Engelsk

Subject Deviation/Violation Form: CRF Wisconsin Madison

1 Formulär  
Header
Beskrivning

Header

PI Name
Beskrivning

PI Name

Datatyp

text

Protocol or IRB Number
Beskrivning

Protocol or IRB Number

Datatyp

integer

Protocol Short Title
Beskrivning

Protocol Short Title

Datatyp

text

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Subject ID
Beskrivning

Subject ID

Datatyp

integer

Subject Deviation/Unanticipated Event/Violation
Beskrivning

Subject Deviation/Unanticipated Event/Violation

Start Date
Beskrivning

Start Date

Datatyp

date

End Date
Beskrivning

End Date

Datatyp

date

Reported Date
Beskrivning

Reported Date

Datatyp

date

Reported By
Beskrivning

Reported By

Datatyp

text

Description of Deviation
Beskrivning

Description of Deviation

Datatyp

text

Deviation Category
Beskrivning

Deviation Category

Datatyp

text

Effect on Patient Care
Beskrivning

Effect on Patient Care

Datatyp

text

Action Taken
Beskrivning

Action Taken

Datatyp

text

Report to the IRB
Beskrivning

Report to the IRB

Datatyp

text

Date Reported to the IRB
Beskrivning

Date Reported to the IRB

Datatyp

date

Principal Investigator Signature
Beskrivning

Principal Investigator Signature

Datatyp

text

Date
Beskrivning

Date

Datatyp

date

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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
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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