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Protocol Deviations

1 forms  
  1. StudyEvent: SE
    1. Protocol Deviations
General information
Description

General information

Alias
UMLS CUI-1
C1508263
Any Deviations?
Description

Indication of whether or not there was a protocol deviation. {NY} (See Section 2.2.)

Data type

text

Alias
CDASH
DVYN
UMLS CUI-1
C2826671
Details
Description

Details

Alias
UMLS CUI-1
C1522508
Protocol Deviation or Other, Specify
Description

Protocol Deviation or Other, Specify DVTERM is the verbatim text.

Data type

text

Alias
CDASH
DVTERM
CDASH/SDTM
DVTERM
UMLS CUI-1
C1705236
Start Date and Time
Description

Start date and time of Deviation.

Data type

text

Alias
CDASH
DVSTDTC
UMLS CUI-1
C2981578
End Date and Time
Description

End date and time of Deviation.

Data type

text

Alias
CDASH
DVENDTC
UMLS CUI-1
C2981575
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Similar models

Protocol Deviations

1 forms
  1. StudyEvent: SE
    1. Protocol Deviations
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General information
C1508263 (UMLS CUI-1)
Item
Any Deviations?
text
DVYN (CDASH)
C2826671 (UMLS CUI-1)
No Yes Response
Code List
Any Deviations?
CL Item
NO (N)
CL Item
YES (Y)
Item Group
Details
C1522508 (UMLS CUI-1)
Protocol Deviation
Item
Protocol Deviation or Other, Specify
text
DVTERM (CDASH)
DVTERM (CDASH/SDTM)
C1705236 (UMLS CUI-1)
Protocol Deviation Start Date Time
Item
Start Date and Time
text
DVSTDTC (CDASH)
C2981578 (UMLS CUI-1)
Protocol Deviation End Date Time
Item
End Date and Time
text
DVENDTC (CDASH)
C2981575 (UMLS CUI-1)
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