  1. 2016-07-27 2016-07-27 -
  2. 2016-11-20 2016-11-20 -
Uppladdad den

20 november 2016

DOI

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Licens

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

Engelsk

Subject Deviation/Violation Form: CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C1521895
Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Alias
UMLS CUI [1]
C2348563
Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C1705824
Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Alias
UMLS CUI [1]
C2986440
Subject ID
Beskrivning

Subject ID

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Subject Deviation/Unanticipated Event/Violation
Beskrivning

Subject Deviation/Unanticipated Event/Violation

Start Date
Beskrivning

Start Date

Datatyp

date

Alias
UMLS CUI [1]
C0808070
End Date
Beskrivning

End Date

Datatyp

date

Alias
UMLS CUI [1]
C0806020
Reported Date
Beskrivning

Reported Date

Datatyp

date

Alias
UMLS CUI [1]
C1302584
Reported By
Beskrivning

Reported By

Datatyp

text

Alias
UMLS CUI [1]
C0700287
Description of Deviation
Beskrivning

Description of Deviation

Datatyp

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0678257
Deviation Category
Beskrivning

Deviation Category

Datatyp

text

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C0683312
Effect on Patient Care
Beskrivning

Effect on Patient Care

Datatyp

text

Alias
UMLS CUI [1,1]
C0017313
UMLS CUI [1,2]
C1280500
Action Taken
Beskrivning

Action Taken

Datatyp

text

Alias
UMLS CUI [1]
C0441472
Report to the IRB
Beskrivning

Report to the IRB

Datatyp

text

Alias
UMLS CUI [1,1]
C0684224
UMLS CUI [1,2]
C0086911
Date Reported to the IRB
Beskrivning

Date Reported to the IRB

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0684224
UMLS CUI [1,3]
C0086911
Principal Investigator Signature
Beskrivning

Principal Investigator Signature

Datatyp

text

Alias
UMLS CUI [1,1]
C1519316
UMLS CUI [1,2]
C1521895
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Subject Deviation/Violation Form: CRF Wisconsin Madison

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Header
PI Name
Item
PI Name
text
C0027365 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Protocol or IRB Number
Item
Protocol or IRB Number
integer
C2348563 (UMLS CUI [1])
Protocol Short Title
Item
Protocol Short Title
text
C2348563 (UMLS CUI [1,1])
C1705824 (UMLS CUI [1,2])
Subject Initials
Item
Subject Initials
text
C2986440 (UMLS CUI [1])
Subject ID
Item
Subject ID
integer
C2348585 (UMLS CUI [1])
Item Group
Subject Deviation/Unanticipated Event/Violation
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1])
Reported Date
Item
Reported Date
date
C1302584 (UMLS CUI [1])
Reported By
Item
Reported By
text
C0700287 (UMLS CUI [1])
Description of Deviation
Item
Description of Deviation
text
C1705236 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Item
Deviation Category
text
C1705236 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
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
C0017313 (UMLS CUI [1,1])
C1280500 (UMLS CUI [1,2])
Action Taken
Item
Action Taken
text
C0441472 (UMLS CUI [1])
Item
Report to the IRB
text
C0684224 (UMLS CUI [1,1])
C0086911 (UMLS CUI [1,2])
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
C0011008 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
C0086911 (UMLS CUI [1,3])
Principal Investigator Signature
Item
Principal Investigator Signature
text
C1519316 (UMLS CUI [1,1])
C1521895 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Tillbaka till toppen 

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